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 28541–28560 of 38,428 recalls
Recalled Item: Baxter
The Issue: All lots of RAPIDFILL Syringe Strips lack evidence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACIST Medical Systems
The Issue: Reports related to ingress of air into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fukuda Denshi patient monitor model DS-8100M and DS-8100N. The Fukuda
The Issue: A possible malfunction where a Short-term Battery Error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary
The Issue: Labeling error: Catalog contains Instructions for Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter
The Issue: Labeling error: Catalog contains Instructions for Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter
The Issue: Labeling error: Catalog contains Instructions for Use (IFU)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Assembly
The Issue: for the parts to crack
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil
The Issue: for higher than specified surface temperatures. Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stryker Aero-AL Impaction handle Catalog Number 48921007. Stryker Spine...
The Issue: Reported jamming of the impaction handle when assembled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mavig Monitor Suspension System
The Issue: GE Healthcare has recently become aware of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HemosIL Plasminogen
The Issue: This Lot is not meeting labeled on-board instrument
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fuse 1C Colonoscope
The Issue: The bending section of the device may partially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VNS Therapy AspireSR Generator Model 106. Indicated for use as
The Issue: Recall being initiated in response to three reports
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: arkray SPOTCHEM II Basic Panel - 1 Reagent test strips
The Issue: One lot each of SPOTCHEM II Basic PANEL-1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: arkray SPOTCHEM II Glucose Reagent test strips
The Issue: One lot each of SPOTCHEM II Basic PANEL-1
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Oncentra External Beam - VMAT - Radiation therapy planning system
The Issue: When using the option "Tumor Overlap Fraction" in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthrex IBalance TKA Tibial Tray Size 2 - Catalog # AR-503-TTTC
The Issue: Devices reported to have a smooth texture to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView are gamma cameras
The Issue: The firm discovered four issues with the BrightView
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView XCT & BrightView XCT Upgrade
The Issue: The firm discovered four issues with the BrightView
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BrightView X are gamma cameras
The Issue: The firm discovered four issues with the BrightView
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.