The Recall Desk
HighFDA (Devices)·Z-2452-2025·Announced 2025-09-03

Medline General Surgery Tray kits recalled for tourniquet cuff weld defect

Medline is recalling surgical tray kits containing Stryker tourniquet cuffs that may fail due to a manufacturing defect at the weld, risking patient hemorrhaging.

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: This is a risk-of-harm medical device with a real manufacturing defect and serious potential consequence (patient hemorrhaging), but the source contains no reports of actual injuries or illnesses. Per the FDA rubric, risk-of-harm products where injury has not yet been reported score 3.

Plain-English summary

Medline Industries is recalling 1,145 General Surgery Tray kits distributed nationwide that contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. These kits are customized surgical trays assembled with various medical device and drug components according to hospital specifications.

The recall was initiated due to a manufacturing defect in which the flange may detach from the bladder at the welded connection point in the tourniquet cuff. This detachment compromises the cuff's ability to maintain adequate air pressure during surgery.

If the tourniquet fails to maintain pressure, patients may experience hemorrhaging, a serious surgical complication. The affected kits were distributed to hospitals and healthcare facilities in California, Florida, Iowa, and Texas, among other locations nationwide.

Healthcare facilities that received affected kits should stop using them and contact Medline Industries for instructions. Facilities should verify their surgical tray lot numbers against the recall list to ensure the affected tourniquet cuffs are not used in patient care.

The recalled product

Product
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utilizing them. The kit is provided sterile, single-use and includes a range of components dependent upon the specific procedure. These kits will be assembled using
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Equipment / Tourniquets
Hazard
  • tourniquet-failure
  • hemorrhage-risk
  • weld-defect

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 (1)

  • 4. SKU DYNJ89705 UDI 10198459282133 (ea) 40198459282134 (case) Kit lot: 25CMH791

Distribution

Distributed nationwide across the United States.

Related recalls

Same category