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 |
|---|---|---|---|---|
| Jul 16, 2021 | RUSCH Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, RE... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jul 16, 2021 | RUSCH Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF numb... | The firm received reports that the endotracheal tube cuff could be inflated while the pilot ballo... | Class II | Teleflex Medical Europe Ltd |
| Jun 12, 2018 | Teleflex MEDICAL Pilling(R) UNIVERSAL SHEARS 7 1/2", REF 142542 Product Us... | The incorrect plastic was used to manufacture the handles of these shears, which causes the handl... | Class II | Teleflex Medical Europe Ltd |
| Mar 27, 2018 | Teleflex MEDICAL HUDSON RCI One Way Valve w. Capped Monitoring Port, REF 1644... | These one-way valves may disconnect at the joint between the two components that make up the devi... | Class II | Teleflex Medical Europe Ltd |
| Mar 19, 2018 | Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVI... | Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... | Class II | Teleflex Medical Europe Ltd |
| Mar 15, 2018 | Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655... | These products contain latex, but the following statement is not included on any level of product... | Class II | Teleflex Medical Europe Ltd |
| Mar 15, 2018 | Latex Rebreathing Bags: Product Code Equivalent Code (a) 151174050 151174 ... | These products contain latex, but the following statement is not included on any level of product... | Class II | Teleflex Medical Europe Ltd |
| Mar 15, 2018 | Rectal Catheters; Product Code Equivalent Code 580114 580114 ... | These products contain latex, but the following statement is not included on any level of product... | Class II | Teleflex Medical Europe Ltd |
| Mar 15, 2018 | Simplastic Suprapubic Puncture Instruments: Product Code Equivalent... | These products contain latex, but the following statement is not included on any level of product... | Class II | Teleflex Medical Europe Ltd |
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.