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.
Showing 4001–4020 of 38,428 recalls
Recalled Item: Stryker Tornier Perform Humeral System
The Issue: Devices from one lot of Perform" Reversed Inserts
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Good Vibrations Ultrasonic Cleaner Solution
The Issue: Contaminated equipment and packaging caused Klebsiella oxytoca, Enterobacter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus
The Issue: One lot of Perform Humeral Nucleus may exceed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE KIT CV I II
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE OPEN HEART
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE OPEN HEART PACK
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE HEART CABG CDS
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Access TSH (3rd IS) assay is a paramagnetic particle
The Issue: Certain lots of Access TSH reagent packs may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE HEART OVERHEAD TABLE PACK
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE OPEN HEART NIMC KIT
The Issue: Medline Industries, LP. has identified certain kits containing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Sterile Laparoscopy Pack
The Issue: CONMED Corporation (vendor) initiated a recall for select
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAWK Advanced Hypothermia Management Set
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HAWK Warming Grid
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Kits of Convenience containing 1 of the 2 Item Numbers:
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR BLUE
The Issue: Firm identified a potential risk for a fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR RED
The Issue: Firm identified a potential risk for a fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FastPack TSH Calibrator Kit
The Issue: Thyroid Stimulating Hormone (TSH) calibrator card has an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NOVA ORTHO-MED INC. Product Name: MONARCH ROLLATOR PURPLE
The Issue: Firm identified a potential risk for a fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-ablative Fractional Laser Systems
The Issue: Model WFB-01 sold to US customers before Aug
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Diode Laser Hair Removal model: WLA-01
The Issue: All model WLA-01 systems sold to US customers
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.