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 7581–7600 of 38,428 recalls

July 7, 2023· Advance Medical Designs, Inc.

Recalled Item: procedural kits containing ultrasonic transmission gel

The Issue: Mislabeling

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

Class II — Potential Health HazardOngoing
July 7, 2023· Alphatec Spine, Inc.

Recalled Item: LIF AMP

The Issue: Awl instrument adjustable drill button assembly assembled in

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

Class II — Potential Health HazardOngoing
July 6, 2023· Beckman Coulter, Inc.

Recalled Item: Access Thyroglobulin Calibrators

The Issue: It has been determined through an internal investigation

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

Class II — Potential Health HazardOngoing
July 6, 2023· Aquila Corporation

Recalled Item: APK2 Pressure-Sensing Wheelchair Cushions

The Issue: Defective battery pack in wheelchair cushions can overheat

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

Class II — Potential Health HazardOngoing
July 6, 2023· Aquila Corporation

Recalled Item: SofTech Pressure-Sensing Wheelchair Cushions

The Issue: Defective battery pack in wheelchair cushions can overheat

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

Class II — Potential Health HazardOngoing
July 6, 2023· Medtronic Neuromodulation

Recalled Item: Medtronic InterStim Ground Pad

The Issue: Lot of InterStim Self-Adhesive Ground Pad is being

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

Class II — Potential Health HazardOngoing
July 6, 2023· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: TECNIS Symfony

The Issue: Their is a potential that intraocular lenses (IOLs)

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

Class II — Potential Health HazardOngoing
July 6, 2023· Johnson & Johnson Surgical Vision, Inc.

Recalled Item: TECNIS Eyhance IOL

The Issue: Their is a potential that intraocular lenses (IOLs)

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· MEDLINE INDUSTRIES, LP - Northfield

Recalled Item: Total Hip Kit

The Issue: The prep solution included in the Total Hip

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing
July 3, 2023· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Monoblock Hip Stem

The Issue: Increased force may be required to remove the

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

Class II — Potential Health HazardOngoing