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 38041–38060 of 38,428 recalls
Recalled Item: UniCel DxH Slidemaker Stainer Stainer Floor Cabinet
The Issue: The recall was initiated because Beckman Coulter has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vector TAS Modular Driver
The Issue: The Instructions For Use (IFUs) for Vector TAS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Progressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm)
The Issue: Some of the sterile packages had broken seals
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain Slide Processor. The PrepStain System is a liquid-based thin
The Issue: Some Prep Stain Kit, 1.2 DiTi Cones have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain Kit: 1.2 DiTi Cone. The PrepStain System is a
The Issue: Some Prep Stain Kit, 1.2 DiTi Cones have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain Upgrade Kit: 1.3.0.3/1.2 DiTi Cone. The PrepStain System is
The Issue: Some Prep Stain Kit, 1.2 DiTi Cones have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PrepStain PM Kit
The Issue: Some Prep Stain Kit, 1.2 DiTi Cones have
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory Versions 6.4 and later using Microbiology Result Entry
The Issue: The recall was initiated because Sunquest has confirmed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TSX-IOI: AQUILION 32/64
The Issue: The firm initiated this recall due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RX Accunet Embolic Protection System Common Name: RX
The Issue: The recall was initiated because Abbot Vascular has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY GE 3.0T SIGNA
The Issue: Screen save images are included in wrong exam
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Freedom Cordless LED Light System. Freedom System
The Issue: The firm recalled the Freedom Cordless LED Headlight
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory : intended for use by professionals working in
The Issue: Online calculations may not be performed as expected
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Endoscopic retrieval device. The disposable Raptor grasping device in intended
The Issue: When the outer catheter is either coiled or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for
The Issue: A voluntary recall is initiated for ZYMUTEST HIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay
The Issue: A voluntary recall is initiated for ZYMUTEST HIA
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Implant
The Issue: On November 3, 2011 Biomet 3i, Palm Beach
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sunquest Laboratory
The Issue: Sunquest is recalling Sunquest Laboratory version 7.0 because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fusion Workstation.
The Issue: After a period of time running Fusion Workstation,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.7U163CS-36 In combination with below systems MUX-100H
The Issue: Shimadzu is recalling Diagnostic X-ray Beam-Limiting Device, Mobile
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.