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 37941–37960 of 38,428 recalls
Recalled Item: STERRAD 200 System Carriage
The Issue: Advanced Sterilization Products (ASP) is recalling the STERRAD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DePuy Mitek VAPR Hook Electrode 3.5mm Hook Electrode with Integrated
The Issue: Product may have wrong large product identification label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Poly stat Flu A & B Test Manufactured for Polymedco
The Issue: There have been reports of dual positive (Flu
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Status Flu A + B Test Manufactured by Princeton Bio
The Issue: There have been reports of dual positive (Flu
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies
The Issue: There have been reports of dual positive (Flu
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BLOM-SINGER indwelling TEP Occluder
The Issue: Helix Medical LLC is recalling the BLOM-SINGER indwelling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle Hip Solutions ALTRX Polyethylene Acetabular Liner
The Issue: DePuy Orthopaedics, Inc. (DePuy) is issuing a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-STAT cTnI cartridges Product Usage: The i-STAT cTnl test is
The Issue: Abbott Point of Care has determined that i-Stat
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: S4 Cervical (S4C) Revision Instruments (FW099R and FW101R). The S4C
The Issue: Aesculap Implant Systems, LLC has initiated a voluntary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE Healthcare Quasar Nuclear Medicine System
The Issue: Accelerated fatigue of the lateral axis motion subsystem
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PST Gel and Lithium Heparin (LH)
The Issue: BD is conducting a recall of the BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-STAT PT/INR cartridge Abbott Point of Care Inc. Abbott Park
The Issue: The i-STAT PT/INR cartridges have the potential to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Presage ST2 Assay
The Issue: The recall was initiated because Critical Diagnostics has
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lithium Thionyl non-rechargeable disposable battery pack P/N 350-0294-01...
The Issue: Braemar has recently became aware of a battery
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas KRAS Mutation Test for In Vitro Diagnostic Use Product
The Issue: During the real-time stability testing for the cobas
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Siemens syngo.plaza. Radiological image processing system
The Issue: Siemens became aware of a potential malfunction when
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Thyroglobulin Antibody (TgAB) Calibrator - Product Usage: intended for IN
The Issue: Some combinations of Calibrator lots and AlA PACKS
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Timberline Cranial Caudal and Posterior Blades
The Issue: Biomet Spine, LLC is recalling the Timberline Cranial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal
The Issue: Two reasons for recall. 1. Incorrect pressure relief
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The brand name of the device is AlgiNot
The Issue: The firm recalled the product because it may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.