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 23241–23260 of 38,428 recalls
Recalled Item: BD MAX" CT/GC/TV. Catalog Number(s): 443824
The Issue: BD recently notified customers in July 2017 regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAXTM Vaginal Panel. Catalog Number(s): 443712 443710 443711 (RUO)for
The Issue: BD recently notified customers in July 2017 regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MAX" UVE Specimen Collection Kit. Catalog Number(s): 443376 for
The Issue: BD recently notified customers in July 2017 regarding
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Elastic Esmark Bandage
The Issue: Product did not undergo correct sterilization procedures and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AirLife(TM) Reduced Heparin ARTERIAL BLOOD SAMPLER
The Issue: Lot #0001047501 of the 9025RHTR ABG sampling kits
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Vistec" X-Ray Detectable Sponges
The Issue: Medtronic is voluntarily recalling two production lots of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ECG Out Cable - Heartstart MRx M1783A/M5526A 12-pin Sync cables
The Issue: Issue with ECG out cables. When a Philips
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation Product Usage: is a software system designed for treatment
The Issue: For the proton QA preparation module in RayStation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 100 Intra-Aortic Balloon Pump. It supports the heart's left
The Issue: False blood back detection alarm and the ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 100i Intra-Aortic Balloon Pump. It supports the heart's left
The Issue: False blood back detection alarm and the ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS 300 Intra-Aortic Balloon Pump. It supports the heart's left
The Issue: False blood back detection alarm and the ingress
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-Series A7 Anesthesia Delivery System
The Issue: A software issue may result in the previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-Series A3/A5 Anesthesia Delivery System
The Issue: A software issue may result in the previous
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PC-1000
The Issue: The lift motor used to raise and lower
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TD60 Transmitter battery charger used with the BeneVision Central Station
The Issue: A damaged circuit board in the battery charger
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyCareLink Smart Patient Monitors. It is intended for use with
The Issue: Patients monitored on two (2) or more implanted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MyCareLink Patient Monitors. It is intended for used with a
The Issue: Patients monitored on two (2) or more implanted
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ASPIRE Cristalle (FDR MS-3500) Mammography machine The Fujifilm Digital...
The Issue: There was a case that the swivel arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aspire HD Plus (FDR MS-2500)
The Issue: There was a case that the swivel arm
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mobile Detector Holder - Stationary X-ray System (RF System). suitable
The Issue: If the lock mechanism of the movable camp
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.