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 19021–19040 of 38,428 recalls
Recalled Item: Bentson PTFE Wire Guide
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Angled Tip Ureteral Catheter Set
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Heavy Duty PTFE Wire Guide
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Malecot Nephrostomy Set
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Percutaneous Pigtail Nephrostomy Set
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Universa Soft Ureteral Stent
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Sof-Flex Multi-Lenqth Ureteral Stent Set
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Fixed Core Straight Safety Wire Guide
The Issue: The wire guide may be incorrectly loaded into
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: King LTS-D Kit Size 1
The Issue: Size 0 products were incorrectly packaged and labeled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Acusnare Polypectomy (Duck Bill Shaped) Snare Used with an electrosurgical
The Issue: Complaints of the snare loop not completely retracting
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: iTotal Posterior Stabilized (PS) Knee Replacement System
The Issue: The labeling of the boxes and sterile pouches
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Elekta Unity
The Issue: In rare circumstances, due to reasons such as
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: icumedical ChemoLock Vial Spike
The Issue: There is a potential for one lot of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ARCHITECT MAGNESIUM
The Issue: Abbott internal testing has identified that the Magnesium
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BD FACSLyric 3L 10C with FACSuite Clinical Software v1.1.1
The Issue: A customer site was identified to have three
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica M220 F12 surgical microscope The Leica M220 F12 surgical
The Issue: The M220 optics may unintentionally drop into the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: cone-beam CT system
The Issue: ORTHOPANTOMOGRAPH OP 3D device has a defect in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 16600 / Fetzer Surgical Luikart Simpson OB Forceps14" (35.5cm)
The Issue: The firm had a report of doctors being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology: (a) Model
The Issue: Increased temperature in the probe-head surface with LOGIQ
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 12002 / Boss Instruments Simpson OB Forceps
The Issue: The firm had a report of doctors being
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.