Medical Device Recalls

This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.

Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.

38,428 total recalls
0 this month

Showing 13321–13340 of 38,428 recalls

January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: KD-620UR ELECTROSURGICAL SNARE

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX LOWER 25G 6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX LOWER 23G 3MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: B-V233P-A 3-LUMEN EXTRACTION BALLOON V

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 25G 4MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX SIF 270CM 23G 4MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 23G 6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: NA-401D-1321 ASPIRATION NEEDLE

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: KD-655U ELECTROSURGICAL SNARE

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: NA-201SX-4022-B ASPIRATION NEEDLE ViziShot 22G

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX UP 2.8MMCH 21G 6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: NEEDLEMASTER 3MMx 23G LOWER

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX SIF 270CM 23G 4MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: NEEDLEMASTER 6MMx 23G LOWER

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Cook Inc.

Recalled Item: Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used

The Issue: Manufactured with incorrect material, which may result in

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: NEEDLEMASTER 5MMx 21G UPPER

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: K-203 GUIDE SHEATH Kit 2.6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX LOWER 23G 6MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated
January 4, 2021· Aomori Olympus Co., Ltd.

Recalled Item: INJECTOR FORCEMAX LOWER 23G 3MM

The Issue: Inspection confirmed a small percentage of sterile packages

Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.

Class II — Potential Health HazardTerminated