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 19221–19240 of 38,428 recalls
Recalled Item: BARD SureStep Foley Tray System Bardex I.C. Complete Care Temperature
The Issue: Some SureStep" Foley Tray Systems with product catalog
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: I-View¿ Contrast Enhanced Digital Mammography
The Issue: Calibration issue not possible to visualize contrast uptake
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toothete Oral Care Sodium Bicarbonate Mouthpaste
The Issue: A voluntary recall of a lot (67924) of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Breast Milk Transfer Lid for use with Oral Syringe Connectors Model: 90003S-100
The Issue: The sterility may be compromised due to a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: UniCel DxC 660i
The Issue: When racks are front-loaded onto the sample presentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The UniCel DxI 600 and 800 Access Immunoassay Systems
The Issue: When racks are front-loaded onto the sample presentation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Equinoxe Preserve Humeral Stem
The Issue: Possibility that the Equinoxe Preserve Humeral Stem, 8mm,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Triton Sponge System (Software)
The Issue: Gauss Surgical is updating the Instructions for Use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Da Vinci Xi/X EndoWrist Monopolar Curved scissors (MCS)
The Issue: This recall is being initiated because lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox CALCIUM (Ca) Colorimetric Method RX Series Cat. No. CA 3871
The Issue: Update to the carryover avoidance technical bulletin to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Randox CALCIUM (Ca) COLORIMETRIC METHOD RX DAYTONA PLUS Cat. No. CA 8309 R1
The Issue: Update to the carryover avoidance technical bulletin to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiMobile UHMWPE Liner: ID-28mm/OD-54mm
The Issue: The internal labeling included with these implants may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BiMobile UHMWPE Liner: ID-28mm/OD-50mm
The Issue: The internal labeling included with these implants may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DX-D 600 DIRECT RADIOGRAPHY SYSTEM Product Usage: The DX-D 600
The Issue: After an upgrade of the software of the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MOSAIQ Oncology Information System Version 2.64. MOSAIQ is an oncology
The Issue: If a Setup field (CT, kV, MV or
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical C2 CryoBalloon Standard Focal Catheter
The Issue: Incorrect default dose and dose increments may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical C2 CryoBalloon Pear Focal Catheter
The Issue: Incorrect default dose and dose increments may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Pentax Medical C2 CryoBalloon Standard 90 degree Catheter
The Issue: Incorrect default dose and dose increments may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal CR Total Knee Replacement System
The Issue: The kits were prepared with incorrect patient ID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fructosamine Control 3
The Issue: The firm is conducting a Device Modification for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.