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 19321–19340 of 38,428 recalls
Recalled Item: EDS Light Suspension
The Issue: There is a potential the joint in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Raindrop Near Vision Inlay
The Issue: During a post approval study the firm found
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VITEK¿ 2 Systems Software Version 9.01 Update Kit.
The Issue: The VITEK¿ 2 Systems Software Version 9.01 software
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation 3.5
The Issue: Isocenter shifts when using dose tracking in RayStation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Empower FastLoad CT Syringe Pack -sterile disposable syringe kit for
The Issue: Insufficient seal on the sterile barrier of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEKIA Model 872 Single Piece Hydrophilic Acrylic Intraocular Lenses
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AutoMate 1250
The Issue: Beckman Coulter has identified a case where a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Perfusion Pack
The Issue: 4-way stopcocks and stopcock manifold assembled in certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centricity Universal Viewer Zero Footprint Client
The Issue: Issue #1 affects Software Versions 6.0 SP7, SP7.0.1,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SAPPHIRE Epidural Set Yellow-Striped Microbore
The Issue: There have been reports of distal occlusion alarms
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bucky Stand SU-4000 Input 2017.11.17. SU41711085 Date: 2017-11-17
The Issue: Unintentional U-Arm movement
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Volcano FFR software used in the following systems connected
The Issue: Interoperability issue that affects certain systems that use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Singles carbides by Meisinger
The Issue: Incorrect packaging; There is a potential that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Stationary Fluoroscopic X-ray System CombiDiagnost R90
The Issue: kV/mA lockin not functioning as specified which may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS T2X table
The Issue: Table may drift in the roll position while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS ORT 300
The Issue: Table may drift in the roll position while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS ORT 100 table
The Issue: Table may drift in the roll position while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMRIS ORT 200
The Issue: Table may drift in the roll position while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Binding Site Human IgM Kit (for SPAPLUS)
The Issue: Firm is offering advice to customers experiencing challenges
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 8Fr SAFE GRAD CAT W/Valve (Argyle Suction Catheter Kits with Chimney Valve)
The Issue: The product was released into commercial distribution while
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.