Browse Device Recalls
11 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 11 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 11 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 12, 2014 | R¿SCH Curved Reinforced Endotracheal Tube: Rusch Reinforced Endotracheal Tube... | Teleflex Medical has issued an advisory notification for the RUSCH Curved Reinforced Endotracheal... | Class II | Teleflex, Inc. |
| Dec 4, 2014 | MAQUET Servo Humidifier 163; Model No.: 01-06-8125-8, catalog no. XKC01-06-81... | Connector mount cracks which may lead to a leak failure during use and necessitate immediate repl... | Class I | Teleflex, Inc. |
| Nov 21, 2014 | Tracheopart Set (Left), Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | White Bronchial Double Lumen Tube Set (Right) Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Bronchial Double Lumen Tube Set (Left), Extra Length, Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Tracheopart Set (Right), Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Bronchial One Lumen Tube - Right | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Bronchial Double Lumen Tube Set (Left), Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Bronchial One Lumen Tube - Left | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Bronchial Double Lumen Tube Set (Right), Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, Inc. |
| Nov 21, 2014 | Carlens Bronchial Double Lumen Tube Set (Left) Sterile | Customer complaints reporting that the cobb connector detached from the main connector prior to use. | Class II | Teleflex, 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.