Browse Device Recalls
389 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 389 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 389 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 11, 2025 | Olympus Inner Sheath, Long; Model No. WA22017T. Inner sheath for urological ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2642. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A22014A and A22014T. for endoscopic diagn... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr.; Model No. A22042A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for uro... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath 21 Fr. Model No. A2660T. for endoscopic diagnosis and t... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath. Model No. A2666T. for endoscopic diagnosis and tre... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. R... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatmen... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic appl... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 8 mm. Model No. A42011A. Resection sheath for gyne... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 26 Fr. with Deflecting Obturator; Model No. A22042T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Inner Sheath, for 26 Fr. Outer Sheath. Model No. A22040A. ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath; Model No. A2660. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 28 Fr.; Model No. A22043A. Resection sheath for ur... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Inner Sheath, Long; Model No. WA22017A. Inner sheath for urological ... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Resection Sheath, 24 Fr., with Deflecting Obturator; Model No. A22041... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Nov 11, 2025 | Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treat... | Complaints of the ceramic tip of the resection sheath breaking have been received. | Class II | Olympus Corporation of the Americas |
| Oct 30, 2025 | Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Mod... | Potential that the ligation loop was unable to release or detach as expected during use, causing ... | Class I | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 45 cm Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 10 cm, Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 17, 2025 | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit P... | Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) in... | Class II | Olympus Corporation of the Americas |
| Oct 14, 2025 | Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V... | Continued reports of positive cultures and infections have identified updates to the reprocessing... | Class II | Olympus Corporation of the Americas |
| Oct 8, 2025 | Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Tr... | The device may either fail to start up, or the transducer may start briefly and then stop, accomp... | Class II | Olympus Corporation of the Americas |
| Oct 6, 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
| Oct 6, 2025 | Brand Name: Olympus Single Use Single Use Electrosurgical Snare SD-400 Produ... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-Q170 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | BRONCHOVIDEOSCOPE OLYMPUS BF-H1100 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
| Sep 11, 2025 | EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180 | Additional IFU updates to provide further clarification on safe and effective use of bronchoscope... | Class I | Olympus Corporation of the Americas |
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.