Browse Device Recalls
7 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 7 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 7 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2016 | Puritan Bennett 980 Ventilator System, PB980 Ventilator (980xxxxxxxx). Int... | Graphical user interface (GUI) unresponsive to touch and Loss of primary ventilation under certai... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jul 16, 2015 | Puritan Bennett 980 Ventilator System, Universal (with neonatal functionality... | Reports in which tidal volumes reaching patients were lower than set tidal volumes in neonatal Vo... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For c... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jun 29, 2015 | OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of func... | Potential missing segments on the display that can result in misinterpretation of data. | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube with TaperGua... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| May 8, 2015 | Shiley Neonatal, Pediatric and Long Pediatric Tracheostomy Tube, Cuffless. M... | Reports where patients who recently switched from the current Shiley Neonatal and Pediatric produ... | Class I | Covidien LP (formerly Nellcor Puritan Bennett I... |
| Jan 12, 2015 | Puritan Bennett 980 Ventilator System, Model No. PB980 Ventilator (980xxxxxxx... | Covidien is issuing a voluntary field action for all Puritan Bennett 980 ventilators due to occas... | Class II | Covidien LP (formerly Nellcor Puritan Bennett I... |
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.