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 36921–36940 of 38,428 recalls
Recalled Item: Tested AC Control BD
The Issue: Based on a retrospective review of quality data,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The SYMBIONIC LEG is an integrated prosthetic leg for transfemoral
The Issue: OSSUR is recalling the Symbionic Leg because it
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRT-1504/A4 - Titan X MRI System MRT-30 I0A/5 - Titan
The Issue: It was found that there is a problem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Giraffe and Panda Bag and Mask Resuscitation System The T-piece
The Issue: Oxygen and air wall inlet fittings on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare - Giraffe and Panda T-Piece Resuscitation System The
The Issue: Oxygen and air wall inlet fittings on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invivo Corporation Expression MRI Patient Monitoring System. The Expression MRI
The Issue: Invivo Corporation located at 12151 Research Parkway, Orlando,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Large External Fixation
The Issue: It was discovered internally that there was a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Synapse SD Drill Guide
The Issue: A complaint was received from the field, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number:
The Issue: There is a small risk of a leak
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity Enteralite Ambulatory Feeding Pumps
The Issue: The firm is adding an addendum to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Discovery NM/CT670
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens StreamLAB(R) Analytical Workcell
The Issue: Firm has received reports from customers that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated
The Issue: Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Stryker Model 6390
The Issue: Model 6390 Power-LOAD systems built between September 12,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL
The Issue: Correlation slope bias and accuracy shift
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The product is a lyophilized growth supplement for use with
The Issue: The product may contain low level microbial contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Alfa Wassermann System Diluent 750 mL Manufactured for Alfa Wassermann
The Issue: Inorganic phosphorus assays using System Diluent Lot 155599
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ABX PENTRA AST CP
The Issue: Horiba Medical is recalling the ABX PENTRA AST
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PENTRA C200
The Issue: Horiba Medical is recalling the ABX PENTRA AST
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAVIG PORTEGRA 2 system operated in conjuction with a Siemens
The Issue: A particular component may not have been fitted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.