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 10381–10400 of 38,428 recalls
Recalled Item: Palindrome Precision SI Chronic Catheter
The Issue: There is a potential leaking condition within the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: TruClear Hysteroscopic Tissue Removal System Control Unit- designed to meet
The Issue: Electrical component failure within the control unit. The
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve
The Issue: The product is not able to provide irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HydroSurg Plus Laparoscopic Irrigator with Nezhat-Dorsey SmokEvac Trumpet Valve
The Issue: The product is not able to provide irrigation
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as follows: a. BEDSIDE PICC CDS
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline convenience kits: a. VENOUS ACCESS PACK-LF
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: a. WET SKIN PREP TRAY
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Custom procedural kits labeled as follows: a. GP-NEURO PACK
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Recalled by MEDLINE INDUSTRIES, LP - SPT Due to Kits contain leaking bottles...
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Convenience kits labeled as: a. MAJOR VASCULAR CDS
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline Product Name: convenience kits labeled as: LAP
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline convenience kits labeled as: a. MIDDLE EAR PACK-LF
The Issue: Kits contain leaking bottles of isopropyl alcohol
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: SteriSpine PS kit of 2 Multi-Axial Fenestrated Screws
The Issue: The type of screw printed on the traceability
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Ambu VivaSight 2 DLT
The Issue: Firm has received complaints on the device concerning
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile convenience kits: (1) regard Item #830099008
The Issue: Some nonsterile components that were supposed to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Hobbs Medical Polypectomy Snare
The Issue: During use, the sheath of the device may
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Nonsterile convenience kit: regard Item #830014016
The Issue: Some nonsterile components that were supposed to be
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Trevo Trak 21 Microcatheter
The Issue: Microcatheter product label on the carton is missing
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Service manuals for the CT
The Issue: As a result of unclear guidance in the
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: YelloPort Elite Universal Seal. For use in laparoscopic procedures.
The Issue: There is the potential that YelloPort Elite Universal
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.