Class I U.S. Food and Drug Administration

Medline Industries, LP Convenience kits recall: Firm received multiple complaints of anesthesia circuit leaks due to cracks

Recall published 11 months ago

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 hazard: Device safety concern

A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

What the notice says: 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.

Why it matters: The FDA recorded an enforcement action against this device. Most device recalls are corrections rather than removals, so the device often stays in use while the manufacturer issues a fix.

Recall details

Recall number
Z-0451-2026
Published
November 19, 2025
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
96,406 total units
Distribution
Nationwide
Made in
United States
Lot / code info
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), 10198459130595 (ea) Lots 25FBB321 25GBU688 KYPHOPLASTY DYNJ909113F UDI-DI 40198459130459 (case), 10198459130458 (ea) Lot 25IBM788
UPC codes
40198459130794, 10198459130793, 40198459130466, 10198459130465, 40198459130480, 10198459130489, 40198459130596, 10198459130595, 40198459130459, 10198459130458

Products covered by this recall

Convenience kits; DYNJ901047R ORTHO SPINE FUMICH DYNJ902308K TOTAL JOINT DYNJ909111F DR SALMA'S SPINE DYNJ909117G PATTERSON TOTAL JOINT DYNJ909113F KYPHOPLASTY

Check your product

The notice names 15 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 40198459130794
  • 10198459130793
  • 40198459130466
  • 10198459130465
  • 40198459130480
  • 10198459130489
  • 40198459130596
  • 10198459130595
  • 40198459130459
  • 10198459130458

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25FBE036 25GBV759
  • 25FBR230 25GBU693
  • 25FBO307 25GBN625
  • 25IBM788 — 96
  • 406 total units

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Device

Medline Industries, LP — A device recall was filed for this product. For anything implanted or relied on daily, the clinician comes before the paperwork.

  1. Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.
  2. Ask the supplier or clinic that provided it what the remedy is in your case.
  3. If you are a facility, quarantine affected stock and log the correction.
  4. Report device problems to the FDA through MedWatch.

Claiming on a recalled device

Device recalls are tracked by serial and lot number, so your claim moves faster if you lead with those.

  • Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.
  • Ask explicitly whether your unit is in the affected range; many recalls cover only part of a model line.
  • If you need the device daily, ask what interim arrangement they offer while the remedy is carried out.
  • Log the date, the name and the reference number of every call. Device recalls can run for months.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Medline Industries, LP medical devices recalled?

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. 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…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 40198459130794, 10198459130793, 40198459130466; lot code 25FBE036 25GBV759, 25FBR230 25GBU693, 25FBO307 25GBN625. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Match the model, catalogue, lot and serial numbers on your device against the identifiers on this page.

Can I get my money back?

Have the model, catalogue, lot and serial numbers ready before you call — they are on the device label or its box.

Where was the recalled product sold?

It was distributed nationwide.

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