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 10961–10980 of 38,428 recalls
Recalled Item: ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part
The Issue: Updated and revised user instructions issued 7/14/22. Potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Identity Posterior Stabilised (PS) Knee Replacement System Model Number:
The Issue: Incorrect tibial base plate implant packaged in kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Illumina NextSeq 550Dx
The Issue: There is a potential that the DNA sequence
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model:
The Issue: Non-intended glue from the hub/shaft bond on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empower Introducer Sheath with Hydrophilic Coating 21F x 56cm Model:
The Issue: Non-intended glue from the hub/shaft bond on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
The Issue: Due to failure of microbial testing for total
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Liko Universal Twinbar 670 QRH
The Issue: An incorrect center bolt was used in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene...
The Issue: Transport company failed to stop at the border
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NeuMoDx Cartridge-For in vitro diagnostic use with NeuMoOx Molecular Systems
The Issue: for false positive results for SARS-CoV-2 in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORAcollect RNA: ORE-100
The Issue: Evaporation of stabilizing liquid reducing shelf life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ORAcollect Dx
The Issue: Evaporation of stabilizing liquid reducing shelf life
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
The Issue: There is potential for the images to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA Excite 3T. Magnetic Resonance Imaging System
The Issue: There is potential for the images to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5T SIGNA Excite HD
The Issue: There is potential for the images to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1.5T and 3.0T SIGNA HDx
The Issue: There is potential for the images to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiohelp-i Transport Guard with Transport Guard (701072525): is a blood
The Issue: for a loose cylindrical pin on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medical Device products purchased from Family Dollar retail stores located
The Issue: exposure to rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trumpf Mount Clamp Assembly (table adapter component)
The Issue: Reports have been received that after normal or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LIPOSORBER System
The Issue: Labeling change to due to the risk of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Beckman Coulter IRISpec CA/CB/CC control
The Issue: IRISpec CA failures for glucose
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.