The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals utili
FDA device recall Z-2452-2025 · posted 2025-08-27 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 1145
- Distribution
- US Nationwide distribution tin the states of CA, FL, IA, and TX.
- Date initiated
- 2025-07-08
- Date posted
- 2025-08-27
- Location
- Northfield, IL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Medline General Surgery Tray (K213481) | Medline Industries, Inc. | 2022-05-24 |