Browse Device Recalls
26 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 26 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 26 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Apr 6, 2016 | Confocal GI Scope Product Usage: Intended to provide optical visualizatio... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Naso-Pharyngo-Laryngoscope Intended to provide optical visualization of, the... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Gastroscope Intended to provide optical visualization of and therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Choledochoscope Intended to provide optical visualization of and therapeutic... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Confocal GI Scope Intended to provide optical visualization of an therapeuti... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Choledocho-Nephroscope Intended to provide optical visualization of and ther... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Duodenoscope Product Usage: Intended to provide optical visualization of ... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Cystoscope Intended to provide optical visualization of and therapeutic acce... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ureteroscope Intended to provide optical visualization of and therapeutic ac... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Esophagoscope Gastrointestinal Tract. This anatomy includes, but is not rest... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Gastroscope Product Usage: Intended to provide optical visualization of a... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ultrasound Gastroscope Intended to provide optical visualization of, ultraso... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ultrasound Bronchoscope Intended to provide optical visualization of, ultras... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Signmoidoscope Intended to provide optical visualization of, therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Ultrasound Gastroscope Product Usage: Intended to provide optical visuali... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Laryngo Stroboscope Product Usage Intended to provide optical visualization ... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Small Bowel Scope Gastrointestinal Tract. This anatomy includes, but is not ... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Colonoscope Product Usage: Intended to provide optical visualization of a... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Intubation Scope Intended to provide optical visualization of, therapeutic a... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Colonoscope Intended to provide optical visualization of and therapeutic acc... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Bronchoscope Intended to provide optical visualization of and therapeutic ac... | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clip... | Class II | Pentax Medical Company |
| Apr 6, 2016 | Signmoidoscope Product Usage: Intended to provide optical visualization o... | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bo... | Class II | Pentax Medical Company |
| Feb 22, 2016 | Video Duodenoscope | Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a... | Class II | Pentax Medical Company |
| Jul 17, 2014 | PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve | The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed c... | Class II | Pentax Medical Company |
| Jun 12, 2014 | EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope... | Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory... | Class II | Pentax Medical Company |
| Sep 16, 2013 | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lowe... | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding ... | Class I | Pentax Medical Company |
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.