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 1501–1520 of 38,428 recalls
Recalled Item: FLEX Monoclonal Mouse Anti-Human CD20cy
The Issue: Their is the potential for weak staining which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number:...
The Issue: for falsely depressed patient, quality control (QC),
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merge Hemo
The Issue: Merge Healthcare has been informed by Schiller AG
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%
The Issue: Blood collection tubes were manufactured with the label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Medline Convenience Kits: 1) MAJOR PACK L-F
The Issue: Convenience kits labeled as sterile have not gone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Argus PB-3000
The Issue: Vital sign monitoring instrument may trigger an error
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sterile Medline Convenience Kits: 1) EXTREMITY PACK
The Issue: Convenience kits labeled as sterile have not gone
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baster Continu-Flo Solution Set
The Issue: Baxter Healthcare Corporation is issuing an Urgent Medical
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntelliSpace Cardiovascular
The Issue: Software issue that results in the display of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 11B
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 8B
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 11A
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 9B
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 6 Service
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 10B
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 12A
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 7
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayStation with the following product descriptions: 1. RayStation 2023B
The Issue: DICOM SOP Instance UID and Series Instance UID
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: FloPatch FP120
The Issue: Flowmeter patch as a human readable expiry date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158
The Issue: As a result of Post-Market half-time stability testing,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.