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 13961–13980 of 38,428 recalls
Recalled Item: TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch-
The Issue: Updated IFU to inlclude: (1) identify the risks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TyTek PneumoDart- Intended for introduction into the body to facilitate
The Issue: Updated IFU to inlclude: (1) identify the risks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge
The Issue: Updated IFU to inlclude: (1) identify the risks
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EL-Anti-SARS-CoV-2 IgG Kit
The Issue: The cross-reactivity of the device may present an
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD" Multi-Check CD4 Low Control 2.5 mL IVD - Product
The Issue: Recent product complaints showing an unexpected cell population
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDRAD Stellant FLEX Syringe Kits Common Name: Angiographic
The Issue: Specific lots of MEDRAD Stellant FLEX 150 mL
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elastic Traction Device
The Issue: FDA has informed Micro-Tech that the Elastic Traction
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK(TM)
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: QC Sets and Panels: KWIK-STIK" 2 Pack. Common Name: QC
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYFO DISK(TM)
The Issue: E. coli Contamination
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EDI Novel Coronavirus COVID-19 IgG ELISA Kit
The Issue: The use of deionized water rather than distilled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Quidel Triage BNP Calibrators
The Issue: Product compromised during shipment
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Conquest PTA Balloon dilation Catheter
The Issue: Dilation catheter packaged with the wrong size balloon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS¿ Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product...
The Issue: Elevated sample results signal/cutoff (s/c) values when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage:...
The Issue: Elevated sample results signal/cutoff (s/c) values when using
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COAPTITE Injectable Implant
The Issue: The Instructions for Use (IFU) updated 03/02/2020 does
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: XTANT Medical
The Issue: Cervical Implants contain a label that incorrectly identifies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Blood Monitoring Unit (BMU 40)
The Issue: The Printed Circuit Board Assembly (PCBA) are not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BladderScan Prime Plus Probe - Product Usage: intended
The Issue: Due to a change in handle material and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: v|tome|x L Series non-destructive testing cabinet x-ray systems
The Issue: It was discovered during testing of the v/tome/x
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.