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U.S. Department of Health and Human Services

Medical Device Recalls
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Various Alcon Custom Paks Surgical Procedure Pack containing Oasis 27Ga Chang Hydrodissection Cannul... 2 04/22/2024 Alcon Research, LLC
Scoot Control R-net, Product Number P015-61. The Scoot Control is intended to support a wheelchair a... 2 01/11/2024 mo-Vis BVBA
SofTech Pressure-Sensing Wheelchair Cushions 2 09/18/2023 Aquila Corporation
APK2 Pressure-Sensing Wheelchair Cushions 2 09/18/2023 Aquila Corporation
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.... 2 09/12/2023 Keystone Industries
UFSK Treatment chair 500 XLE- Treatment chair for positioning and support of the patient during diag... 2 07/20/2023 UFSK - International OSYS Gmbh
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC... 2 07/03/2023 DeRoyal Industries Inc
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography (PET) and Computed Tomogra... 2 04/07/2023 Shanghai United Imaging Healthcare Co., Ltd.
Recreo Hair Growth Laser Comb 2 03/14/2023 OMM Imports, Inc. dba Zero Gravity
ActiveAid 922, Shower/Commode Chair 2 01/04/2023 Altimate Medical, Inc.
regard SHOULDER W BCH CHAIR, OR00356F, Item Number 800203006; ortho surgery convenience kit 2 11/23/2022 ROi CPS LLC
FERNO POWER X1 AMBULANCE COT- Item #0015807/UDI-DI 00190790002183 with 36V Li-Ion Batteries Model ... 2 11/04/2022 Ferno-Washington Inc
Allen Life Assist Beach Chair, BCSSP-BEACH CHAIR , REF A-91501, #104002. For use with orthopaedic p... 2 11/03/2022 Baxter Healthcare Corporation
Beach Chair Clamp, BEACH CHAIR SHLDER POSITIONER CMPT, REF A-90013, #800104. Component to position... 2 11/03/2022 Baxter Healthcare Corporation
cobas 5800 instrument, Material No. 08707464001. Used for automated Polymerase Chain Reaction (PCR) ... 2 10/17/2022 Roche Molecular Systems, Inc.
HAIOU Needle retractable safety syringe with needle-(1ml syringe with 25G x 1-inch needle} 200 piec... 2 08/05/2022 Guangdong Haiou Medical Apparatus Co., Ltd
Haiou Needle Retractable Safety Syringe with Needle-1ML 23G x 1 (0.6x25mm). 200pcs/Box Intended Us... 2 08/05/2022 Guangdong Haiou Medical Apparatus Co., Ltd
BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific reagent for the Anti-Kappa antibody, whic... 2 06/01/2022 Becton, Dickinson and Company, BD Biosciences
BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which... 2 06/01/2022 Becton, Dickinson and Company, BD Biosciences
Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators The device is inten... 1 03/18/2022 Philips Respironics, Inc.
Invacare TDX SP2 with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A a... 2 01/03/2022 Invacare Corporation
Invacare AVIVA Storm RX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY... 2 01/03/2022 Invacare Corporation
Invacare AVIVA FX with LiNX Gyro Power Wheelchair (with LiNX Gyro Module Model Numbers DLX-GRY100-A... 2 01/03/2022 Invacare Corporation
Configura Advance Chair, Model Number: CHAIR-0-SC1-030; Advance Chair, 100mm Castors, Std Backrest, ... 2 09/13/2021 Accora Inc
Prime TC-transport chair intended for medical purposes to assist a person in performing an activity... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
Stretcher Chair-for use in all acute care hospitals and medical outpatient services Model Number: 5... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
Michael Graves with Stryker Highback Chair-intended for pediatric and adult person guest and patient... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
TruRize Clinical Chair - support structure that places human occupants in upright, seated, recline, ... 2 08/06/2021 Stryker Medical Division of Stryker Corporation
Revogene SARS-CoV-2 Catalog Number: 410700 IVD for real-time Reverse Transcription Polymerase C... 2 05/07/2021 Meridian Bioscience Inc
Power Wheelchair 2 04/28/2021 Merits Holdings Co. dba Merits Health Products, Inc.
DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent... 2 01/26/2021 Neocis, Inc.
Golden Technologies Model Number PR515 Lift Chair - Product Usage: is to provide lift assistance for... 2 08/17/2020 Golden Technologies, Inc.
DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intende... 2 07/16/2020 Neocis Inc.
DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended... 2 07/16/2020 Neocis Inc.
DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intende... 2 07/16/2020 Neocis Inc.
Quickie/Zippie powered wheelchair. Q700M wheelchair. A battery operated powered wheelchair, which is... 2 05/11/2020 Sunrise Medical (US) LLC
Protective Cover Vivo 55/65 (Used for Vivo 50/65), Part No. 006344. It is an accessory (i.e. protect... 2 02/24/2020 Breas Medical, Inc.
Medtronic Adapter Percutaneous Pin, REF 9734752 (GTIN 00643169529489) and REF 9734752-G02 (GTIN 007... 2 12/19/2019 Medtronic Navigation, Inc.
MEDLINE ELECTRIC SURGICAL CLIPPER AND BASE, REF DYND70800 Product Usage: Medline Surgical Clippe... 2 09/26/2019 Medline Industries Inc
TiLite X-Short anti-tip tubes, models TRA, AERO T, ZRA, AERO Z, 2GX, AERO X, Twist, and AERO R, a co... 2 08/20/2019 TiSport, Llc
Dornier Diode Laser Fibers:Used with Dornier Medilas D Family Lasers Part Number/Description: K100... 2 05/21/2019 Dornier Medtech America, Inc.
Wombat Living, Size 3, Item Numbers: 953121-00, 953126-00, 953131-00, 953132-00, 935-135-00, 9351... 2 05/11/2019 R82 A/S
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intend... 2 01/30/2019 3M Company - Health Care Business
ARJOHUNTLEIGH GETINGE GROUP Flites Passive Clip Sling - Product Usage: The Arjo Passive Clip Sling... 2 12/07/2018 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a ... 2 12/03/2018 Invacare Corporation
Heron toilet and bath chair Model 880505-01 & 880505-11 2 11/09/2018 R82 A/S
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e... 2 09/15/2018 Permobil, Ab
Xpert EV Assay, Catalog GXEV-100N-10. The Cepheid Xpert EV assay is a reverse transcription polym... 2 10/18/2017 Cepheid
Electric Wheelchairs: a) C300 CORPUS II b) C350 CORPUS II c) C400 CORPUS II d) C400 CORPUS II LR... 2 10/03/2017 Permobil, Ab
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 2 10/03/2017 Permobil, Ab
Ferno PROFlexx® Model 28Z Chair Cot 2 04/15/2017 Ferno-Washington Inc
cobas p 512 Pre-Analytical Instrument calculator/data processing module, for clinical use Produc... 2 10/25/2016 Roche Diagnostics Operations, Inc.
TransMotion Medical, TMM3 Series Video-Fluoroscopy Swallow Study Stretcher-Chair. Intended use is... 2 10/10/2016 Winco Mfg., LLC
TransMotion Medical, TMM5 Series Mobile Surgical Stretcher -Chair. Intended use is to provide the... 2 10/10/2016 Winco Mfg., LLC
TransMotion Medical, TMM4 Series Multi-Purpose Treatment Chair. Intended use is to provide the ca... 2 10/10/2016 Winco Mfg., LLC
Quickie Q7 wheelchair. Model EIR4 Physical Medicine. The Quickie Q7 series of wheelchair's inten... 2 07/25/2016 Sunrise Medical (US) LLC
Karma Flexx Wheelchair Manual Wheelchair. 2 02/27/2016 Karman Healthcare Inc
HAILEY ORTHO CONTENDER POST-OP-KNEE BRACE Model : 75-7500-038 Post-Operative Knee Brace is indicat... 2 01/04/2016 Corflex
Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource Bergen), Kroger, Medli... 2 12/16/2015 Bestmed, LLC
miraDry System consisting of the MD4000-MC Console, the MD4000-HP miraDry Handpiece, and the MD4000-... 2 11/06/2015 Miramar Labs, Inc.
DeRoyal Sterile Custom Surgical Kits containing 3M DuraPrep (TM) Surgical Solution, Catalog No. 8630... 2 11/06/2015 DeRoyal Industries Inc
BD CD3 (SK7) FITC; IVD; Catalog # 349201 and 340542 Hematology: The CD3 antibody reacts with the... 3 11/04/2015 Becton, Dickinson and Company, BD Biosciences
Neuro Kinetics, Inc. (NKI) I-Portal® NOTC system with the OVAR research test; a rotary chair system ... 2 09/03/2015 Neuro Kinetics, Inc.
HAIR RESTORATION PACK-THR 12/CS Used by medical staff to perform surgical procedures and patien... 2 09/03/2015 Customed, Inc
Zippie IRIS Wheelchair. model EIZ5A in combination with option code 188M02 - MONO Backrest system wi... 2 08/26/2015 Sunrise Medical (US) LLC
Quickie IRIS Wheelchair. model EIZ4-2 in combination with option code 183M02 - MONO Backrest system ... 2 08/26/2015 Sunrise Medical (US) LLC
Medline Electrical Clipper with Charging base The Electrical Surgical Clipper is intended for th... 2 08/20/2015 Medline Industries Inc
Invacare® Pronto® Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare W... 2 08/10/2015 Invacare Corporation
Block Versions Used by Dental Offices often referred to as chairside milling: Lava Ultimate Rest... 2 07/08/2015 3M Company - Health Care Business
A-dec Decade Plus 1221 Dental Chair This chair is used for positioning dental patient prior to a... 2 06/25/2015 A-Dec Inc
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs i... 2 02/20/2015 Invacare Corporation
FDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2... 2 02/20/2015 Invacare Corporation
TDX Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs in 20 to 2... 2 02/20/2015 Invacare Corporation
Quickie Q7 Adult Rigid Wheelchair Model EIR4. 2 01/27/2015 Sunrise Medical (US) LLC
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. 2 01/27/2015 Sunrise Medical (US) LLC
Powered stretcher chair used during facial and eye surgeries. One chair per package. 2 01/16/2015 TransMotion Medical Inc
Hair Restoration Pack, Catalog #900-2966 Used by medical staff to perform patient care procedures... 1 12/16/2014 Customed, Inc
Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walke... 2 11/14/2014 Silver Star Brands
DMI Duro-Med Industries Rollator Transport Chair; Wheel Size: 7 1/4"; Overall Width: 23 1/2"; Seat H... 2 10/28/2014 Briggs Medical Service Company d.b.a. Mabis
Nemschooff, Model Numbers - Serenity II:790-12, Serenity III: 791-12, Serenity III Exam: 791-12E, an... 2 10/06/2014 Nemschoff Chairs, Inc.
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr 2 09/24/2014 Pdg Product Design Group Inc
Minstrel (with scale) Product Usage: is a mobile passive hoist. It is intended for lifting and t... 2 09/24/2014 ARJOHUNTLEIGH POLSKA Sp. z.o.o.
The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, qualitative test for simulta... 2 09/23/2014 Nanosphere, Inc.
The Verigene Clostridium difficile Nucleic Acid Test (CDF) is a qualitative, multiplexed in vitro di... 2 09/23/2014 Nanosphere, Inc.
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. 2 09/17/2014 Motion Concepts
Tenor is a mobile passive lift, intended to be used on horizontal surfaces for lifting and transfer ... 2 09/16/2014 ARJOHUNTLEIGH POLSKA SP. ZO.O.
Shoulder Pack, Code 900-2616, contains: (2) TUBE SUCTION CONNECT Y."X12' UF (1) SYRINGE 20CC W/0 ... 1 08/29/2014 Customed, Inc
SHOULDER PACK CODE 900-2766 CONTENTS: (1) STAPLE SKIN 35 WIDE LIF (1) *GOBAN SELF-ADH 4" X ... 1 08/29/2014 Customed, Inc
SHOULDER ARTHROSCOPY PACK CONTENTS: (1) SUTURE BAG FLORAL (1) UTILITY BOWL 32oz. (2) DRAPE ... 1 08/29/2014 Customed, Inc
Hair Restoration Pack- , code 900-2966, contains: (1) MAYO STAND COVER 23X54 (2) TOWEL CLOTH HUCK ... 1 08/29/2014 Customed, Inc
SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCE... 1 08/29/2014 Customed, Inc
CURBELL MEDICAL CareSense Wireless Advanced LCD Bed and Chair Monitor, MODEL # CSM-BC400; --- COMMO... 2 08/26/2014 Curbell Medical, Inc.
5 mL Reaction Vessels (a consumable of the Abbott m2000sp Automated Fluid Handling System). The Abbo... 2 08/08/2014 Abbott Molecular
Nanosphere Verigene Each CDF test consists of a Verigene CDF Nucleic Acid Test Kit and a Verigen... 3 08/08/2014 Nanosphere, Inc.
MK5 NX Controller--Wheelchair controller 2 07/22/2014 Invacare Corporation
Stirling Ultracold Portable Shuttle, ULT-25. Storage for cold-chain management, short-term or lon... 2 07/01/2014 Global Cooling Inc
Suture, Non-absorbable, Synthetic, Polyamide, Sterile, Rx only, Product Usage: Non-absorbable p... 2 03/26/2014 Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polyethylene, Sterile, Rx only, Product Usage: Non-absorbab... 2 03/26/2014 Teleflex Medical
Sutures, Absorbable, Synthetic, Polyglycolic Acid, Sterile, Rx only, Product Usage: Non-absorba... 2 03/26/2014 Teleflex Medical
Sutures, Non-absorbable, Synthetic, Polypropylene, Sterile, Rx only, Product Usage: Non-absorba... 2 03/26/2014 Teleflex Medical
Otto Bock Aerial and Aerial Active Wheelchair Cushions. Material numbers: SK757 476C00=SK701, 476C... 2 03/21/2014 Bock,Otto,Orthopedic Ind,Inc
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilat... 1 03/06/2014 Phillips Respironics, Inc.
Punch Hair Matic A surgical hair transplant device designed for automation of follicular transpla... 2 03/04/2014 MEDICAMAT S.A.
CONVALESCENT RECLINER 5251/5261, 525S/526S with Side Storage Pocket, Upholstered side-panels, Recess... 2 02/26/2014 Winco Mfg., LLC
DROP-ARM CONVALESCENT RECLINER 5271/5281 with One-touch release for drop-arms, Built-in headrest, Pa... 2 02/26/2014 Winco Mfg., LLC
XL CONVALESCENT RECLINER 5291/529S with Padded armrests with guard, Dual fold down side-tables, Remo... 2 02/26/2014 Winco Mfg., LLC
PREMIER CARE RECLINER 5570 with Urethane armrests, Multiple side-table options, 3 position lock-bar,... 2 02/26/2014 Winco Mfg., LLC
Superstand stand-up wheelchair HPS-2 A standup wheelchair is a device with wheels that is intend... 2 02/19/2014 The Standing Company
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Dist... 2 01/08/2014 Invacare Corporation
Sunrise Brand Zippie Voyage, Chair with Casters, Early Intervention Device (Stroller), Model: EIZ1... 2 12/05/2013 Sunrise Medical (US) LLC
ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dis... 2 11/18/2013 Restoration Robotics
Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; N... 2 11/18/2013 Restoration Robotics
Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; ... 2 11/18/2013 Restoration Robotics
ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum T... 2 11/18/2013 Restoration Robotics
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting po... 2 09/23/2013 Invacare Corporation
KIT cobas 4800 HPV AMP/DET 240T / 960T US-IVD, CE-IVD Roche Molecular System, Inc. 1080 US highway ... 2 09/10/2013 Roche Molecular Systems, Inc.
CHAMPION Medical Recliner, AC Powered with heat and massage, one chair per carton, or one chair wrap... 2 08/17/2013 Invacare Corporation
Swift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height... 2 07/25/2013 Etac Supply Center Ab
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This produc... 2 06/26/2013 RF Technologies, Inc.
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is ... 2 06/26/2013 ConBio, a CynoSure Company
BC Hammock Mesh Sling (Small), product number, 537010. Product Usage: The fabric sling is used ... 2 06/19/2013 Prism Medical Services USA
BC Hammock Mesh Sling (Large), product number, 537030. Product Usage: The fabric sling is used f... 2 06/19/2013 Prism Medical Services USA
BC Hammock Mesh Sling (Medium), product number, 537005. Product Usage: Usage: The fabric sling... 2 06/19/2013 Prism Medical Services USA
BC Hammock Mesh Sling (Junior), product number, 537005. Product Usage: The fabric sling is used... 2 06/19/2013 Prism Medical Services USA
E-Z WIDER BARIATRIC CHAIR BED; Single Motion Expandable Width Technology 2 06/05/2013 Kreg Medical Inc.
BD ProbeTec Neisseria gonorrhoeae (GC) Qx Amplified DNA Assay Reagent Pack, REF 441124, contains 12 ... 2 05/03/2013 Becton Dickinson & Co.
Chenica Gunnell Rehab Series of Wheelchairs (GRSW); Mechanical Wheelchair, Sold as Rehab Tough and ... 2 02/13/2013 CHENICA INC.
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to... 2 02/04/2013 Invacare Corporation
Ultrawave II EX 1320/ Ultrawave III EX 1320 Powered Laser Surgical Instrument. Nd:YAG 1064 nm: Coag... 2 01/17/2013 Quanta System, S.p.A.
Eterna Giovinezza System, Powered Laser Surgical Instrument. Permanent hair reduction; Photocoagu... 2 01/17/2013 Quanta System, S.p.A.
Q-Plus T Powered Laser Surgical Instrument Nd:YAG 1064 nm and 532 nm: Treatment of vascular lesio... 2 01/17/2013 Quanta System, S.p.A.
Data Station AMPLILINK software is an instrument user interface/ data management software used with ... 2 12/07/2012 Roche Molecular Systems, Inc.
Caremor Cliner"***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***Model No. 536 Serial No... 2 10/10/2012 Winco Mfg., LLC
Caremor Cliner is labeled in part: "***Manufactured By Winco***Ocala, FL 34474 www.wincomfg.com***M... 2 10/10/2012 Winco Mfg., LLC
Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Security Solutions, Inc.... 2 09/28/2012 Stanley Security Solutions, Inc.
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lin... 2 09/28/2012 Stanley Security Solutions, Inc.
Tabs Professional Monitor, without pull cord or wall bracket, Model 25025. Stanley Security Solutio... 2 09/28/2012 Stanley Security Solutions, Inc.
Tabs Professional Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutio... 2 09/28/2012 Stanley Security Solutions, Inc.
Tabs Professional Voice + Monitor, with wire bracket, Model 25223. Stanley Security Solutions, Inc.... 2 09/28/2012 Stanley Security Solutions, Inc.
Invacare® I-Fit" Shower Chair (Models 9780, 9781, 9781-1), Invacare Corporation, Elyria, OH 44035. ... 2 09/26/2012 Invacare Corporation
BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in part***GeneOhm Sciences C... 2 09/06/2012 Becton Dickinson & Co.
BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part***BD Diagnostics, 2555 b... 2 09/06/2012 Becton Dickinson & Co.
Powered Mobility Offers Versatility (M®V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, a... 2 08/22/2012 Stryker Medical Division of Stryker Corporation
Powered Mobility Offers Versatility (M®V)TM Chair The Powered MOV Chair models EMS, EMS24, HHC, a... 2 08/22/2012 Stryker Medical Division of Stryker Corporation
Powered Mobility Offers Versatility (M®V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, ... 2 08/22/2012 Stryker Medical Division of Stryker Corporation
Powered Mobility Offers Versatility (M®V)TM Chair. The Powered MOV Chair models EMS, EMS24, HHC, ... 2 08/22/2012 Stryker Medical Division of Stryker Corporation
Padded Swing Away Arm Rest with Receiver; Uses on wheelchair models: Quickie Q7 (EIR4), GT (EIR3),... 2 07/31/2012 Sunrise Medical (US) LLC
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides contin... 1 07/23/2012 Respironics, Inc.
Sara Plus Mobile Patient Lifter; manufactured for Arjo by Medibo Medical Products N.V., Heikant 5, B... 2 07/06/2012 Arjo, Inc. dba ArjoHuntleigh
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. 2 07/03/2012 Pride Mobility Products Corp
TDX SP Power Wheelchair, TDX SR Power Wheelchair, TDX SI Power Wheelchair. Model Number(s): TDXSI, T... 2 06/29/2012 Invacare Corporation
UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal... 2 04/27/2012 Stanley Security Solutions, Inc.
ELITE CARE CLINER 6900 (STD)/6910(X-LG) with Swing-Arm products are labeled in part: "***ELITE CARE... 2 04/25/2012 Winco Mfg., LLC
CARE CLINER 6530 (STD)/6540 (X-LG) products are labeled in part: "***CARE CLINER 6530/6540 (w/NYLON... 2 04/25/2012 Winco Mfg., LLC
CARE CLINER 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550... 2 04/25/2012 Winco Mfg., LLC
NOCTURNAL ELITE CARE CLINER 6980(STD)/6990(X-LG) products are labeled in part: "***NOCTURNAL ELITE ... 2 04/25/2012 Winco Mfg., LLC
Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device 2 03/22/2012 Permobil Inc
TDX SP Power Wheelchair, Model #'s: TDXSP-CG, TDXSP-CG-GT, TDXSP-MCG, TDXSP-MCG-GT, Distributed By:... 2 03/12/2012 Invacare Corporation
Sunrise Medical Zippie TS wheelchair To empower physically challenged person by providing a means... 2 02/24/2012 Sunrise Medical (US) LLC
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM ... 2 01/25/2012 Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kids... 2 01/25/2012 Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Toug... 2 01/25/2012 Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric ... 2 01/25/2012 Gunnell, Inc.
Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC ... 2 01/25/2012 Gunnell, Inc.
LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleyla... 2 01/11/2012 Covidien, PLC
LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for ... 2 01/11/2012 Covidien, PLC
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospi... 1 01/11/2012 Respironics, Inc.
The National Children's Study Adult Hair Collection Kit/Heritage Labs Westat Adult Hair Collection K... 2 01/11/2012 Heritage Labs International LLC
The National Children's Study Child Hair Kit/Heritage Labs Westat Child Hair Kit, Product A2362, ea... 2 01/11/2012 Heritage Labs International LLC
Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 100 mL, FLOW RA... 1 11/23/2011 Wolf Medical Supply Inc.
Wolf Medical Supply, Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 60 mL, FLOW RA... 1 11/23/2011 Wolf Medical Supply Inc.
Wolf Medical Supply Inc., WOLF-PAK REDI-FLO ELASTOMERIC INFUSION PUMP, FILL VOLUME 270 mL, FLOW RA... 1 11/23/2011 Wolf Medical Supply Inc.
"***UPLIFT TECHNOLOGIES INC.***Bringing quality to life.***Model No.***CA200***Description***Lifting... 2 11/22/2011 Uplift Technologies Inc.
"***Vipat REF H0020-100***Lot 100533***2015-04***STERILE EO Elastomeric pump***2mL/Hr***100mL***Medp... 1 10/24/2011 Victus, Inc.
Medpro AccuFlo Elastomeric Infusion Device, Model #CT-0020-270C, packaged 12/box. The box label sh... 1 10/24/2011 Progressive Medical Inc
Abbott m2000rt System software; an automated system for performing fluorescence-based PCR that resul... 2 10/14/2011 Abbott Molecular
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite. ... 2 09/07/2011 TiSport, Llc
Entroy Pool Lift; a patient lift used in conjunction with a chair or stretcher to lift them in/out ... 2 08/24/2011 Arjo, Inc. dba ArjoHuntleigh
Stryker Evacuation Chair Model 6254 It Is intended to aid in the transportation of passengers up ... 2 08/11/2011 Stryker Medical Division of Stryker Corporation
Stryker EMS Stair - Pro Evacuation Chair Model 6252 It Is intended to aid in the transportation o... 2 08/11/2011 Stryker Medical Division of Stryker Corporation
Factor V Leiden Kit Light Cycler Instrument; Manufactured in Germany for Roche Molecular Systems, In... 2 06/14/2011 Roche Molecular Systems, Inc.
Factor II (Prothrombin) G20210A Kit Light Cycler Instrument; Manufactured in Germany for Roche Molec... 2 06/14/2011 Roche Molecular Systems, Inc.
Dental chairs distributed under several brand names such as DCI Equipment; Marus MaxStar; Marus NuSt... 2 04/12/2011 Dental Equipment LLC
Penner Manufacturing Transfer Electric Pacific Chair, Patient Transfer/Lift System, Models 393000-1... 2 04/08/2011 Penner Mfg Inc
Penner Manufacturing Transfer Electric Pacific Chair with scale, Patient Transfer/Lift System, Mode... 2 04/08/2011 Penner Mfg Inc
Stanley Bed-Check 30-Day IT Chair Sensormat, With 8 Ft. Cord, Model 73010, 10 mats per inner box, 5 ... 2 03/31/2011 Stanley Security Solutions, Inc.
Stanley Bed-Check 90-Day LT Chair Sensormat, With 4 Ft. Cord, Model 73001, 5 mats per inner box, 5 i... 2 03/31/2011 Stanley Security Solutions, Inc.
Stanley Bed-Check 30-Day IT Chair Sensormat, With 4 Ft. Cord, Model 73000, 10 mats per inner box, 5 ... 2 03/31/2011 Stanley Security Solutions, Inc.
Pelton & Crane Spirit 1800 dental chair (Model #SP18) 2 03/30/2011 Pelton & Crane Company
Pelton & Crane Spirit 3000 dental chair (Model #SP30) 2 03/30/2011 Pelton & Crane Company
Factor V Leiden kit catalog number 03610179001, Roche Diagnostics, Indianapolis, IN The Factor ... 2 03/14/2011 Roche Diagnostics Operations, Inc.
Factor II (prothrombin) G20210A kit, catalog number 03610195001, Roche Diagnostics, Indianapolis,... 2 03/14/2011 Roche Diagnostics Operations, Inc.
Abbott RealTime HIV-1 Assay, List 6L18, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Abbott RealTime CT/NG Assay, List 8L07, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL ... 3 02/23/2011 Abbott Molecular
Abbott RealTime HBV Assay, List 2N40, in vitro diagnostic; Abbott Molecular Inc., Des Plaines, IL 60... 3 02/23/2011 Abbott Molecular
Product labeling of the X3 Display reads in part: "XSENSOR Technology Corporation***X3 DISPLAY*** R... 2 01/18/2011 Xsensor Technology Corporation
Manual Wheelchairs with Transit System Option, Model: Quickie LXI (EILXI), Product is manufactur... 2 12/28/2010 Sunrise Medical Inc
Recalled chairs include the following: 2008 Model Numbers: 653N - Care Cliner, 654N - XL Care... 2 10/27/2010 Winco, Inc.
Braun wheelchair lift, model NVL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehic... 2 09/22/2010 The Braun Corporation
Braun wheelchair lift, model NCL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehic... 2 09/22/2010 The Braun Corporation
Braun wheelchair lift, model NL, Braun Corporation, Winamac, IN A wheelchair lift for motor vehicl... 2 09/22/2010 The Braun Corporation
The magnetic headrest is designed to fit the following dental chairs (THE HEADREST IS THE RECALLED I... 2 08/20/2010 Dental Equipment LLC
Pelton & Crane Spirit 3000 Dental Chair. The intended use of this device is for properly positio... 3 04/09/2010 Pelton & Crane Company
Pelton & Crane Dental Chairs, Spirit 3000 with magnetic headrest, Pelton & Crane, Charlotte, NC 2827... 2 04/01/2010 Pelton & Crane Company
Pelton & Crane Dental Chairs, Spirit 2000 with magnetic headrest, Pelton & Crane, Charlotte, NC 2827... 2 04/01/2010 Pelton & Crane Company
Pelton & Crane Dental Chairs, Spirit 1500 with magnetic headrest, Pelton & Crane, Charlotte, NC 2827... 2 04/01/2010 Pelton & Crane Company
Pelton & Crane Dental Chairs, Chairman 5000 with magnetic headrest, Pelton & Crane, Charlotte, NC 28... 2 04/01/2010 Pelton & Crane Company
Pelton & Crane Dental Chairs, Spirit 1800 with magnetic headrest, Pelton & Crane, Charlotte, NC 2827... 2 04/01/2010 Pelton & Crane Company
Invacare Storm TDX SR Power Wheelchair with Stability Lock Model numbers: TDXSR, TDXSR-CG, TDXSR-CG-... 2 12/29/2009 Invacare Corporation
Stille Sonesta Urodynamic Table 6202 Gynecology/Urology Procedure Chair; an electric cystometric tab... 2 12/23/2009 Stille AB
Kuschall K Junior Manual wheelchair 2 11/25/2009 Invacare Corporation
Stryker Medical Stair-PRO Stair Chair with wheels and a track system, patient transport device, Mode... 2 11/09/2009 Stryker Medical Div. of Stryker Corporation
Stryker Medical Stair-PRO Stair Chair with wheels, patient transport device, Model 6251. 2 11/09/2009 Stryker Medical Div. of Stryker Corporation
Leckey 4-Point Pelvic Harness Belts, catalog 081326990; James Leckey Design Ltd., Kilwee Business Pa... 2 09/10/2009 Patterson Medical Holdings, Inc.
ARJO Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactu... 2 09/08/2009 ArjoHuntleigh
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Esteem Blue with Neu Thera Surgeons Glove; a sterile, single use powder-free synthetic polyisoprene ... 2 06/18/2009 Cardinal Health
Stryker Medical Stair-PRO Stair-Chair with wheels and a track system, patient transport device, Mod... 2 02/04/2009 Stryker Medical Div. of Stryker Corporation
Stryker Medical Stair-PRO Stair-Chair with wheels, patient transport device, Model 6251. 2 02/04/2009 Stryker Medical Div. of Stryker Corporation
Stryker Medical Stair-PRO Evacuation Chair civilian use stair chair, patient transport device, Mode... 2 02/04/2009 Stryker Medical Div. of Stryker Corporation
Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Uno 100 EM/EE: S/N 7090001 through 7096200 Uno ... 2 01/27/2009 Liko North America Inc
Liko AB Uno Lifts, Powered (non-AC) Patient Lift: Old Uno 102: S/N 20001 through 21300 New Uno 10... 2 01/27/2009 Liko North America Inc
Invacare Storm TDX SP Power Wheelchair with Stability Lock, Model numbers: TDXSP, TDXSP-CG, and TD... 2 01/27/2009 Invacare Corporation
FS-OMNI, Fusion Omni-Tome, Sterile, Rx only, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Statio... 2 01/05/2009 Cook Endoscopy
High-low:x frame for the x:panda mechanical chair. 2 01/05/2009 Snug Seat Inc
Toddler Chair Hip Strap (Belt). The hip belt is made with nylon webbing and a plastic buckle. 510(k... 3 12/05/2008 Community Products, LLC
BD GeneOhm MRSA 48 ct, Catalog #441244. IDI-MRSA assay is a qualitative in vitro diagnostic test fo... 2 10/31/2008 BD Diagnostics (GeneOhm Sciences, Inc)
BD GeneOhm MRSA 200 ct, Catalog #441242. IDI-MRSA assay is a qualitative in vitro diagnostic test ... 2 10/31/2008 BD Diagnostics (GeneOhm Sciences, Inc)
Premier Value Lancing Device. UPC Code: 840986016707, The Package Includes: 1 Lancing Device, 1 Clea... 2 10/27/2008 Facet Technologies
Sunrise Medical Quickie Groove Power Wheelchair with Transit option The product is a powered wheelc... 2 09/23/2008 Sunrise Medical Inc
Psi Bands acupressure/acustimulation wrist bands in the following colors: Racer Black (UPC 85957000... 2 09/02/2008 Psi Health Solutions
Ambulift Classic, battery powered patient lift. The Ambulift is used to move and lift patients from... 2 08/28/2008 Arjo, Inc.
Ambulift, standard basic model manually powered patient lift. The Ambulift is used to move and lift... 2 08/28/2008 Arjo, Inc.
Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, ... 2 08/27/2008 Pride Mobility Products Corp
GE Healthcare Precision RXi version e Remote X-Ray Imaging R&F System. It is a remote analog R&F s... 2 08/24/2008 GE Healthcare
GE Healthcare Precision RXi 23A/ 32A Remote X-Ray Imaging R&F System. It is a remote analog R&F syst... 2 08/24/2008 GE Healthcare
Quickie Groove Power Wheelchair with QC (non-expandable) electronics, Model number EIPW13. 2 08/23/2008 Sunrise Medical Inc
Quickie Rhythm Power Wheelchair with QC (non-expandable) electronics, Model number EIPW10 2 08/23/2008 Sunrise Medical Inc
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Bariatric Wheelchair, 24" Wide and 19" Deep Seat, 600 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Bariatric Wheelchair, 28" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Freedom Designs TriPod w/Anti tipper Manual Wheelchair, Models Numbers: TriPod, Tripod LT and TriPod... 2 12/19/2007 Freedom Designs Inc
ARJO,Carendo Multi-Purpose Hygiene Chair; Model BIB2003-01, a non-AC powered patient lift; Manufactu... 2 12/01/2007 Arjo, Inc.
Electric Mobility Corporation (EMC)- Scooters and Turnabout Powerchairs with either an Electric Seat... 2 11/21/2007 Electric Mobility Corp
Sunrise Medical Quickie Power Wheelchairs: Three models -Rhythm, Groove, and Zippy Z-Bop (with Quick... 2 08/14/2007 Sunrise Medical Inc
Invacare Storm TDX Power Wheelchair, Models: #TDX3-PS, TDX3-SE-PS, TDX4-PS. 2 07/04/2007 Invacare Corporation
COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLET... 2 03/01/2007 Advanced Medical Optics, Inc.
Eagle Parts and Products Model 624EZ Power Wheel Chairs with internally threaded wheel mount motors. 2 10/19/2006 Eagle Parts and Products
Eagle Parts and Products Model 624Mini Power Wheel Chairs with internally threaded wheel mount motor... 2 10/19/2006 Eagle Parts and Products
Solara Spree GT manual wheelchair. 2 09/20/2006 Invacare Corporation
Solara Spree XT (SPRXT) manual wheelchair. 2 09/20/2006 Invacare Corporation
Solara 2G manual wheelchair. 2 09/20/2006 Invacare Corporation
Kuschall''s K3/K4 Series of Manual Wheelchair, Model Airlite. 2 09/06/2006 Invacare Corporation
Pronto M51 Wheelchair, component- seat 3 08/10/2006 Invacare Corporation
Rascal 600F and 600T scooters, unspecified power wheelchair. 2 05/24/2006 Electric Mobility Corp
Quickie brand Freestyle M11 & F11, C. G. Tilt, Powered Wheelchair; Product is manufactured and d... 2 02/14/2006 Sunrise Medical Inc
3G Storm Series Power Wheelchair with Power Tilt Option. 2 12/23/2005 Invacare Corporation
Pronto Series Power Wheelchair, model M61. 2 06/17/2005 Invacare Corporation
Pronto Series Power Wheelchair, model M51. 2 06/17/2005 Invacare Corporation
Pronto Series Power Wheelchair, model M50. 2 06/17/2005 Invacare Corporation
e-fix E19 power drive. The product is a wheelchair component/accessory. 2 05/06/2005 Frank Mobility Systems, Inc.
e-fix E20 power drive. The product is a wheelchair component/accessory. 2 05/06/2005 Frank Mobility Systems, Inc.
Manual Mechanical Wheelchair, 18'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Co... 2 03/22/2005 Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 24'' seat, , maximum patient weight: 450 lbs.; Marketed by McKesson Co... 2 03/22/2005 Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 16'' seat, , maximum patient weight: 250 lbs.; Marketed by McKesson Co... 2 03/22/2005 Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 20'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Co... 2 03/22/2005 Cypress Medical Products, Ltd.
Manual Mechanical Wheelchair, 22'' seat, , maximum patient weight: 350 lbs.; Marketed by McKesson Co... 2 03/22/2005 Cypress Medical Products, Ltd.
Lift Chairs. Electric Positioning Chair. 2 11/19/2004 Pride Mobility Products Corp
iBOT 3000 Mobility System, Independence iBOT 3000 Mobility System (Stair-climbing wheelchair), Class... 2 10/19/2004 Independence Technology LLC
iBOT 3000 Mobility System. Independence IBOT 3000 Mobility System (Stair-climbing wheelchair), Clas... 2 08/24/2004 Independence Technology LLC
Alenti Lift Hygiene Chair; a non-AC-powered patient lift; Arjo, Inc., 50 N. Gary Ave., Roselle, IL 6... 1 07/20/2004 Arjo, Inc.
Xact(tm) Drop Seat Base, a plastic seat support in Xact (tm) Integrated and Xact Individual w/ Drop ... 2 07/20/2004 Action Products Incorporated
Permobil Chairman 2K powered wheelchair 2 05/15/2003 Permobile Inc.
Twister(tm) Cube Back-Cane Short, a wheelchair back seat support strap, part number WPHS. 2 05/14/2003 Action Products Incorporated
Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs. 2 03/26/2003 Invacare Corp
Permobil Chairman 2K powered wheelchair, Model 1280 2 03/21/2003 Permobile Inc.
Bed/chair alarm 2 01/16/2003 RF Technologies, Inc.
Drop Hooks for Xact (tm) Lo-Pro with Removeable Drop Seat, Xact Integrated, and Xact Individual with... 2 12/05/2002 Action Products Incorporated
 
 
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