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 32621–32640 of 38,428 recalls
Recalled Item: Darby Dental Supply Compolite Bond SE Self-Etch/Light-Curing. This product is
The Issue: Septodont is recalling Self-Etch bond because the material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices
The Issue: The Reagent Lid hinge may lose its effectiveness
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TomoTherapy Treatment System
The Issue: Accuray is voluntarily recalling TomoTherapy H Series software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Henry Schein Natural Elegance SE Bond Self-Etch Light-Cure Adhesive contains
The Issue: Septodont is recalling Self-Etch bond because the material
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiomat M+ NIF 14 x 17
The Issue: Some sheets of the medical screen film are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Immunodiagnostic Products CA 19-9 Calibrators and Reagent Packs
The Issue: Customers may receive positively biased results when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AB SCIEX API 3200MD" LC/MS/MS System with software: MultiQuantMD 3.0In
The Issue: Software- AB SCIEX API 3200MD LC/MS/MS SYSTEM with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a
The Issue: The cautery that is provided with the Gelweave
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Dimension Chemistry Wash (RD701) is an accessory of the
The Issue: Siemens Healthcare Diagnostics has received complaints for the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Chemistry Products CDM PROM Calibration Data Module Rev. No.
The Issue: Inability to calibrate or use VITROS NH3 DT
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip...
The Issue: Baxter Healthcare Corporation is voluntarily issuing a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip...
The Issue: Baxter Healthcare Corporation is voluntarily issuing a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m)
The Issue: Baxter Healthcare Corporation is voluntarily issuing a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medtronic
The Issue: Medtronic is recalling six Activa PC (model 37601)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Hydrogel Saturated Gauze Dressing
The Issue: Not approved labeling claims (antimicrobial and autolytic debridement)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Daily Dressing Advanced 3-in-1 Hydrogel
The Issue: Not approved labeling claims (antimicrobial and autolytic debridement)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Wound Dressing Maximum Strength CAT# A2001. Wound management.
The Issue: Not approved labeling claims (antimicrobial and autolytic debridement)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Amerigel Post-Op Surgical Kits . Kit includes: Amerigel Wound Dressing
The Issue: Not approved labeling claims (antimicrobial and autolytic debridement)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tibila Insert UC
The Issue: Ortho Development is recalling various Pivot Bipolar Cup,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PS Tibial Insert
The Issue: Ortho Development is recalling various Pivot Bipolar Cup,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.