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 36361–36380 of 38,428 recalls
Recalled Item: Plastic bottle containing 3.5 mL of IgG FITC Conjugate Product
The Issue: Affected products have a labeled expiration date of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular
The Issue: Bard Peripheral Vascular (BPV) is initiating this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MICROSHEATH¿ - 0.066 (1.7mm) proximal
The Issue: Bard Peripheral Vascular (BPV) is initiating this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: USHER¿ Support Catheter- Angled Tip WL130cm
The Issue: Bard Peripheral Vascular (BPV) is initiating this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular
The Issue: Bard Peripheral Vascular (BPV) is initiating this recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plastic bottle containing 10.5 mL of IgG Conjugate Product Usage:
The Issue: Affected products have a labeled expiration date of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plastic bottle containing 10.5 mL of IgM Conjugate Product Usage:
The Issue: Affected products have a labeled expiration date of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medium 2-Hooks Spreader Bar for use with Loop Slings
The Issue: The upper portion of the hooks on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee systems x-ray
The Issue: The firm became aware of a potential issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardinal Health hCG Cassette Rapid Test
The Issue: Alere San Diego Inc. is recalling the Cardinal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Advantx
The Issue: A locking nut might loosen out of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lifeguard Infusion Set with Smartsite
The Issue: The label on the device states that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity TF PET/CT. Diagnostic imaging system
The Issue: The system may not default to the same
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON S2000 Automated Breast Volume Scanner (ABVS)
The Issue: On some ACUSON S2000 ABVS systems, the inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta
The Issue: If the Apex collimator is incorrectly installed on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aesculap Bipolar Generator Foot Pedal
The Issue: The bipolar energy did not stop after release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chenica Gunnell Rehab Series of Wheelchairs (GRSW)
The Issue: The wheelchairs may not meet the specifications of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: St. Jude Medical
The Issue: The distal end of the core wire of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SybronEndo Replacement AC Power Cord
The Issue: A recall has been issued by SybronEndo because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SybronEndo Elements Obturation Unit
The Issue: A recall has been issued by SybronEndo because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.