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 35201–35220 of 38,428 recalls
Recalled Item: Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advanta SST Grafts >or= 6mm Intended for use in arterial
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Flixene IFG Vascular Grafts >or= 6mm Intended for use in
The Issue: Inner tray label may adhere to wall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vector TAS 8mm Screw. The Device Listing Number
The Issue: Ormco Corporation is voluntarily recalling one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OLA Buffer For Laboratory Use
The Issue: The package insert for FG OLA Buffer, GPR
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IsoGel AIR 84
The Issue: Complaints were received from the field indicating that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AperFix AM Femoral Implant
The Issue: for AperFix 24 mm implant breaking inside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LPS Lower Extremity Dovetail Intercalary component. Intended for use in
The Issue: The LPS Lower Extremity Dovetail Intercalary component has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe
The Issue: Visible orange/ brown particulate on the needles of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe
The Issue: Visible orange/ brown particulate on the needles of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe
The Issue: Visible orange/ brown particulate on the needles of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe
The Issue: Visible orange/ brown particulate on the needles of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Jelco Smiths Medical Hypodermic Needle-Pro¿ Fixed Needle Insulin Syringe
The Issue: Visible orange/ brown particulate on the needles of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acuson SC2000 volume imaging ultrasound systems at software version 3.0.
The Issue: Software issue results in inaccurate 3D image may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tempa DOT Single-Use Clinical Thermometer Medical Indicators Made in U.S.A.
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm
The Issue: The Lancet will not retract after activation thus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Non-sterile Viscot Surgical Skin Markers Part Number 1437-100 Non-sterile Viscot
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Rultract Retractor Ratchet Cover Plate Distributed by Pemco
The Issue: The firm became aware of the problem when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Tray Surgical
The Issue: The firm will recall and replace the identified
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.