The Recall Desk
HighFDA (Devices)·Z-0451-2026·Announced 2025-11-19

[pending] Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S S

Pending LLM rewrite. Source: FDA_DEVICE Z-0451-2026.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Pending LLM scoring against the rubric.

Plain-English summary

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.

The recalled product

Product
Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY
Manufacturer
Medline Industries, LP
Category
Medical Device — Devices

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (8)

  • DR SALMA'S SPINE DYNJ909111F UDI-DI 40198459130794 (case)
  • 10198459130793 (ea) Lots 25FBE036 25GBV759
  • ORTHO SPINE FUMICH DYNJ901047R UDI-DI 40198459130466 (case)
  • 10198459130465 (ea) Lots 25FBR230 25GBU693
  • PATTERSON TOTAL JOINT DYNJ909117G UDI-DI 40198459130480 (case)
  • 10198459130489 (ea) Lots 25FBO307 25GBN625
  • TOTAL JOINT DYNJ902308K UDI-DI 40198459130596 (case)
  • 10198459130458 (ea) Lot 25IBM788

Distribution

Distributed nationwide across the United States.

Related recalls

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