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 17501–17520 of 38,428 recalls
Recalled Item: CS100 Intra-Aortic Balloon Pump
The Issue: If battery maintenance is not performed appropriately, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS300 Intra-Aortic Balloon Pump
The Issue: If battery maintenance is not performed per instructions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP)
The Issue: Battery short-run times and unanticipated stoppage may be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CS300 Intra-Aortic Balloon Pump
The Issue: If battery maintenance is not performed per instructions,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cardiosave Rescue IABP
The Issue: If battery maintenance is not performed appropriately, the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM¿ XK Long-Term Hemodialysis Catheter....
The Issue: Incorrect Peel-Apart Introducer Sheath in Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EQUISTREAM¿ XK Long-Term Hemodialysis Catheter....
The Issue: Incorrect Peel-Apart Introducer Sheath in Kit
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691
The Issue: Device vented gas below the stated pressure
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
The Issue: Capiox NX19 Oxygenator may contain a non-functioning arterial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to
The Issue: Capiox NX19 Oxygenator may contain a non-functioning arterial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acuject Variable Injection Needle
The Issue: for occluded injection needles
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
The Issue: Capiox NX19 Oxygenator may contain a non-functioning arterial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Terumo Capiox NX19 Oxygenator (East Orientation)
The Issue: Capiox NX19 Oxygenator may contain a non-functioning arterial
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: STANLEY Healthcare Arial 54315 Network Manager
The Issue: STANLEY Healthcare has received reports of outages on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advincula Delineator with Ultem Plastic Soft Cup size 3.0 cm
The Issue: The soft, flexible cup of the Advincula Delineator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Advincula Delineator with Ultem Plastic Soft Cup size 2.5 cm
The Issue: The soft, flexible cup of the Advincula Delineator
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: A-CIFT SoloFuse Fixed Angle Driver
The Issue: There is a potential for the driver to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SYNCHRON Systems Barbiturates Reagent (BARB 1 X 250)
The Issue: The firm has identified that cross-reactivity testing may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer Lithium HeparinN (LH) 95 USP Units Blood Collection Tubes
The Issue: False elevation of carboxyhemoglobin (COHb) results have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD Vacutainer PST Gel and Lithium HeparinN (LH) 56 Units Blood Collection Tubes
The Issue: False elevation of carboxyhemoglobin (COHb) results have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.