The Medline General Surgery Tray is customized to meet requirements… — Class II medical device recall Z-2452-2025
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2025-09-03, distributed nationwide. Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments ini
| Recall number | Z-2452-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2025-07-08 |
| Classified | 2025-08-27 |
| Reported by FDA | 2025-09-03 |
| Distributed | Nationwide (US) |
| Quantity | 1,145 |
| Reason classes | sterility, device malfunction |
| UPC / GTIN / UDI-DI | 10195327257248, 10195327584498, 10198459031212, 10198459233623, 10198459239168, 10198459281655, 10198459282133, 40195327257249, 40195327584499, 40198459031213, 40198459233624, 40198459239169, 40198459281656, 40198459282134 |
| Lot numbers | 24CBV474, 24EBS619, 24EDA813, 24FBS722, 24FDA466, 24GDA325, 24HMK260, 24IBG491, 24IDB396, 24IMH458, 24JBV978, 24JDB676, 24JMB661, 24JMC663, 24JMH740, 24JMJ718, 24KMH904, 25ABK333, 25ABP110, 25AMF426, 25BMC308, 25CBI861, 25CMC866, 25CMD885, 25CMH791, 25CMJ685, 25DBT802, 25DMC390, 25DMG402, 25EBH846, 25FMB391 |
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 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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2452-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.