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 10721–10740 of 38,428 recalls
Recalled Item: Evans Wedge Disposable Trials
The Issue: During re-work of disposable instruments to relabel for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-Sterile Double Ended Trial Kit
The Issue: Product labeled incorrectly. The lot was labeled with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Evans Wedge Disposable Trials
The Issue: During re-work of disposable instruments to relabel for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The device is a whole-body CT x-ray system. The acquired
The Issue: Three software issues affecting incorrect image display, error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK 2 Systems and VITEK 2 with MYLA.
The Issue: Software issue where results sent to the LIS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MedMinder Medication Dispenser- Intended to serve as a medication reminder
The Issue: Discontinuation of the Emergency Alert watch or pendant
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Smart Toe II Intramedullary Arthrodesis Implant
The Issue: The nickel-sensitivity statement on the outer carton may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific
The Issue: Anti-Kappa APC & Anti-Kappa PE analyte reagents may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Anti-Kappa APC (Cat. No. 341098) is an analyte specific
The Issue: Anti-Kappa APC & Anti-Kappa PE analyte reagents may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT
The Issue: The device was not cleared for U.S. distribution
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
The Issue: Falsely high or delayed patient and QC results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
The Issue: Falsely high or delayed patient and QC results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
The Issue: Falsely high or delayed patient and QC results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CK MB Calibrator
The Issue: Randox have realigned CK-MB Calibrator, CK2393, lot number
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Olympus Uretero-reno videoscope
The Issue: The bending section of the URF-V2 may crack,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: K-Wire
The Issue: Products do not meet length and diameter specifications
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 980 Series Ventilator
The Issue: The audible alarm may not sound and/or the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1
The Issue: Affected product lots may contain the incorrect needle
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inactivated macrolide and quinolone-resistant Mycoplasma genitalium
The Issue: QC process was not adequate for the specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott SE TactiCath Sensor Enabled Contact Force Ablation Catheter
The Issue: Devices were manufactured with a "First Use Date"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.