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 24781–24800 of 38,428 recalls
Recalled Item: Covidien Curity Wet Dressing 8 x 4 (20.3 cm x 10.2 cm)
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm)
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Curity Eye Pad Item Code: 91650 The sterile eye
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The CG+ Arrow PIC Catheters permit venous access to the
The Issue: Arrow International, Inc. notified its customers who received
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Curity Eye Pad Item Code: 03201 The sterile eye
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Curity Eye Pad Oval
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Kerlix Super Sponge Saline Dressing
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Covidien Curity Sodium Chloride Dressing
The Issue: Product sterility is compromised due to breach of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500
The Issue: Siemens Healthcare Diagnostics has confirmed that in isolated
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Panta Nail
The Issue: Voluntary recall/Removal of Panta and Panta XI Nails
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk"
The Issue: for product labeled as Actinomyces odontolyticus is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each...
The Issue: for product labeled as Actinomyces odontolyticus is
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vertebral Motion Analyzer (VMA)
The Issue: Ortho Kinematics notified customers that errors were contained
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Myelotec Video Guided Catheters
The Issue: Obstructed/blocked port from defective VGC Access Port Body
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: eCare Coordinator Product Usage: is software intended for use in
The Issue: eCareCoordinator (eCC) is intended for use in data
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas 8100 bi-directional (BRF) module with Software Version 02-xx
The Issue: "Roche Diagnostics Corp. initiated a voluntary correction because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Cobas 8100 uni-directional (BRF) module with Software Version 02-xx
The Issue: Roche Diagnostics Corp. initiated a voluntary correction because
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Inion GRT Tack
The Issue: Aluminum pouch seal was noticed to be defective
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Por fullct fem st 17x200mm
The Issue: Zimmer Biomet Inc. initiated a field action on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Segmental fluted stem
The Issue: Zimmer Biomet Inc. initiated a field action on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.