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 10861–10880 of 38,428 recalls
Recalled Item: Philips Respironics V60 Plus Ventilator (All Models
The Issue: Ventilator units have an issue impacting an internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Respironics V60 Ventilator (All Models
The Issue: Ventilator units have an issue impacting an internal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Regard IV Start Kit for preparing and/or dressing a peripheral
The Issue: A kit component, the PDI Prevantics Swab, was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Universal Flexible Arm part number
The Issue: Excess force used to tighten the Universal Flexible
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DigitalDiagnost C50 1.1
The Issue: Following a system restart where the Table Height
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: syngo Application software VE20 (Material Number 10848815) installed on the
The Issue: After CT image data from Toshiba is loaded,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono floor in combination with a Siemens Healthineers table
The Issue: Five potential software issues affecting Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen KRAS RGQ PCR Kit (24) Model Number(s): (US IVD)
The Issue: False positive or false negative G12C (12CYS) mutation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis icono biplane- in combination with a Siemens Healthineers table
The Issue: Five potential software issues affecting Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis pheno- in combination with a Siemens Healthineers table or
The Issue: Five potential software issues affecting Artis pheno and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: therascreen KRAS RGQ PCR Kit (24) (Japan IVD
The Issue: False positive or false negative G12C (12CYS) mutation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter DISCPAC Syringe Tip Caps
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Anterior Hip Pack - Surgical Kit
The Issue: The outer bag may be perforated or torn,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coryell Memorial Hosp Total
The Issue: The outer bag may be perforated or torn,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Surgicare Neuro Pack - Neurological Kit
The Issue: The outer bag may be perforated or torn,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Total Knee Pack - Surgical Kit
The Issue: The outer bag may be perforated or torn,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lum Lam Custom Pack - Anesthesia Kit
The Issue: The outer bag may be perforated or torn,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S
The Issue: Devices distributed lacked regulatory clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mycoplasma genitalium Control Panel (Inactivated Pellet)
The Issue: Distributed product did not undergo proper release testing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celltrion DiaTrust COVID-19 Ag Rapid Test
The Issue: Kits were labeled with incorrect expiration dates
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.