Browse Device Recalls

982 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 982 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 982 FDA device recalls.

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DateProductReasonClassFirm
Sep 28, 2012 VENTANA (a member of the Roche Group) BenchMark ULTRA; REF/MU 750-600; Resear... Potiential for a waste fluid overflow condition to accur while running decontamination cycles on ... Class II Ventana Medical Systems Inc
Sep 28, 2012 VENTANA (a member of the Roche Group) DISCOVERY ULTRA; REF/MU 750-601; Resear... Potential for a waste fluid overflow condition to accur while running decontamination cycles on t... Class II Ventana Medical Systems Inc
Sep 27, 2012 VACUETTE Cellestis 1 ml QuantiFERON¿ - TB ANTIGEN; Shake 10x; REF 454074; HE0... Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... Class II Cellestis Inc
Sep 27, 2012 Vacuette Cellestis 1 ml QuantiFERON¿ TB ANTIGEN (HA) High Altitude: Shake 10x... Cellestis is recalling QuantiFERON¿¿ - TB Gold TB Blood Collection Tubes and HA TB Blood Collecti... Class II Cellestis Inc
Aug 30, 2012 Guardian II Hemostasis Valve, Model 8210 and Guardian II NC Hemostasis Valve,... Vascular Solutions, Inc., became aware of a potential problem involving pouches missing a seal fr... Class II Vascular Solutions, Inc.
Jul 13, 2012 INSTRUMENT ARM DRAPE IS2000, 20 PACK: Product Usage: The intended use ... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 Oto Ease by Westone, labeled as a bacteria free, greaseless lubricant. Sold ... Westone is recalling all Oto Ease ear lubricant in all packaging configurations and sizes due to ... Class II Westone Laboratories, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS3000,5 PACK; Product Usage: The inten... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 ACCESSORY BASE STARTER KIT,IS3000; Product Usage: The intended use of... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,4ARM,IS2000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jul 13, 2012 KIT,DISPOSABLE ACCESSORY,3ARM,IS3000,5 PACK; Product Usage: The intend... Specific lots of the Instrument Arm Drapes were manufactured with a sterile adaptor that may have... Class II Intuitive Surgical, Inc.
Jun 27, 2012 Perkin Elmer Genetic Screening Processor (GSP) Product Code: 2021-0010 Pr... Contamination from GSP Shaker unit results in decreased signal activity of assay measurements for... Class II Perkinelmer
Jun 18, 2012 Safe N Simple No-Sting Skin Barrier Film, Ostomy Skin Barrier Wipe, SNS00807 The firm received a customer complaint of observed spots on the wipes. The manufacturer confirmed... Class II Safe N Simple, LLC
Jun 1, 2012 T4-Hytrel Zipper Toga Product Usage - The togas are intended to provide a... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the... Class II Stryker Instruments Div. of Stryker Corporation
Jun 1, 2012 T5 Hytrel Zipper Toga. Product Usage: The togas are intended to provide ... The clear tape, that is intended to aid in the prevention of patients fluids from contacting the ... Class II Stryker Instruments Div. of Stryker Corporation
May 29, 2012 Microbiologics 217 Osseo Avenue North, St. Cloud, MN 56303, Gram Stain Contr... Microbiologics is recalling a number of lots of KWIK-QC Gram Stain Slides. This product gram neg... Class II Microbiologics Inc
May 31, 2011 BioDerm Liberty 3.0 External Male Catheter Specialty Type with integral colle... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
May 31, 2011 BioDerm Safe n' Dry 21006 (Component: SKIN-PREP Protective wipes). The rec... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component (Smith and Nephew skin wipe... Class II BioDerm, Inc.
May 31, 2011 BioDerm Liberty Pouch Clean & Dry External Male Catheter Specialty Type with ... On 06/08/2011, BioDerm, Inc. issued a voluntary recall of a component skin wipes for the BioDerm ... Class II BioDerm, Inc.
Jun 1, 2009 Electrode, Barrel Bar, 24FR (27050NX/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, 24FR (26050G/6). Resectoscope accessories (ie. electrode, c... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Ball End, 24FR (27050N/6). Resectoscope accessories (ie. ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G-.30/6). Resectoscope accessories (ie. ele... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Knife, Cold, Straight (27068K/6). Resectoscope accessories (ie. electrode,... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Loop, Cutting, Angled 22FR (26055G/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, VaporCut, 24FR (27050SG/6). Resectoscope accessories (ie. elect... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Cutting, 24FR, 0.30MM (27040G-.30/6). Resectoscope accessories ... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Coag, Pointed, 24FR (27050L/6). Resectoscope accessories (ie. e... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller Ball, 24FR (27050NK/6). Resectoscope accessories (ie. el... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, Roller, Vaporization, 24FR (27050RK/6). Resectoscope accessorie... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc
Jun 1, 2009 Electrode, cutting, 24FR (27050G/6). Resectoscope accessories (ie. electro... Possible damage to the sterile packaging (blister tray) of some Karl Storz sterile products, whic... Class II Karl Storz Endoscopy America Inc

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.