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 5141–5160 of 38,428 recalls
Recalled Item: TabloCart with Prefiltration Drawer PN-0006813
The Issue: A cart with prefiltration drawer, an optional hemodialysis
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE STERILE IRIS SCISSORS CVD/STD (case) and DYNJ04049H
The Issue: There is the potential of the tip protector
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Decompression Table Model E9011. This device applies cervical and/or lumbar
The Issue: This product is being recalled due to potentially
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BSM-3000 Series Bedside Monitor The Life Scope BSM-3000
The Issue: Due to software issue the device may give
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow FiberOptix Intra-Aortic Balloon Catheter Kit: a)
The Issue: Teleflex received reports indicating an infrequent condition that,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow UltraFlex Intra-Aortic Balloon Catheter Kit
The Issue: Teleflex received reports indicating an infrequent condition that,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Core 15-inch FHD Model/Catalog Number: 0570-0437 Software
The Issue: Due to software issues, their is the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Arrow Ultra 8 IAB Intra-Aortic Balloon Catheter Kit
The Issue: Teleflex received reports indicating an infrequent condition that,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GlideScope Core 15-inch Monitor Model/Catalog Number: 0570-0404 Product
The Issue: Due to software issues, their is the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acumatch L-Series BIPOLAR LINER
The Issue: The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CDC
The Issue: The H5b component may fail to amplify, resulting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: O-arm O2 Imaging System-Mobile x-ray system designed for 2D fluoroscopic
The Issue: for an electrical component of the O-arm"
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EsoFLIP
The Issue: Due to saline conductivity issues, their is a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC-Intended for tightening
The Issue: Stardrive Screwdrivers manufactured without a 5-degree relief cut
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MNA-420 ENC HDMI
The Issue: We have identified a potential issue with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EasySuite 4K Integrated Operating Room System Model/Catalog Number:...
The Issue: A subset of the ES4K systems do not
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EsophaCap Product Name: EsophaCap (25mm diameter
The Issue: The EsophaCap sponge may be at increased risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EsophaCap Product Name: EsophaCap (20mm diameter
The Issue: The EsophaCap sponge may be at increased risk
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew OXINIUM Femoral Head 12/14 Taper
The Issue: Packaging contained the incorrect size of femoral head
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Coviden Monoject 60ml Syringe Luer-Lock Tip-used to inject fluid into
The Issue: Quarantined product was inadvertently distributed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.