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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.