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 37601–37620 of 38,428 recalls
Recalled Item: Aesculap(R) - Miethke Shunt System
The Issue: The deflector may not move freely on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica M525 F50 Surgical Microscope
The Issue: Leica Microsystems evaluated data showing that a malfunction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-Flow ON-Q Pain Relief System
The Issue: I-Flow initiated two voluntary product removals of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-Flow ON-Q Pain Relief System
The Issue: I-Flow initiated two voluntary product removals of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex XE-2100C Automated Hematology System
The Issue: There is a variation of reticulocyte counts between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex XE-5000 Automated Hematology System
The Issue: There is a variation of reticulocyte counts between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sysmex XE-2100 Automated Hematology System
The Issue: There is a variation of reticulocyte counts between
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CIDEX OPA
The Issue: The recall was initiated because Advanced Sterilization Products
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips
The Issue: Firm officials reported to CIN-DO that for this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayonet Forceps 7.75" (196.9 mm) 0.5 mm Tips Non-Stick Electrosurgical/Bipolar
The Issue: Firm officials reported to CIN-DO that their Bipolar
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips
The Issue: Firm officials reported to CIN-DO that for this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips...
The Issue: Firm officials reported to CIN-DO that their Electrosurgical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips
The Issue: Firm officials reported to CIN-DO that the outer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips
The Issue: Firm officials reported to CIN-DO that for this
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T5 Hytrel Zipper Toga. Product Usage: The togas are intended
The Issue: The clear tape, that is intended to aid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T4-Hytrel Zipper Toga Product Usage - The togas are intended
The Issue: The clear tape, that is intended to aid
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Low Profile Abutment
The Issue: Biomet 3i conducted a recall on the device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universal Spinal System Lamina Hooks Synthes Medium TI Lamina Hook
The Issue: USS Lamina Hooks, Medium, Right are being recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 ft
The Issue: A complaint was received, and later verified, that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT CA 19-9XR Reagent Kit
The Issue: The six ARCHITECT CA 19-9XR reagent lots are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.