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.
FDA Recall Z-2452-2025 · Posted 2025-08-27
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Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeLRO
Date Initiated2025-07-08
Product Quantity1145
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.
Firm Action
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.
Root Cause
Unknown/Undetermined by firm
Distribution Pattern
US Nationwide distribution tin the states of CA, FL, IA, and TX.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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