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 9861–9880 of 38,428 recalls
Recalled Item: CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 4"
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS MID-LENGTH CONTAINER 19X12" (48.3 X 30.5CM) 5"
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 6"
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS LARGE
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS HALF-LENGTH CONTAINER 11X12" (27.9 X 30.5CM) 5"
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM)
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS FULL-LENGTH CONTAINER 23 X12" (58.4 X 30.5CM)
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS LARGE
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CareFusion V.Mueller GENESIS SMALL
The Issue: Genesis STERRAD Reusable Rigid Sterilization Containers have not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GaGa Pro Lighting Equipment Co. Ltd. manufactures Class IV Laser
The Issue: GAGA Pro LLS systems was not in compliance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LumiraDx SARS-CoV-2 Antigen (Ag) Liquid Quality Control Kit Catalog #:
The Issue: Assigned vial lot numbers for the incorrect type
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hamilton-C6
The Issue: Due to a malfunction related to the backlight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoPulse Li-ion Battery used on the AutoPulse Resuscitation System Model
The Issue: Due to increase in Li-Ion Battery failures
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: WEB Detachment Controller
The Issue: Detachment controller, of an aneurysm embolization system, has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GORE CARDIOFORM ASD Occluder. cardiovascular implant.
The Issue: Due to manufacturing records (Release Test Results) indicating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insulin Pump/Model: MiniMed 620G/ MMT-1750 MiniMed 640G/ MMT-1711
The Issue: Medtronic identified a cybersecurity vulnerability in the MiniMed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit
The Issue: Product may not be sterile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Insulin Pump/Model: MiniMed 630G/ MMT-1715
The Issue: Medtronic identified a cybersecurity vulnerability in the MiniMed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Simple Clamp
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Allen Standard Starburst
The Issue: the adhesive, applied to screws and bolts as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.