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 34381–34400 of 38,428 recalls
Recalled Item: Sunrise Brand Zippie Voyage
The Issue: There is a remote possibility for the plastic
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD 100NX
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STERRAD NX
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB)
The Issue: for a leak between the catheter and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 800 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the UniCel DxH800 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxH 600 Coulter Cellular Analysis System
The Issue: Beckman Coulter is recalling the UniCel DxH800 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter DxH Cleaner 5L
The Issue: Beckman Coulter is recalling the UniCel DxH800 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter DxH Cleaner 10L
The Issue: Beckman Coulter is recalling the UniCel DxH800 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API NH () API NH is a standardized system
The Issue: bioM¿rieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: API Listeria () API Listeria is a standardized system
The Issue: bioM¿rieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYM B Reagent () ZYM B reagent is an
The Issue: bioM¿rieux identified a visual defect and activity issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Video Monitor Suspensions that may be on the following Fluoroscopic
The Issue: Missing screws in the overhead Video Monitor Suspension
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes
The Issue: Following a retrospective review for Baxter Daytona Complaint
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProPlan CMF Guide(s) Model(s) .008 Description: Single Use Only
The Issue: Patient Specific Guide contained the incorrect case report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ProPlan CMF Guide(s) Model(s) .008 Description: Single Use Only
The Issue: Patient Specific Guide contained the incorrect case report
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FastPack Free T4 Immunoassay FastPack Vitamin D Immunoassay Chemilunescence...
The Issue: Qualigen initiated this recall because the FastPack kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FastPack Testosterone Immunoassay Chemilunescence assay for the...
The Issue: Qualigen initiated this recall because the FastPack kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FastPack Total PSA Immunoassay Chemilunescence assay for the determination of
The Issue: Qualigen initiated this recall because the FastPack kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FastPack Free T4 Immunoassay Chemilunescence assay for the determination of
The Issue: Qualigen initiated this recall because the FastPack kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coulter LH 750 Hematology Analyzer
The Issue: Beckman Coulter is recalling the LH 750 and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.