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 13401–13420 of 38,428 recalls

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

Recalled Item: NEEDLEMASTER 6MMx 23G 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: KD-612L ELECTROSURGICAL KNIFE

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 25G 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: B7-2C BALLOON CATHETER 13mm dia 2.8

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 4MMx 26G 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 LOWER 23G 5MM

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: SD-400U-10 SNAREMASTER PLUS Hot/Cold 10m

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 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: NEEDLEMASTER 1.8MMx 26G 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 UP 2.8MMCH 23G 5MM

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 25G 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: INJECTOR FORCEMAX UP 2MM CH 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: NEEDLEMASTER 4MMx 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 UP 2MM CH 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: B-V243Q-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 5MM

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: CRESCENT 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-411D-1521 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: SD-210U-10 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: NEEDLEMASTER 4MMx 26G 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