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The Medline General Surgery Tray is customized to meet… recallZ-2452-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Jul 8, 2025

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Unknown/Undetermined by firm

What the company is doing

On July 8, 2025, the firm communicated the recall to customers who had received affected kits. Medline instructed customers to request stickers to over-label the affected convenience kits with a warning label, indicating to remove the affected component and replace it with product from supply. No kits are to be returned.

Recall details

Recall number
Z-2452-2025
Status
Open, Classified
Initiated by the company
Jul 8, 2025
Posted by the FDA
Aug 27, 2025
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1145
Product code
LRO
FDA submissions
K213481
Distribution
US Nationwide distribution tin the states of CA, FL, IA, and TX.

Product description

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 Medline and other manufacturers medical device components and drug components in some cases. Customers specify the kit contents, quantity, and placement of individual items in the kit.

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

1. SKU CDS983907M UDI 10195327584498 (ea) 40195327584499 (case) Kit lots: 24CBV474 24EBS619 24FBS722 24IBG491 24JBV978 25ABK333 25ABP110; 2. SKU CDS983907N UDI 10198459239168 (ea) 40198459239169 (case) Kit lots: 25CBI861 25EBH846 3. SKU DYNJ69405B UDI 10198459281655 (ea) 40198459281656 (case) Kit lots: 25DMG402 25FMB391; 4. SKU DYNJ89705 UDI 10198459282133 (ea) 40198459282134 (case) Kit lot: 25CMH791; 5. SKU DYNJ910547 UDI 10198459031212 (ea) 40198459031213 (case) Kit lots: 24HMK260 24IMH458 24JMB661 24JMC663 24JMH740 24JMJ718 24KMH904 25AMF426 25BMC308 25CMC866 25CMD885 25CMJ685 25DMC390; 6. SKU DYNJ911008 UDI 10198459233623 (ea) 40198459233624 (case) Kit lots: 25DBT802; 7. SKU DYNJ9682800V UDI 10195327257248 (ea) 40195327257249 (case) Kit lots: 24EDA813 24FDA466 24GDA325 24IDB396 24JDB676

Devices named in this recall

7 devices in the FDA device registry whose identifier appears in the recall's code information.

Other devices under the same FDA submission

321 devices cleared under K213481 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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