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 25021–25040 of 38,428 recalls
Recalled Item: Atrium PVC 8 Fr Straight Thoracic Catheter Code Number: 8008
The Issue: Labeling icon depicts a catheter having six (6)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Integra Cadence Total Ankle System
The Issue: Posterior tibial fractures have been reported
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atrium PVC 10 Fr Straight Thoracic Catheter Code Number: 8010
The Issue: Labeling icon depicts a catheter having six (6)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Discovery MR450 The systems are whole body magnetic resonance scanners
The Issue: safety issue with the patient bore heating
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT 12 inch Right Angle Feeding Set with Y-Port Used
The Issue: Expired expiration dates are listed on the pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AMT Bridle - Nasal Tube Retaining System Used with Nasogastric/Nasointestinal
The Issue: Expired expiration dates are listed on the pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates
The Issue: The 6-hole Pubic Symphysis plate (PN 70-0451) is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT X-Ray
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity CT X-Ray
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity Core128 X-Ray
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Ingenuity Core X-Ray
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance 64 System
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips Healthcare Brilliance iCT SP X-Ray
The Issue: During a bolus tracking procedure, no images were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Radiation Therapy Treatment Planning System
The Issue: An error in NVIDIA GPU (Graphics Processing Unit)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ETEST XM256 (Cefuroxime)
The Issue: performance issues. False Susceptible result instead of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HARVEST NEEDLE 15GA X 2 Intended for the purpose of
The Issue: The recalling firm received a complaint from one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: T-LOK BONE MARROW BIOPSY NEEDLE 8G x 4 EXT CAN
The Issue: The recalling firm received a complaint from one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BONE MARROW ASPIRATION NEEDLE 15G x 2.688 MAX and 15G
The Issue: The recalling firm received a complaint from one
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECMO Reinforced Dual Lumen Cannula
The Issue: Clamping the clear tube very close to the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.