Recall Z-2452-2025 ยท LRO General Surgery Tray
MEDLINE INDUSTRIES, LP - Northfield
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 c
| Date | Aug 27, 2025 (initiated Jul 8, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Unknown/Undetermined by 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. |
| Quantity | 1145 |
| Distribution | US Nationwide distribution tin the states of CA, FL, IA, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K213481 | Medline General Surgery Tray Medline Industries, Inc., May 24, 2022 |