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 7481–7500 of 38,428 recalls
Recalled Item: Infinity 5 Implantable Pulse Generator Product Description: The
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Infinity 7 Implantable Pulse Generator Product Description: The
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim DRG Implantable Pulse Generator Product Description: The
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Proclaim Plus 7 Implantable Pulse Generator Product Description:
The Issue: Firm has received complaints from patients who are
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PORTEX 0.5u HYDROPHOBIC DISC FILTER
The Issue: Smiths Medical identified a labeling error in which
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aquilex Fluid Control System-Intended to provide fluid distension of the
The Issue: The display of inflow volume can reach its
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RayCare software
The Issue: An issue was found in Software RayCare 5A,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MobileLink Acetabular Cup System
The Issue: Product is labeled with incorrect offset
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L-Aneurysm Clip TITANIUM Paddle-Clip
The Issue: Wrong product coloring. The paddle clips should be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: L-Aneurysm Clip TITANIUM Paddle-Clip
The Issue: Wrong product coloring. The paddle clips should be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Q2 Multiport Extension set
The Issue: For administration of intravenous fluids to a patient
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: COPAN 300uL Transfer Pipette Individually wrapped pipettes
The Issue: Due to plastic defects, the pipette aspiration capability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Embrace2- Indicated for use as an adjunct to seizure monitoring
The Issue: May have a battery life lasting less than
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACL TOP Family 50 Series Models as follows: In vitro
The Issue: Sample misidentification could occur under specific conditions and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ACUSON Redwood 2.0 ultrasound systems
The Issue: If a user-generated preset for an 18L6 transducer
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP DEBAKEY 35 MM JAW 5MM
The Issue: Specific lots of the product have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Chevalier Valvulotome is a device used to disrupt the
The Issue: Burrs (molding flash) on the cutter may tear
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snowden-Pencer MIS DIAMOND-TOUCH ATRAUMATIC GRASPER DIAMOND JAW 5MM
The Issue: Specific lots of the product have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Plum 360 Infusion System
The Issue: Due to a manufacturing defect of a supplier
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Snowden-Pencer MIS DIAMOND-TOUCH CLAMP BOWEL 50 MM JAW 5MM
The Issue: Specific lots of the product have the potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.