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 33861–33880 of 38,428 recalls
Recalled Item: On-X Prosthetic Heart Valve with Gelweave Valsalva Graft
The Issue: Mix-up RGA (Return Goods Authorization) leading to 5
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL
The Issue: Abbott has confirmed that a performance shift in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle
The Issue: Abbott has confirmed that a performance shift in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CartoUnivu Module
The Issue: Biosense Webster has initiated a recall of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Synthes Hohmann Retractor
The Issue: The Synthes Hohmann Retractor was mis-etched on the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pinnacle3 Radiation Therapy Planning (RTP) System
The Issue: Philips Medical Systems have recently determined that a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS AST For the In vitro quantitative determination of AST
The Issue: Marketing the devices outside 510(k) requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS URIC ACID For the In vitro quantitative determination of
The Issue: Marketing the devices outside 510(k) requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMS BUN UREA NITROGEN For the In vitro quantitative determination
The Issue: Marketing the devices outside 510(k) requirements
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or
The Issue: Internal testing revealed a potentially defective component on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Thermedx Fluid Management System is designed to provide irrigation
The Issue: A vendor changed the manufacturing process of a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: bioMerieux PREVI Isola System (General purpose
The Issue: The firm has determined the product may fail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage:
The Issue: As the result of a complaint to Heraeus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SIGMA SPECTRUM Volumetric Infusion Pump with Master Drug Library Product
The Issue: Baxter Healthcare Corporation has issued an Urgent Device
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pega Medical Inc.
The Issue: The Male Components in this lot are made
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Artis Zee Angiographic x-ray systems.
The Issue: An inappropriate cable connection was assembled for certain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Draeger PS500 Power Supply Unit of the Infinity ACS Workstation
The Issue: The battery capacity of the optional PS500 Power
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: JMS
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AXIOM Artis Systems Product usage: Artis zee is a family
The Issue: Certain units of the AXIOM Artis Systems are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage:
The Issue: The lumen of the Medline Sterile Foley Catheter
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.