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 29861–29880 of 38,428 recalls
Recalled Item: Bone Marrow Aspiration Needle 15G x 2.688 MAX
The Issue: defect in the forming of the primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle 133 Series Tissue Expanders Product Usage: Natrelle 133 Series
The Issue: Allergan is recalling the NATRELLE 133 and CUI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Natrelle CUI Series Tissue Expanders. Product Usage: Natrelle CUI Series
The Issue: Allergan is recalling the NATRELLE 133 and CUI
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bond Elut OMS (Dried Matrix Spotting)' Product
The Issue: The product was marketed without 510(k) clearance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arthroscopic Energy 50¿ Probe with Suction
The Issue: Probe programming error. The incorrect program can generate
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mission -Breath Alcohol Detector -15 tests - 0.08% BAC -
The Issue: Acon Laboratories, Inc. is recalling Mission Breath Alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Invivo Expression MRI Patient Monitoring System.
The Issue: The device's labeling inaccurately indicates Endotracheal as a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
The Issue: Medium Bone Plate Forceps was assembled with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ZNN Antegrade Femoral Nail (ZNN AF). Orthopedic internal fixation device.
The Issue: A single distributed ZNN Greater Trochanter Femoral Nail
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Celsite Implantable Access Port System
The Issue: The manufacturer, B. Braun medical France, received endotoxin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYMMETRY SURGICAL DISPOSABLE TOWEL CLAMP
The Issue: Lack of sterility assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: INSTRUMENT ARM DRAPE
The Issue: Field Safety Notification to advise of an issue
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPD-Scan III Power/Corneal Analyzer Opthalmic Software versions 1.00.08 1.05.07
The Issue: Software bug was found where there was no
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: i-Stat PT/INR Cartridges List number 03P89-24 The cartridges are packaged
The Issue: Certain lots of PT/INR cartridges may generate a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mermaid Medical M-Biopsy Coaxial Introducer Needle
The Issue: Mermaid Medical A/S is recalling some of their
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sorin Stockert Heater-Cooler 3T
The Issue: colonization of organisms, including Mycobacteria, in Sorin
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.