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 23281–23300 of 38,428 recalls
Recalled Item: Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
The Issue: Vix Bit may fracture during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT - Model 728306 Computed Tomography X-ray systems
The Issue: Numerous software issues with Brilliance iCT 4.1.6 version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT SP - Model 728311 Brilliance iCT - Model
The Issue: Numerous software issues with Brilliance iCT 4.1.6 version
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Scientific Solutions Americas Corporation ( OSSA ) Model: VANTA...
The Issue: Instruments may, under certain specific circumstances listed below,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Chemistry Products Performance Verifier is used as an assayed
The Issue: VITROS Performance Verifier II (PVII) Lot K4852 does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radial Artery Catheterization Set
The Issue: Needle supplier indicated the presence of loose polypropylene
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended
The Issue: Two specific lots was incorrectly manufactured containing a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPLANT
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Guide Sleeve 3.25
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABUT GOLD FRICTION-FIT
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WAXING COPING
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TRY-IN
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMPRESSION CAP CONT 3.5MM
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: THREAD RETRIEVAL DRILL
The Issue: Zimmer Biomet is conducting a medical device field
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ondamed Biofeedback Device
The Issue: The firm was marketing the Ondamed System in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Affirm Lateral Arm Upright Biopsy Accessory. Product Number: ASY-09880
The Issue: The firm is implementing a product correction involving
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mac Pin Non-Cannulated Screw
The Issue: Incorrect labeling for the lot of MAC Pins
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws
The Issue: Incorrect direct marking and color identification for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Qualigen(R) The FastPack(R) IP Vitamin D Complete Immunoassay Kit
The Issue: Specific lots have been reported to produce falsely
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fogarty Adherent Clot Catheter Model Numbers 1408010 and 140806 Product
The Issue: The diameter of the Fogarty Catheter balloon, measures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.