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 11821–11840 of 38,428 recalls
Recalled Item: REGARD Newborn Tray
The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REGARD Core Biopsy Tray
The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REGARD Ultrasound Tray
The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: REGARD Stereotactic Tray
The Issue: Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PUMP SET
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Pump Measured Volume Solution Set/ w/ Auto Shut-Off. Single-use
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 15 drops/ml
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Pump Primary Administration Set w/ micro Tubing for Epidural
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.-single use
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OUTLOOK PUMP IV SET W/UNIVERSAL SPIKE-single-use for use with the
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Y-Type Blood
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 60 drops/ml
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Pump Blood Administration Set with SAFELINE Injection Site-single use
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ET82HP OUTLOOK PUMP EXTENSION SET-single-use for use with the Outlook
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 10 drops/ml
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: V1500HP OUTLOOK PUMP SET 118-single-use for use with the Outlook
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OUTLOOK PUMP IV SET
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Pump Add-On Set-single use
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OUTLOOK PUMP SET
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook¿ Pump 15 Drop 0.2 Micron Filtered IV Set with
The Issue: Leakage of the pump set within the cassette
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.