Browse Device Recalls
264 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 264 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 264 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.0, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 8.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 6.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port and Prel... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Jan 6, 2014 | ISIS HVT Tracheal Tube Cuffed with Subglottic Secretion Suction Port, 7.5, Rx... | The tracheal tube can kink during patient use. | Class I | Teleflex Medical |
| Dec 19, 2013 | Weck, Electrosurgical Coagulation Suction Tube 6 (15.2cm), 11 French, with S... | Sterility cannot be guaranteed. | Class II | Teleflex Medical |
| Dec 19, 2013 | Weck, Electrosurgical Coagulation Suction Tube 8 (20.0cm), 11 French, with S... | Sterility cannot be guaranteed. | Class II | Teleflex Medical |
| Oct 15, 2013 | Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upp... | Labeling inconsistency | Class II | Teleflex Medical |
| Aug 8, 2013 | Horizon 24 Large Titanium Clips with Adhesive Backing, Ref 004204, Rx Only, S... | The manufacturing and expiration dates are not printed on the blister pack label. | Class II | Teleflex Medical |
| Mar 28, 2013 | Belly Bag Urine Collection Bag with Hip Belt. The product is a sterile uri... | Sterile packaging may be compromised. | Class II | Teleflex Medical |
| Mar 4, 2013 | Arrow/Teleflex Medical Berman Angiographic Balloon Catheter and Reverse Berma... | The product specifications sheet, part of the Instructions for Use (IFU), for the specified produ... | Class II | Arrow International Inc |
| Sep 25, 2012 | Hem-o-lok Large Polymer Ligating Clips, REF #544240, Rx only, Sterile, Telefl... | Product is being recalled due to the possibility that the tray may contain pinholes, compromising... | Class II | Teleflex Medical |
| Jul 20, 2012 | TAUT, Cholangiogram Catheter Intraducer, Peritoneal Catheter, Teleflex Medica... | Product is missing the label on the internal packaging. | Class III | Teleflex Medical |
| Jun 12, 2012 | Hudson RCI Concha Therm Neptune Humidifier, Rx Only, Product Usage: Usag... | Speaker Failure. If the speaker fails and an event occurs which would generate an audio alarm, th... | Class II | Teleflex Medical |
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.