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 3181–3200 of 38,428 recalls

December 5, 2024· Waldemar Link GmbH & Co. KG (Mfg Site)

Recalled Item: LINK MP Reconstruction System Neck Segment (with suture holes

The Issue: Error on the main label and the patient

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

Class II — Potential Health HazardOngoing
December 4, 2024· Medtronic Navigation, Inc.

Recalled Item: Medtronic PIN

The Issue: Due to an increase in complaint that the

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

Class II — Potential Health HazardOngoing
December 4, 2024· B. Braun Medical, Inc.

Recalled Item: Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of...

The Issue: Incorrect catheter connector within the kit resulting in

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

Class II — Potential Health HazardOngoing
December 4, 2024· Augustine Temperature Management, LLC

Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING

The Issue: Instructions for use update on HotDog Temperature Management

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

Class II — Potential Health HazardOngoing
December 4, 2024· Augustine Temperature Management, LLC

Recalled Item: Hillrom Temperature Management Controller

The Issue: Instructions for use update on HotDog Temperature Management

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

Class II — Potential Health HazardOngoing
December 4, 2024· Augustine Temperature Management, LLC

Recalled Item: Augustine Surgical Inc. HOT DOG PATIENT WARMING

The Issue: Instructions for use update on HotDog Temperature Management

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

Class II — Potential Health HazardOngoing
December 3, 2024· Medicrea International

Recalled Item: UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002

The Issue: Due to software anomalies that may impact on

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: ECONO STERILE ALFONSO

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing
December 3, 2024· Sklar Instruments

Recalled Item: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE

The Issue: Reports of various packaging issues that may result

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

Class II — Potential Health HazardOngoing