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 201–220 of 38,428 recalls
Recalled Item: VITEK 2 Gram-negative Susceptibility Cards Containing o Polymyxin B (pb02n)
The Issue: risk of Quality Control failures and/or false
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR 3D Knee Tibial Insert 5R 14MM
The Issue: 942-01-40G acetabular system package was found to contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: EMPOWR Acetabular System: Liner
The Issue: 942-01-40G acetabular system package was found to contain
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.
The Issue: Tyvek bag seal issue which may compromise sterility
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATEC Lateral Navigation Disc Prep Instruments LIF NAV
The Issue: Due a design issue where the navigated array
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: ATEC Lateral Navigation Disc Prep Instruments LIF NAV
The Issue: Due a design issue where the navigated array
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET
The Issue: Under circumstances involving exposure to particular chemicals and
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medica Capillary Tubes
The Issue: A systematic positive bias of up to 20%
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Prodisc Product Name: Prodisc C SK Model/Catalog Number:
The Issue: Mislabeling
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: BEAR Implant. Model Number: 1000.
The Issue: Incorrect expiration date on label that extends beyond
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: da Vinci 5 Surgeon Console Viewer Display
The Issue: Robotic-assisted surgical system has Viewer Display manufactured with
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R
The Issue: Ortho images acquired with preset automatic horizontal flip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft
The Issue: Incorrect expiration date
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T
The Issue: Ortho images acquired with preset automatic horizontal flip
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Chest Drainage Units and Accessories: Product Code Description 1. 8888571562
The Issue: The firm is updating the IFU to clarify
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Feminine hygiene products
The Issue: exposure of rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Toothbrushes
The Issue: exposure of rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Condoms
The Issue: exposure of rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: PREGNANCY TEST 24CT
The Issue: exposure of rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Bandages and first aid kits: FIRST AID KIT 24/42PC
The Issue: exposure of rodents and rodent activity in
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.