Recall Z-0451-2026— Medline Industries, LP
Class I · Ongoing
Class I FDA medical device recall by Medline Industries, LP, initiated 2025-10-10. FDA's recall record names no specific 510(k) clearance for this event. Product: Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY. Reason: Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment..
- Recalling firm
- Medline Industries, LP
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2025-10-10
- Firm location
- Northfield, IL, United States
Product description
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Reason for recall
Firm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to hypoxia, hypoventilation, and inadequate delivery of inhaled anesthetic agents, which may result in serious injury or death. Volatile anesthetics may also escape into the operating room environment.
Data sourced from openFDA. This site is unofficial and independent of the FDA.