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 33821–33840 of 38,428 recalls
Recalled Item: ExacTrac 6.0 is a patient positioning and monitoring system. Model/catalogue
The Issue: When using multiple radiation treatment targets within a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AOA Distalizer Lock Nut Screw
The Issue: The Lock Nut component of the Jet appliances
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R S-ROM Noiles Rotating Hinge
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: R
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L S-ROM Noiles Rotating Hinge
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L S-ROM Noiles Rotating Hinge
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RS-ROM Noiles Rotating Hinge
The Issue: DePuy Orthopaedics has identified the potential for holes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDITECH Microbiology
The Issue: for erroneous result reporting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DeRoyal(R) LIMB HOLDERS
The Issue: Moldy smell in product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1)
The Issue: ConMed Corporation initiated an Urgent Medical Device Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS TT4 Calibrator For the quantitative measurement of total thyroxine
The Issue: Total T4 Calibrators and Reagent Packs may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter
The Issue: Biosense Webster is recalling the PentaRay Nav Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proceed Surgical Mesh
The Issue: The possibility exists that an incomplete seal on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use
The Issue: Abbott Diabetes Care has identified through internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FreeStyle Flash Blood Glucose Monitors System. Meter made in China
The Issue: Abbott Diabetes Care has identified through internal testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. and
The Issue: Due to an anomaly in the packaging process
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heparin I.V. Flush Syringe is available is pre-filled polypropylene syringes
The Issue: The bar code that is printed on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur XP Immunoassay system
The Issue: Instrument Cover Gas Spring failures. Over time, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GemStar Docking Station
The Issue: There are two situations that may occur when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.