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 17761–17780 of 38,428 recalls
Recalled Item: Centricity PACS Foundation Centricity PACS software product is intended for
The Issue: There is the possibility of viewing studies directly
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cepheid Xpert C. difficile/Epi Control Panel
The Issue: Product is labeled with expiration date of 2021-10-31,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 45cm Shaft PRODUCT CODE: NSLX145C
The Issue: Observed reported incidence rate for harm associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 37cm Shaft PRODUCT CODE: NSLX137C
The Issue: Observed reported incidence rate for harm associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ethicon ENSEAL X1 Curved Jaw Tissue Sealer 25cm Shaft PRODUCT CODE: NSLX125C
The Issue: Observed reported incidence rate for harm associated with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: InterStim(TM) System
The Issue: There is a potential for an unexpected increase
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IntraClude Intra-Aortic Occlusion Device
The Issue: Possibility of balloon rupture in intra-aortic occlusion devices
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer PSTTubes with LH (Lithium Heparin) Part/Catalog Number:365985
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer SST- Amber Part/Catalog Number: 365978
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer SST Part/Catalog No.365967
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer PST Tubewith LH (Lithium Heparin) - Amber Part/Catalog
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer Z (No Additive Tubes) Part/Catalog No.365963
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer Tubes with LH (Lithium Heparin) Part/Catalog No.365965
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Microtainer Tubes with FE (Sodium Fluoride / Disodium EDTA)
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD MicrotainerTubes with K2E (K2EDTA) Catalog Number: 365974
The Issue: Damaged reservoir may lead to a decreased fill
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cadence Science Pressure Control Glass Syringe
The Issue: The glass syringe used with Pressure Control Syringes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Centurion Convenience Kits
The Issue: This recall is a sub recall to BD
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Teleflex HUDSON RDI NEONATAL ConchaSmart Breathing Circuit with Dual Heated
The Issue: Reported complaints of cracks being observed, prior to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliA RF IgM Well
The Issue: for reporting low assay results
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG
The Issue: ECG trunk cables and leadwires may reduce the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.