Medline Industries, LP — Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- October 10, 2025
International distribution to Mexico and Panama. US nationwide distribution to the following: AK AL AR AZ CA CO CT FL GA IA IL IN KS KY MA ME MI MN MO MS MT NC NJ NY OH OR PA PR RI SC TN TX WA WI;
What's affected?
- Product
- Convenience kits; DYNJ901046M GYN ROBOTIC DYNJ909120D ROBOTIC PROSTATE
- Lot code
- 25FBM810
Additional details
GYN ROBOTIC DYNJ901046M UDI-DI 40198459130381 (case), 10198459130380 (ea) Lots 25FBM810 25GBK307; ROBOTIC PROSTATE DYNJ909120D UDI-DI 40198459130541 (case), 10198459130540 (ea) Lots 25GBT821 25IBF809
What should I do?
Recommended action
Class I recall. Voluntary: Firm initiated Quantity affected: 96,406 total units.
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