High FDA (Devices)·Z-2452-2025·Announced 2025-09-03

Surgery trays recalled because they contain recalled tourniquet cuffs

Medline General Surgery Trays are recalled because they contain recalled Stryker Color Cuff tourniquet cuffs whose flange may detach, compromising air pressure and risking tourniquet failure. 1,145 units are affected.

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: Rubric level 3 covers risk-of-harm products where injury has not yet been reported; the notice describes potential tourniquet failure and hemorrhaging risk, with no injuries reported.

Plain-English summary

Medline General Surgery Trays, customised sterile single-use kits whose components depend on the specific procedure, are being recalled. Affected SKUs include CDS983907M, CDS983907N, DYNJ69405B and DYNJ89705, with kit lot numbers listed in the recall notice. The recall covers 1,145 units distributed in California, Florida, Iowa and Texas.

The affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated its recall because of a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. That detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and an increased risk of patient hemorrhaging. The FDA classified the action as Class II.

Hospitals holding affected kit lots should quarantine them and follow Medline's instructions for return or replacement.

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 — Procedure Kits
Hazard: component-recall
tourniquet-failure
hemorrhage-risk
class-ii
Affected units: 1,145

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.

The notice also names 4 states specifically:

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

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