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 7081–7100 of 38,428 recalls

September 26, 2023· B. Braun Medical, Inc.

Recalled Item: FT1000S FLUID TRANSFER SET

The Issue: Devices may leak as a result of a

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

Class II — Potential Health HazardOngoing
September 26, 2023· B. Braun Medical, Inc.

Recalled Item: SA3000 VENTED MICRO SPIKE ADAPTER

The Issue: Devices may leak as a result of a

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

Class II — Potential Health HazardOngoing
September 26, 2023· B. Braun Medical, Inc.

Recalled Item: BULK LARGEBORE MALE LL FITTING

The Issue: Devices may leak as a result of a

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DBM (Flex)

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DMB Matrix

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DBM Orthoblend

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton Plus DBM Paste

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DBM Putty

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DBM Matrix Strips

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 26, 2023· Medtronic Sofamor Danek USA Inc

Recalled Item: Grafton DBM Crunch

The Issue: Specific serial numbers of GraftonTM DBM product due

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

Class II — Potential Health HazardOngoing
September 25, 2023· Olympus Corporation of the Americas

Recalled Item: Insufflation unit

The Issue: Olympus has become aware of an increased trend

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Signmoidovideoscope-For endoscopy and endoscopic surgery within the lower...

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Tracheal fiberscope-airway management

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Gastroscope-endoscopic ultrasound (EUS) guided fine needle aspiration (FNA)...

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Choleodochoscope. Model Numbers: CHF-BP30

The Issue: Channel air drying process was not validated, and

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

Class III — Low RiskOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Bronchoscope-for endoscopy and endoscopic surgery within the airways and...

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Rhinolaryngoscope-for endoscopic diagnosis and treatment within the nasal...

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Colonoscope-indicated for use within the lower digestive tract (including the

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Bronchoscope - Ultrasonic: endoscopic real-time ultrasonic imaging

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing
September 25, 2023· Aizu Olympus Co., Ltd.

Recalled Item: Ureteralscope- for endoscopic diagnosis and treatment within the ureter

The Issue: Channel air drying process was not validated, and

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

Class II — Potential Health HazardOngoing