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 31081–31100 of 38,428 recalls
Recalled Item: Computed Tomography X-ray Systems Ingenuity CT scanners. Intended to produce
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray Systems Ingenuity Core. Intended to produce...
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray Systems Brilliance iCT SP. Intended to produce
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray Systems Ingenuity Core 128. Intended to produce
The Issue: 5 issues. Fast Get Ready incorrectly enabled during
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Computed Tomography X-ray Systems (Brilliance CT 64-channel w/Essence technology
The Issue: Philips discovered that a software defect exists in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medcomp Duo-Flow 400XL Catheter
The Issue: Medcomp has initiated the recall of Duo-Flow 400XL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zip 8i Surgical Skin Closure Device
The Issue: The manufacturers seal may not be present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oxoid Legionella BCYE Growth Supplement SR0110A packaged in packs of
The Issue: Use of the product may not provide adequate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARROW FiberOptix Intra-Aortic Balloon Catheter Kit
The Issue: Outer package product label incorrectly identifies the product
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zimmer Segmental System (ZSS) Cemented Stem / ZSS Cemented Stem
The Issue: PMMA coating does not meet specifications. Area of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zip 8M Wound Closure Device
The Issue: The manufacturers seal may not be present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Zip 16 Surgical Skin Closure Device
The Issue: The manufacturers seal may not be present on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse...
The Issue: Under certain circumstances the patient Demographics in a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture...
The Issue: Measurement values in the EMR may not accurately
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NexGen TRABECULAR METAL FEMORAL AUGMENT BLOCK DISTAL ONLY
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature
The Issue: Images belonging to a different patient were used
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GREER 2 ML Sterile Empty Vials 2-13 vial 25 ea - Silver Cap
The Issue: for glass particles within the vials
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare INTEGRIS vascular System Model : 722122 Product Usage:
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Xper vascular systems R7.6 Model : 722134 Product
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare INTEGRIS H5000F/Allura 9F Model : 722017 Product Usage:
The Issue: Monitor Ceiling Suspension system may fall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.