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 36641–36660 of 38,428 recalls
Recalled Item: Immunoradiometric assay. Device is an immunoradiometric assay designed for the
The Issue: The recall was initiated because Siemens Healthcare Diagnostics
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle Cancellous Screw Packaging: Product is housed within a polyurethane
The Issue: DePuy Orthopaedics, Inc. is issuing a voluntary recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TCM4 series Base Units
The Issue: RADIOMETER became aware that the TCM4 series Base
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr
The Issue: to have an internal leak at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr
The Issue: to have an internal leak at the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR...
The Issue: Siemens has confirmed customer complaints of low patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Somatom CTs equipped with software syngo CT2010A
The Issue: Sporadic hang-up malfunctions concerning 3D reconstructions during activated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fresenius GranuFlo Dry Acid Concentrate For Bicarbonate Dialysis 2.0 K
The Issue: GranuFlo Dry Acid Concentrate may show discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Axiom Artis zeego systems with software version VC14
The Issue: In the course of the firm's product monitoring
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Breast Biopsy Tray w/Sodium Chloride
The Issue: Surgical procedure trays are packed with pharmaceuticals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Breast Biopsy Tray
The Issue: Surgical procedure trays are packed with pharmaceuticals for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DBS 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: NEONATAL TOTAL GALACTOSE KIT Product Numbers: 3029-0010
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 3.0K
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 3.0K
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 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 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 3.0K
The Issue: GranuFlo Dry Acid Concentrate may show discoloration
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NEOGRAM AMINO ACIDS AND ACYLCARNITINES TANDEM MASS SPECTROMETRY KIT Product
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.