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 36521–36540 of 38,428 recalls
Recalled Item: Needle Counters with Blade Disarmer
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT HBsAg Qualitative Assay
The Issue: Abbott has identified that assay files for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters with Blade Disarmer
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Needle Counters with Blade Disarmer
The Issue: Small holes (approximately 1 mm or less) found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ad-Tech Medical Instrument Corporation Macro Micro Subdural Electrode. For...
The Issue: The microelectrodes are not flush with the silastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Surgical Bed
The Issue: Stryker Medical Model 3002S3EX and Model 3005S3EX beds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Surgical Bed
The Issue: Stryker Medical Model 3002S3EX and Model 3005S3EX beds
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Churchill Medical Systems
The Issue: Product was packaged with the incorrect introducer needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Animas(R) 2020
The Issue: Due to an internal calendar date limit (December
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mizuho Orthopedic Table
The Issue: instability of Orthopedic Table Top. If the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medacta Quadra Trial Broach size 0 part # 01.10.10.045
The Issue: The tip of the Quadra Trial Broach size
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QuietCare-Networked product
The Issue: Care Innovations detected a software anomaly: During the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Non-DEHP Micro-Volume Extension Set
The Issue: Some of the individual extension set packages were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated
The Issue: Riverpoint Medical is recalling PGLA Surgical Suture (Vilet)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SR Instruments FG3105 Patient Scales Used on various Joerns Healthcare
The Issue: SR Instruments Inc. is implementing a field correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number
The Issue: The displayed value for the invasive blood pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item:
The Issue: The affected product was packaged with the incorrect
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ortho Clinical Diagnostics VITROS¿ Chemistry Products Vapor Adsorption...
The Issue: Some VITROS¿ Chemistry Products Vapor Adsorption Cartridge CAT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juno DRF
The Issue: Values of fluoroscopy time, Air Kerma Rate and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.