Use caution Medical device recall · FDA · Published July 8, 2025

Medline Surgery Tray Recall: Tourniquet Cuff Detachment Risk

Medline recalls specific surgery trays due to potential tourniquet cuff detachment causing bleeding risks. Affected kits include SKUs CDS983907M, CDS983907N, DYNJ69405B, etc. with specific lot numbers.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2452-2025Medical device Medline ›

Use caution until it’s fixed

Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

Take action

Contact the company

Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753

✎ GovInfoNow plain-language explainer

Medline is recalling certain surgery trays that include Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. These cuffs may detach at the weld point, leading to tourniquet failure and increased bleeding risk during medical procedures. Read more at govinfonow.com/recall/51830-medline-surgery-tray-recall-tourniquet-cuff-detachment-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/51830-medline-surgery-tray-recall-tourniquet-cuff-detachment-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2452-2025

Cite this page

“Medline Surgery Tray Recall: Tourniquet Cuff Detachment Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/51830-medline-surgery-tray-recall-tourniquet-cuff-detachment-risk. Based on FDA recall #Z-2452-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2452-2025%22&limit=1).

The FDA announced on July 8, 2025, that Medline Industries LP is recalling The Medline General Surgery Tray due to a potential manufacturing defect in included Stryker tourniquet cuffs. Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs whose flanges may detach from the bladder. Owners should stop using the affected trays immediately.

How to tell if you have it

Brand: Medline
Product: The Medline General Surgery Tray
SKU CDS983907M UDI 10195327584498 (ea) 40195327584499 (case) Kit lots: 24CBV474 24EBS619 24FBS722 24IBG491 24JBV978 25ABK333 25ABP110
SKU CDS983907N UDI 10198459239168 (ea) 40198459239169 (case) Kit lots: 25CBI861 25EBH846
SKU DYNJ69405B UDI 10198459281655 (ea) 40198459281656 (case) Kit lots: 25DMG402 25FMB391
SKU DYNJ89705 UDI 10198459282133 (ea) 40198459282134 (case) Kit lot: 25CMH791
SKU DYNJ910547 UDI 10198459031212 (ea) 40198459031213 (case) Kit lots: 24HMK260 24IMH458 24JMB661 24JMC663 24JMH740 24JMJ718 24KMH904 25AMF426 25BMC308 25CMC866 25CMD885 25CMJ685 25DMC390
SKU DYNJ911008 UDI 10198459233623 (ea) 40198459233624 (case) Kit lots: 25DBT802
SKU DYNJ9682800V UDI 10195327257248 (ea) 40195327257249 (case) Kit lots: 24EDA813 24FDA466 24GDA325 24IDB396 24JDB676
Distribution: US Nationwide distribution in the states of CA, FL, IA, and TX

The hazard

The Stryker Color Cuff Sterile Disposable Tourniquet Cuffs included in the kits have a potential manufacturing defect where the flange may detach from the bladder at the welded connection point. This detachment compromises the cuff's ability to maintain adequate air pressure, potentially resulting in tourniquet failure and increased risk of patient hemorrhaging.

Context

GovInfoNow's records show Medline Industries LP - Northfield has 119 other recalls on record since 2021-10-22. Other recent recalls include Medline medical kits with light failure in newborn resuscitation kits (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and ReNewal Reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Other recent recalls of similar products include Stryker Color Cuff 18"/24" Quick Connect Dual Port Cuffs Recall: Risk of Detachment (2026-03-12), Merit Medical Vascular Tray Recall: Handle May Detach During Procedure (2025-12-04), and Bard Peripheral Vascular Recall: Broviac Cutdown Trays with SureCuff Cuff Risk of Sterile Barrier Compromise (2025-12-12).

How to tell if you have this one

Check for the specific SKUs: CDS983907M, CDS983907N, DYNJ69405B, DYNJ89705, DYNJ910547, DYNJ911008, or DYNJ9682800V. Also look for the listed kit lot numbers such as 24CBV474, 24EBS619, etc.

Brand
Medline
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Stop Using Affected Kits
Immediately discontinue use of the recalled surgery trays that include the specific SKUs and lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 4 states.

FDA distribution: “US Nationwide distribution tin the states of CA, FL, IA, and TX.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Florida, Iowa, Texas.

Recall timeline

FDA published this recall 57 days after the firm started it.

Jul 8, 2025Firm started the recall
Aug 27, 2025FDA classified it Class II
Sep 3, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/51830-medline-surgery-tray-recall-tourniquet-cuff-detachment-risk">Medline Surgery Tray Recall: Tourniquet Cuff Detachment Risk (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-2452-2025 (July 8, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2452-2025 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.