CLASS II ONGOING Device recall · Reported 3 Sep 2025 · FDA Enforcement Report
The Medline General Surgery Tray is customized to meet recalled
Medline Industries LP - Northfield is recalling The Medline General Surgery Tray is customized to meet requirements of the hospitals and, distributed nationwide in the US. The recall was initiated on 8 Jul 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2452-2025
- FDA event ID
- 97371
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Jul 2025
- FDA classified
- 27 Aug 2025
- Reported
- 3 Sep 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 8 Jul 2025 | Recall initiated by company | |
| 27 Aug 2025 | Classified by FDA | +50 days |
| 3 Sep 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution tin the states of CA, FL, IA, and TX.
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
US Nationwide distribution tin the states of CA, FL, IA, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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