Reported Sep 3, 2025 · Ongoing
The Medline General Surgery Tray is customized to meet requirements of the hospitals and health care professionals…
MEDLINE INDUSTRIES, LP - Northfield
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: MEDLINE INDUSTRIES, LP - Northfield · 3 Lakes Dr · Northfield, IL · 60093-2753
Is this the product you have?
- 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.
- Lot codes and dates
7 of 7 products
Products covered by this recall Model / number Barcodes Product as published CDS983907M1019532758449840195327584499UDI 10195327584498 (ea) 40195327584499 (case) Kit lots: 24CBV474 24EBS619 24FBS722 24IBG491 24JBV978 25ABK333 25ABP110 CDS983907N1019845923916840198459239169UDI 10198459239168 (ea) 40198459239169 (case) Kit lots: 25CBI861 25EBH846 DYNJ69405B1019845928165540198459281656UDI 10198459281655 (ea) 40198459281656 (case) Kit lots: 25DMG402 25FMB391 DYNJ897051019845928213340198459282134UDI 10198459282133 (ea) 40198459282134 (case) Kit lot: 25CMH791 DYNJ9105471019845903121240198459031213UDI 10198459031212 (ea) 40198459031213 (case) Kit lots: 24HMK260 24IMH458 24JMB661 24JMC663 24JMH740 24JMJ718 24KMH904 25AMF426 25BMC308 25CMC866 25CMD885 25CMJ685 25DMC390 DYNJ9110081019845923362340198459233624UDI 10198459233623 (ea) 40198459233624 (case) Kit lots: 25DBT802 DYNJ9682800V1019532725724840195327257249UDI 10195327257248 (ea) 40195327257249 (case) Kit lots: 24EDA813 24FDA466 24GDA325 24IDB396 24JDB676 - Amount recalled
- 1145
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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