Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical Device Recalls
  • Print
  • Share
  • E-mail
-
1 to 100 of 216 Results
Product: hai Recall Date to: 07/12/2015
 
 1 
 2 
 3 
 > 
Results per Page
New Searchexport reports to excelExport to Excel | HelpHelp
Product Description
Sort by Product Name [A-Z]
Sort by Product Name [Z-A]
Recall
Class
Sort by Recall Class [0-9]
Sort by Recall Class [9-0]
FDA Recall
Posting Date
Sort by Date Classified [0-9]
Sort by Date Classified [9-0]
Recalling Firm
Sort by Recalling Firm [A-Z]
Sort by Recalling Firm [Z-A]
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
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
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs i... 2 02/20/2015 Invacare Corporation
Zippie Zone Pediatric Rigid Wheelchair Model EIRZ1. 2 01/27/2015 Sunrise Medical (US) LLC
Quickie Q7 Adult Rigid Wheelchair Model EIR4. 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 Voice + Monitor, includes one wall bracket, Model 25222. Stanley Security Solutio... 2 09/28/2012 Stanley Security Solutions, Inc.
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 pull cord or wall bracket, Model 25025. 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.
Tabs Professional Monitor, without wall bracket, Model 25023. Stanley Security Solutions, Inc., Lin... 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 6550 (STD)/6570 (X-LG) with Drop Arm products are labeled in part: "***CARE CLINER 6550... 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
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
 
 
 1 
 2 
 3 
 > 
 
-
-