Browse Device Recalls
31 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 31 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 31 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 31, 2025 | Olympus OER-Mini | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... | Class II | Aizu Olympus Co., Ltd. |
| Oct 31, 2025 | Olympus OER-Pro | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... | Class II | Aizu Olympus Co., Ltd. |
| Oct 31, 2025 | Olympus OER-Elite | Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | GIF-HQ190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | GIF-H190, EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | PCF-H190DL, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Oct 16, 2023 | PCF-H190L, EVIS EXERA III COLONOVIDEOSCOPE | Specific devices may have an improperly repaired light guide connector due to missing adhesive to... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Uretero-reno fiberscope-For endoscopic diagnosis and treatment within the ure... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysteroscope-For endoscopic diagnosis within the uterus Model Number: HYF-1T. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Mobile airway scope-diagnosis and observation to access airway anatomy, endot... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ultrasonic gastrovideoscope-Real time ultrasound imaging,ultrasound guided ne... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope: for endoscopy and endoscopic surgery within the lower digestive ... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Small intestinal videoscope-For endoscopy and endoscopic surgery within the u... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterofiberscope-For endoscopic diagnosis within the uterus. Model Number:... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Duodenovideoscope-EndoTherapy accessories (such as a biopsy forceps), and oth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastrointestinal videoscope-indicated for use within the upper digestive trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Hysterovideoscope-For endoscopic diagnosis within the uterus Model Number: H... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal videoscope- For airway management, which includes observation to acc... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Cystonephroscope-endoscopic diagnosis and treatment within the bladder, ureth... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Transnasal esophagovideoscope-For endoscopy and endoscopic surgery within the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Ureteralscope- for endoscopic diagnosis and treatment within the ureter, kidn... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging, ultrasoun... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Colonoscope-indicated for use within the lower digestive tract (including the... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal lum... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Bronchoscope-for endoscopy and endoscopic surgery within the airways and trac... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Choleodochoscope. Model Numbers: CHF-BP30, CHF-CB30L, CHF-P60. | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class III | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA) a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Tracheal fiberscope-airway management, which includes observation to access a... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Sep 25, 2023 | Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower dig... | Channel air drying process was not validated, and that a small percentage of scopes returned to c... | Class II | Aizu Olympus Co., Ltd. |
| Jul 20, 2022 | EVIS EXERA III Bronchovideoscope | The recalled unit was utilized in a veterinary endoscopy procedure in advance of being assigned t... | Class II | Aizu Olympus Co., 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.