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 35021–35040 of 38,428 recalls
Recalled Item: TWINFIX" Ultra 4.5 mm PLLA-HA Suture Anchor with two #2 ULTRABRAID Sutures (blue
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OSTEORAPTOR 2.3 mm Suture Anchor with ULTRABRAID COBRAID Suture
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TWINFIX Ultra HA 4.5 mm Suture Anchor with 2 ULTRABRAID Suture
The Issue: Pinholes detected in a small number of primary
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aplio MX Diagnostic Ultrasound System SSA-780A Used for routine diagnostic
The Issue: The firm initiated this recall of certain Toshiba
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Aplio XG Diagnostic Ultrasound System SSA-790A Used for routine diagnostic
The Issue: The firm initiated this recall of certain Toshiba
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xario XG Diagnostic Ultrasound System SSA-680A Used for routine diagnostic
The Issue: The firm initiated this recall of certain Toshiba
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Xario Diagnostic Ultrasound System SSA-660A Used for routine diagnostic imaging
The Issue: The firm initiated this recall of certain Toshiba
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M Scotchcast
The Issue: 3M is conducting a voluntary product recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Outlook Safety Infusion System Burette Set. For intravenous fluid...
The Issue: Reports were received of an incorrectly assembled Outlook
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4)
The Issue: 3M ESPE is recalling Unitek Primary Stainless Steel
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Product Name: nanoPOINT Injector System
The Issue: The firm initiated this recall of one lot
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Juno DRF System. Mobile X-ray system These are general
The Issue: It has been discovered that the Air Kerma
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Getinge Assure Accufast Biological Indicators
The Issue: AccuFast Biological Indicator Lot SR-430 may have been
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Soft Tissue Retractor Small Extendible. Offset blade facilitates easy
The Issue: The small extendible Soft Tissue Retractor was recalled
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: NAVIS-EX
The Issue: Under certain circumstances, the Left eye image may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 00 4309-049-00 Trabecular Metal Reverse Shoulder Glenosphere Distractor Rx
The Issue: Zimmer is initiating a lot specific recall of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Leica BIOSYSTEMS
The Issue: The affected lots of the product may contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Large Buttress Compression Nut For Blade Guide Sleeve TFN The
The Issue: The Large Buttress Compression Nut For Blade Guide
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Synthes Tensioning Device The Synthes Osteogenesis System
The Issue: All lots of the Synthes Tensioning Device were
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Slipped Capital Femoral Epiphysis System Product Usage: Intended for fracture
The Issue: There is a possibility for the Guide Wires
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.