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U.S. Department of Health and Human Services

Medical Device Recalls

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Micro-Tech Informer Plus Silver Monitor, Model 81830. The firm name on the label is Stanley Securit... 2 04/28/2012 Stanley Security Solutions, Inc.
UMP Personal Sentry Deluxe Pull String Monitor, Model #91650. The firm on the label is Universal... 2 04/27/2012 Stanley Security Solutions, Inc.
Ultraview SL Patient Monitor, Model 91387. All modules may be affected except Models 90470, 90478, ... 2 05/03/2011 Spacelabs Healthcare, Llc
Crocodile (size 3) are two-armed, wheeled walking aids, used by children with disabilities. Product... 2 12/16/2014 Snug Seat Inc
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L72,Exu-Dry Sheet 36"x72" Non... 2 03/12/2008 Smith And Nephew, Inc. Wound Management Division
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L73, Exu-Dry Sheet 36"x72" No... 2 03/12/2008 Smith And Nephew, Inc. Wound Management Division
Smith & Nephew, Inc., Exu-Dry Wound Burn Dressing, Product Number: 5999L74, Exu-Dry Sheet 36"x72" Pe... 2 03/12/2008 Smith And Nephew, Inc. Wound Management Division
Silhouette Lift brochure Silhouette Sutures are for use in midface suspension surgery to fixate t... 2 07/23/2015 Silhouette Lift, Inc.
Sechrist Low Profile Wheeled Stretcher, Model No. 21762-110-33H, 21762-110-36H, 21762-110-41H, 21762... 2 07/01/2015 Sechrist Industries Inc
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315 2 11/07/2018 Safe N Simple, LLC
Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue numbe... 2 11/07/2018 Safe N Simple, LLC
Breeze C Scooter is a motorized electric scooter for elderly people. Brand name Breeze, model C. ... 2 10/30/2013 S.A.E. AFIKIM
Transport Rollator with Padded Seat; Large 8-inch wheels with wheel locks (indoor and outdoor use), ... 2 11/12/2014 Roscoe Medical Inc
Regard NEWBORN KIT, LD00201j, Item Number: 830016010. Medical convenience kit which includes an in... 2 07/30/2021 ROi CPS LLC
Regard NEWBORN KIT, LD00201K, Item Number: 830016011. Medical convenience kit which includes an in... 2 07/30/2021 ROi CPS LLC
Regard NEWBORN KIT, LD00201M, Item Number: 830016013. Medical convenience kit which includes an in... 2 07/30/2021 ROi CPS LLC
Accu-Chek Inform II Test Strip, Whole blood glucose test system, Catalog no. 05942861001 Product ... 2 05/09/2018 Roche Diabetes Care, Inc.
Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides contin... 1 07/23/2012 Respironics, Inc.
Trilogy 100, 200 and 202 Ventilators The device is intended to be used in home, institution/hospi... 1 01/11/2012 Respironics, Inc.
Blood Agar (TSA w/ 5% Sheep Blood) Plate, For In Vitro Diagnostic Use, Remel, Lenexa, KS 66215 Pr... 2 04/27/2017 Remel Inc
Remel Blood Agar (TSA w/sheep blood) plate REF R01202 packaged 10 plates per pack, 10/10-packs per c... 2 06/10/2015 Remel 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
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 (Large), product number, 537030. Product Usage: The fabric sling is used f... 2 06/19/2013 Prism Medical Services USA
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 (Junior), product number, 537005. Product Usage: The fabric sling is used... 2 06/19/2013 Prism Medical Services USA
Victory 9 with Power Seat (SC609PS) Motorized wheelchair with elevating seat. 2 07/03/2012 Pride Mobility Products Corp
Victory 10, 3 Wheel (SC610) Mobility medical device 2 09/14/2011 Pride Mobility Products Corp
Victory 10, 4 Wheel (SC710) Mobility medical device 2 09/14/2011 Pride Mobility Products Corp
Q-Logic Controller Software used on the following power wheelchairs: Q6000, Q6000XL, Q6000Z, R4000, ... 2 08/27/2008 Pride Mobility Products Corp
Victory Motorized Vehicle, 3 wheel Model SC1600 2 01/05/2005 Pride Mobility Product Corp
Victory Motorized Vehicle 4 wheels Model SC1700 2 01/05/2005 Pride Mobility Product Corp
Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent ventilat... 1 03/06/2014 Phillips Respironics, Inc.
eValueMed Infant Transport Mattress 301-1015, Distributed by Tri-anima A disposable heel warmer for... 2 04/04/2016 Philips Electronics North America Corporation
evaluemed Infant Heel Warmer 301-1223; Distributed by Tri-anim A disposable heel warmer for use whe... 2 04/04/2016 Philips Electronics North America Corporation
Cardinal Health Tiny Toes; 11470-010T Infant heel warmer 2 12/24/2015 Philips Electronics North America Corporation
Permobil Chairman 2K powered wheelchair 2 05/15/2003 Permobile Inc.
Permobil Chairman 2K powered wheelchair, Model 1280 2 03/21/2003 Permobile Inc.
Permobil powered wheelchairs, Model Numbers: (a) M300 PS, (b) C300 PS, (c) C350 PS, (d) C500 PS, (e... 2 09/15/2018 Permobil, Ab
Electric Wheelchair bases: a) C300 b) C350 c) C400 d) C500 2 10/03/2017 Permobil, Ab
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
Permolock C3, Docking system for Power wheelchair in vehicle. Intended use: locking device 2 03/22/2012 Permobil Inc
NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product Number: 3026-0030. ... 2 01/16/2013 Perkinelmer
NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. Th... 2 01/16/2013 Perkinelmer
Fuze Manual Tilt Wheelchair. Fuze T50, Fuze T20 and Fuze T50 Jr 2 09/24/2014 Pdg Product Design Group Inc
MediChoice Dual-Release Folding Walker with 5" wheel 2 11/20/2014 Owens & Minor Distribution, Inc.
Grace Medical REF S-2500 *** SHEEHY BONE DUST COLLECTOR *** Stainless steel filter - Product Usage: ... 2 04/30/2021 Oto Med Inc
The Artificial Bur Patch is a Temporary Fascial Prothesis. For Single Patient Use only. Use with Neg... 2 01/27/2012 Novomedicus Llc
The Artificial Bur HypoPack is a Temporary Fascial Prothesis with Hypobaric Wound Dressing. For Sing... 2 01/27/2012 Novomedicus Llc
Bassinet Models: BSNT/01; BSNT/02, BSNT/03, BSNT/04 The Nemschoff Perinatal Bassinet products are... 1 02/01/2012 Nemschoff Chairs, Inc.
TRx Vertical Positioner, Classification Name: Wheelchair Component - Power Positioning System. 2 09/17/2014 Motion Concepts
Barrier Hip Sheet with Side Pockets 2 08/14/2003 Molnlycke Health Care Inc
Power Wheelchair 2 04/28/2021 Merits Holdings Co. dba Merits Health Products, 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
Bariatric Wheelchair, 26" Wide and 20" Deep Seat, 700 lb. Weight Capacity; Manufactured in Taiwan fo... 2 08/19/2008 Medline Industries Inc
Medline Strider Maxi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh... 2 10/17/2006 Medline Industries Inc
Medline Strider Maxi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao... 2 10/17/2006 Medline Industries Inc
Medline Strider Midi 4 Scooter; a four wheeled battery operated scooter; manufactured by KYMCO, Kaoh... 3 09/23/2006 Medline Industries Inc
Medline Strider Midi 3 Scooter; a three wheeled battery operated scooter; manufactured by KYMCO, Kao... 3 09/23/2006 Medline Industries Inc
DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/C... 2 08/25/2018 Medical Components, Inc dba MedComp
EasyCAL HbA1c Calibrator; REF 10658 Kit is packaged in a paper box containing 4 vials of 0.25ml of ... 2 03/28/2018 Medica Corporation
Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-... 2 11/22/2011 Medi-Physics Inc. dba GE Healthcare
OMNIPORE Surgical Implant Petite Paranasal - Left - Product Usage: OmniPore Surgical Implants in b... 2 04/27/2019 Matrix Surgical Holdings, LLC
OMNIPORE Surgical Implant Petite Paranasal - Right - Product Usage: OmniPore Surgical Implants in b... 2 04/27/2019 Matrix Surgical Holdings, LLC
Prostate Seeding Needle for Use with the Mick Applicator; an 18 gauge needle, 17 cm long with a whit... 3 06/22/2005 Manan Medical Products, Inc.
Light Sheer Desire Diode Laser System with XC Handpiece Accessory options. 2 04/24/2015 Lumenis Limited
Lumenis brand LightSheer Pulsed Diode Array Laser System; All serial numbers; Manufactured by RH US... 2 02/23/2006 Lumenis Inc.
Lumenis brand Lumenis One System with Multi-Spot Nd:YAG, LightSheer and Universal IPL; Manufactured ... 2 02/16/2006 Lumenis Inc.
APhL® HRP IgG & IgM ELISA Kit; Ref. #LAPL-K-HRP-00GM; distributed by Louisville APL Diagnostics, Inc... 2 08/17/2007 Louisville Apl Diagnostics Inc
APhL® HRP IgG ELISA Kit; Ref. #LAPL-K-HRP-001G; distributed by Louisville APL Diagnostics, Inc., Dor... 2 08/17/2007 Louisville Apl Diagnostics Inc
APhL® HRP IgM ELISA Kit; Ref. #LAPL-K-HRP-001M; distributed by Louisville APL Diagnostics, Inc., Dor... 2 08/17/2007 Louisville Apl Diagnostics Inc
Lockheed Martin Aculight Capella-r 1850 Laser. This device has the Accession number 0612339. The... 2 05/19/2011 Lockheed-Martin Aculight
LM Aculight Corporation Perseus Pulsed Fiber Laser, Model number: ML36L-1541. Additional Model numb... 2 04/12/2010 Lockheed-Martin Aculight
Lockheed Martin Gyrocam Systems ( LMGS) LMGS 15" camera systems. Laser pointer and illuminator used ... 2 02/14/2013 Lockheed Martin Gyrocam Systems, Inc.
ST ULTRAPOWER DIAMOND WHEEL (RED) 25.4mm, Catalog Number 00702109200, STERILE, Single-use. Made is... 2 09/08/2009 Linvatec Corp. dba ConMed Linvatec
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
Leica M525 F50 Surgical Microscope; Article No. 10338422; Leica Microsystems (Schweiz) Ag, 201 Max ... 2 07/20/2012 Leica Microsystems, Inc.
Touch Panel/Control Unit Carrier of the Swingarm M820/M844 C19, article no. 10448194MO; a component ... 2 03/21/2012 Leica Microsystems, Inc.
Leica M822 Surgical Microscope Device Controller Software (MDC version 3.6, pack F, affecting the co... 2 02/16/2012 Leica Microsystems, Inc.
Leica M520 Surgical Microscope; a surgical microscope with a 6:1 motorized zoom magnification, 207-4... 2 06/24/2006 Leica Microsystems, Inc.
Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., ... 3 07/20/2004 Lang Dental Mfg Co, Inc.
Jet Tooth Shade Powder, a fast curing temporary crown and bridge acrylic; product code 1410, Net Wt.... 3 07/20/2004 Lang Dental Mfg Co, Inc.
Ortho-Jet Powder, fast curing orthodontic acrylic resin; the product was packaged under the followin... 3 07/20/2004 Lang Dental Mfg Co, Inc.
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla... 2 05/17/2012 Kensey Nash Corp
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla... 2 05/17/2012 Kensey Nash Corp
a translucent, rectangular, resorbable, collagen membrane sheet derived from bovine tissue. Colla... 2 05/17/2012 Kensey Nash Corp
Karma Flexx Wheelchair Manual Wheelchair. 2 02/27/2016 Karman Healthcare Inc
LUCAS 2 Chest Compression System. The device's Instruction for Use is labeled in part: "LUCAS 2... 3 03/16/2011 Jolife AB
Clearview Simplify D-dimer, in vitro diagnostic for qualitative detection of D-dimer in human whole ... 2 03/13/2007 Inverness Medical Professional Diagnostics
Invacare 9805 and 9805P Hydraulic Patient Lifts, Model Nos. 9805 and 9805P The intended use of a ... 2 12/03/2018 Invacare Corporation
Invacare® Pronto® Air Personal Transporter (power wheelchair), Invacare Corporation, One Invacare W... 2 08/10/2015 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
Storm Series Electric Wheelchair. Invacare FDX, TDX series and Storm Series (3G) power wheelchairs i... 2 02/20/2015 Invacare Corporation
MK5 NX Controller--Wheelchair controller 2 07/22/2014 Invacare Corporation
Tracer IV wheelchairs, Heavy duty manual wheel chair, 24" seat width, 450 lbs. weight capacity. Dist... 2 01/08/2014 Invacare Corporation
Invacare Power Wheelchair, one per box To provide mobility to a person restricted to a sitting po... 2 09/23/2013 Invacare Corporation
Solara 3G Custom Manual Wheelchair Product Usage: To provide mobility to a person restricted to... 2 02/04/2013 Invacare Corporation
 
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