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 23701–23720 of 38,428 recalls
Recalled Item: Vis-U-All High Temp 10.5"x28" Self Seal Pouch 100 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 8"x16" Self Seal Pouch 200 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temperature Tubing 4"x100'. One roll per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temp 5.5"x10" Self Seal Pouch 200 pouches per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vis-U-All High Temperature Tubing 14"x100'. One roll per box
The Issue: On June 15, 2017, STERIS identified that the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PriMatrix¿ is an acellular dermal tissue matrix derived from fetal
The Issue: During Final Assembly Operation, it was noticed that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FUJIFILM FDR Visionary Suite with CH-200. Model # CH-200
The Issue: A potential issue in the X-ray tube ceiling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Various custom surgical kits manufactured for CMS
The Issue: The firm manufactured and distributed custom surgical kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Encore(TM) 26 Inflation Device
The Issue: Boston Scientific (BSC) has received complaints for cracked
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum 360 Infusion System
The Issue: for the Connectivity Engine Module of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SMARTABLATE RF System Generator
The Issue: Generator may inadvertently deliver RF energy if the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: mcompass 2-channel Balloon Catheters The mcompass Biofeedback Anorectal...
The Issue: failure in the balloon bond in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ArjoHuntleigh Flowtron ACS900
The Issue: Reports of the device failure involving delivering continuous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile
The Issue: Presence of loose polypropylene foreign matter above release
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy¿ AspireHC¿ Generator
The Issue: Manufacturing process used to assemble the circuit board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy¿ AspireHC¿ Generator
The Issue: Manufacturing process used to assemble the circuit board
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Eye Care PACS Viewer 5.2 Merge Eye Care PACS
The Issue: When the user has not set up any
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Aviva II Meter - Product Usage: a. The Accu-Chek
The Issue: Meters may contain a damaged C29 capacitor resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Accu-Chek Performa II Meter - Product Usage: a. The Accu-Chek
The Issue: Meters may contain a damaged C29 capacitor resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DRILL BIT MINI QUICK CONNECT 1.0MM
The Issue: A raw material anomaly was discovered in four
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.