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 25821–25840 of 38,428 recalls
Recalled Item: Titan Gel Serum Protein Control: SPE Control Cat. No 5136 1 x 2.0 mL
The Issue: Due to customer-experienced complaints on narrow assay range
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Precision Specimen Container- 4 oz (118 mL)
The Issue: Sterility of the outer surface of the container
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OMNIBotics Tracker Kit -Model: RM-10000 The TOTAL KNEE SURGETICS Navigation
The Issue: Incorrect lot number on outer kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ReShape Integrated Dual Balloon System
The Issue: ReShape Medical is recalling the Integrated Dual Balloon
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PerkinElmer 20ul Clear RoboRack Tip
The Issue: Defective tips have the potential to pipette/dispense volumes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Totalis
The Issue: Labeling: Statement was added to the Warnings/Precautions section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BARD INLAY Ureteral Stent with Suture
The Issue: Labeling: Statement was added to the Warnings/Precautions section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance iCT Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Brilliance ICT SP Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IQon Spectral CT Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Fluoro-4 Silicone Ureteral Stent
The Issue: Labeling: Statement was added to the Warnings/Precautions section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity Core 128 Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ingenuity CT Computed Tomography X-ray system
The Issue: The product label does not include the correct
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Inlay Optima¿ Multi-Length Ureteral Stent Coated Double Pigtail Ureteral
The Issue: Labeling: Statement was added to the Warnings/Precautions section
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Algerbrush-II Product Usage: Medical - For surgeons to use in
The Issue: According to firm ( Bausch & Lomb, Inc
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Powder Free Vinyl Exam Gloves Catalog numbers 14-116
The Issue: A container of McKesson vinyl gloves that failed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING...
The Issue: SKYLINE Variable Ti screws may have contained SKYLINE
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.