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 30181–30200 of 38,428 recalls
Recalled Item: Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail...
The Issue: The entire scope of 4.5mm Cortical Screws listed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Lerner Laboratories Mucolexx
The Issue: Richard Allan Scientific (RAS) is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Mucolytic Agent 1 pint/473 ml
The Issue: Richard Allan Scientific (RAS) is initiating a recall
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product
The Issue: Failures of the splice repair kit if exposed
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product
The Issue: Acclarent determined that one single RELIEVA FLEX Sinus
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Alcon Custom Pak. The Alcon Customer Pak is an
The Issue: The supplier of the Devon Light Glove, a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VenaSeal
The Issue: sterility breach of the outer packaging (pouch)
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Custom Surgical Kits containing Medtronic Covidien Devon(TM) Light Gloves: ANGIO
The Issue: Surgical kits contain Medtronic Covidien Devon(TM) Light Gloves
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval
The Issue: One lot of the Extractor" Pro RX Retrieval
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile
The Issue: Recovery of high count of gram positive rods
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CRIT-LINE Blood Chamber- an accessory to the Crit line III-
The Issue: Blood chamber connection leaks during the use of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 0.9% Sodium Chloride Injection
The Issue: Incorrect expiration date on label
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: D-fend
The Issue: A potential safety issue due to loss of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EliteCore Full Core Biopsy Device. EliteCore 18G
The Issue: for the device cannula to overthrow past
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision SI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision SI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome SI Chronic Catheter Kit 14.5 Fr x 28cm Item Code: 8888245064
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Catheter Sport Pack w/VenaTrac Stylet 14.5
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Palindrome Precision HSI Chronic Catheter Kit w/VenaTrac Stylet 14.5 Fr
The Issue: Catheters may not meet antimicrobial specification
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.