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 3681–3700 of 38,428 recalls
Recalled Item: Medtronic DLP Aortic Root Cannula with Flow-Guard
The Issue: There is the potential for a potential sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TEMA Elbow - Axle Small .15.010 TEMA Elbow -
The Issue: Due to a potential difference in mechanical behavior
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients
The Issue: Due to issues with battery depletion and inability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Baxter Spectrum IQ Infusion System with Dose IQ Safety Software
The Issue: The door on the Spectrum IQ Infusion pump
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT
The Issue: Complaint received indicating that a package contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT
The Issue: Complaint received indicating that a package contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew GENESIS II NONPOROUS POSTERIOR STABILIZED FEMORAL COMPONENT
The Issue: Complaint received indicating that a package contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT
The Issue: Complaint received indicating that a package contained a
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE
The Issue: Due to defects on primary packaging pouch that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hollister CalciCare Calcium Alginate Dressing calcium alginate dressings
The Issue: Due to defects on primary packaging pouch that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for
The Issue: Due to defects on primary packaging pouch that
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin@home Transmitter The Merlin@home" (M@h) transmitter is intended
The Issue: Due to heart transmitter not being able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Merlin@home with the MerlinOnDemand capability Transmitter Merlin@home with
The Issue: Due to heart transmitter not being able to
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number:
The Issue: For the Z-800WF pumps, the WiFi software was
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Precice Max .0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight
The Issue: Due to potential issues with design, manufacturing and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bard Marquee Disposable Core Biopsy Instrument Kit: BARD MARQUEE KIT
The Issue: Disposable biopsy instruments were potentially manufactured missing the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: IMMULITE 2000 PSA assay
The Issue: The IMMULITE 2000 PSA assay for use on
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: The Access Cortisol assay is a paramagnetic particle
The Issue: The Access Cortisol assay protocol file (APF) applies
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: AVOXimeter 1000E
The Issue: Values used to calibrate whole blood oximeter instruments
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: 1) Flex Extenders
The Issue: Due to connector within the circuit flex extender
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.