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 29801–29820 of 38,428 recalls
Recalled Item: ADVIA Chemistry Acetaminophen reagents
The Issue: A change in the concentration of N-acetylcysteine (NAC)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis zee/ zeego systems
The Issue: in case a system error occurs and the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PathoDx Strep Grouping Kit
The Issue: A reagent present may produce weak or slow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PSW 1203.U/1
The Issue: Ventricular packing: LV software programming versions for BIOTRONIK
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PathoDx Strep B Grouping Latex
The Issue: A reagent present may produce weak or slow
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Enterococcus Screen Agar QUAD Plate
The Issue: The affected expired lots of product may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vancomycin Screen Agar
The Issue: The affected expired lots of product may have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter HomeChoice and HomeChoice Pro APD systems
The Issue: Loud operating sounds, which was unacceptable to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReSolve Locking Drainage Catheters The ReSolve Locking Catheters are intended
The Issue: Merit Medical Systems, Inc. is voluntarily conducting a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens Artis zee systems
The Issue: The possibility exists for a large amount of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Q systems
The Issue: The possibility exists for a large amount of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Axiom Artis systems
The Issue: The possibility exists for a large amount of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON S Family ultrasound systems utilizing the 18L6 HD and/or
The Issue: When using the CIVCO biopsy attachments in combination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring
The Issue: missing segments on the display that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OxiMax N-65 Handheld Pulse Oximeter. N65
The Issue: missing segments on the display that can
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: e.cam Gamma Camera
The Issue: failure mode related to the radial brake,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge 86 Series Washer/Disinfector with G1 control system software
The Issue: Getinge Disinfection AB has initiated a Field Correction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardy Diagnostics VRE Broth
The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardy Diagnostics BEA Agar with VGA container type: 15x100mm monoplate
The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hardy Diagnostics BHI with CIPRO
The Issue: Hardy Diagnostics is recalling MacConkey Agar with Ciprofloxacin,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.