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 35241–35260 of 38,428 recalls
Recalled Item: Stryker Howmedica Osteonics Triathlon tibial alignment ankle clamp...
The Issue: Cracks or fracture of the Triathlon Tibial Alignment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL
The Issue: Siemens initiated a recall due to confirmed complaints
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MRidium 1145 Dose Reduction System (DERS) drug library kit. (This
The Issue: The Dose Error Reduction System (DERS) can indicate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RemB Electric Universal Driver For use with the
The Issue: The safety margin values detailed in the Engineering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CORE Universal Driver 99 Rx Only This drill
The Issue: The safety margin values detailed in the Engineering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker TPS Universal Driver 99 Rx
The Issue: The safety margin values detailed in the Engineering
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illico Ti Cannulated Polyaxial Screw 7.5mm X 40mm. The Illico
The Issue: The firm initiated this recall of certain lots
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur Calibrator A. Cat. #04800735
The Issue: Calibrator A lot CA77 is under-recovering to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal Reverse Shoulder System Instrumentation
The Issue: There is potential for one or both tabsof
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trabecular Metal Reverse Shoulder System Instrumentation
The Issue: There is potential for one or both tabsof
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic Preimplantation Test Kit
The Issue: Medtronic Neurosurgery is recalling the Medtronic Preimplantation Test
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25-...
The Issue: The product was registered and distributed as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model
The Issue: High inlet water pressure beyond specification and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA 120 Hematology Analyzer
The Issue: The ADVIA 120 optics cover or hood is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSA Assays for use in the IMMULITE/IMMULITE 1000 Systems Analyzers
The Issue: Customers complained of a positive bias in patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARTIS zee and zeego x-ray
The Issue: Siemens issued a customer safety advisory notice and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533)
The Issue: ADVIA Centaur Homocysteine dilution recovery on the diluent
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Flexi-Seal SIGNAL +
The Issue: ConvaTec notified their customers on 6/25/2013 regarding the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ConvaTec Flexi-Seal SIGNAL Fecal Management System
The Issue: ConvaTec notified their customers on 6/25/2013 regarding the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SC2316
The Issue: The firm became aware of an incident relating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.