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 36661–36680 of 38,428 recalls
Recalled Item: Microplate
The Issue: Truncated V-Bottomed Microplate Wells used in assays contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOBASE NON-DERIVATIZED MSMS KIT Product Number: 3040-001U. This tandem mass
The Issue: Truncated V-Bottomed Microplate Wells used in assays contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 2.0K
The Issue: GranuFlo Dry Acid Concentrate may show discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius GranuFlo Naturalyte Dry Acid Concentrate For Bicarbonate Dialysis 1.0K
The Issue: GranuFlo Dry Acid Concentrate may show discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CoverStainer Slide Rack The CoverStainer Slide Rack is an accessory
The Issue: The expected life time of the CoverStainer slide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Antimicrobial Susceptibility Test Discs
The Issue: Boxes labeled as CIP5 may contain cartridges of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Procedural Trays: Merit's Custom Angio Kits A custom procedural
The Issue: Custom Procedural trays contain Medrad Hand Controller Sheaths
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix¿ Positive and
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix¿
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine
The Issue: When these lots of control material are reconstituted,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 Fr 8mm Soft Flow Ang W/L The Sarns Aortic
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 Fr 8mm Sft Flow Straight Wir The Sarns Aortic
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 Fr 8mm Sft Flow Str Wire W/L The Sarns
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 Fr 8mm Sft Flow Straight The Sarns Aortic Cannula
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 18 Fr 6mm Sft Flow Ang Wire W/L The Sarns
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 24 Fr 8mm Soft Flow Ang Wire W/L The Sarns
The Issue: The presence of plastic flash was identified at
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.