FDA Medical Device Recalls (openFDA)
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 contents, quantity, and placement of individual items in the kit.
- Recall number
- Z-2452-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- 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.
- Status
- Open, Classified
- Initiated
- 2025-07-08
- Posted
- 2025-08-27
- Terminated
- not on file
- 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.
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K213481"]
- PMA numbers
- not on file
- Product code
- LRO
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28