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 9961–9980 of 38,428 recalls
Recalled Item: Iso-Gard Filter S with Expandi-Flex/Elbow: a)
The Issue: Incidents of device splitting or detaching during use
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSSUR Power Knee OSSUR Power Knee
The Issue: Battery may dislodge from the Power Knee
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Surgical Operating Microscopes
The Issue: During internal testing, Leica Microsystems has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Surgical Operating Microscopes
The Issue: During internal testing, Leica Microsystems has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Surgical Operating Microscopes
The Issue: During internal testing, Leica Microsystems has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica Surgical Operating Microscopes
The Issue: During internal testing, Leica Microsystems has become aware
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips BiPAP A30
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips BiPAP V30 Auto
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips OmniLab Advanced+ Intl (Flow Gen)
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips OmniLab Advanced + with Heated Tube Humidifier
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips BiPAP A40
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Philips OmniLab Advanced+
The Issue: Motor assemblies manufactured with nonconforming plastic that contributes
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: G7 Acetabular System
The Issue: The outer sterile package cavity has a corner
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent...
The Issue: Dimension Vista¿ High Density Lipoprotein Cholesterol (HDLC) Potential
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Short tibial bearing MK4 - Std
The Issue: A MK4 Tibial Bearing was supplied with the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: sentec 24 / MARe-SF Multi-Site Attachment Ring Easy
The Issue: Weak skin adhesion
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MED-RX UROLOGICAL CYSTO/BLADDER IRRIGATION SET
The Issue: Some of the labels of the kits for
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Puritan Bennett 560 Ventilator
The Issue: Medtronic has confirmed six reports from customers outside
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Abbott Alinity m SARS-CoV-2 CTRL Kit
The Issue: Reports received of an increase of message code
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number...
The Issue: Dimension Magnesium (MG) Flex reagent cartridge lots may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.