Class II U.S. Food and Drug Administration

The Medline General Surgery Tray is customized to meet requirements recall: Affected kits contain recalled Stryker Color Cuff Sterile Disposable

Recall published 1+ years ago

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.

The hazard: Sterility or particulate concern

Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

What the notice says: 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.

Why it matters: The product was made or packaged in conditions that cannot assure sterility, or visible particles were found in it. For anything injected, infused or used in the eye, that is a direct route for contamination into the body.

Symptoms and when to call a doctor

Watch for fever, chills, pain, redness, swelling or discharge at an injection site, and for a red, painful or suddenly blurred eye after using an eye product. Any of these needs same-day medical attention. Do not wait to see whether it settles, and tell the clinician which product and lot you used so it can be reported against the recall.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-2452-2025
Published
September 3, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
MEDLINE INDUSTRIES, LP - Northfield
Product type
Medical devices
Units affected
1145
Distribution
Nationwide
Made in
United States
Lot / code info
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
UPC codes
10195327584498, 40195327584499, 10198459239168, 40198459239169, 10198459281655, 40198459281656, 10198459282133, 40198459282134, 10198459031212, 40198459031213, 10198459233623, 40198459233624, 10195327257248, 40195327257249

Products covered by this recall

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.

Check your product

The notice names 23 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 10195327584498
  • 40195327584499
  • 10198459239168
  • 40198459239169
  • 10198459281655
  • 40198459281656
  • 10198459282133
  • 40198459282134
  • 10198459031212
  • 40198459031213
  • 10198459233623
  • 40198459233624
  • 10195327257248
  • 40195327257249

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25DMG402 25FMB391
  • 25CMH791
  • 25DBT802

Model or item number

On the rating label, the box or the instruction sheet.

  • CDS983907N UDI 10198459239168
  • DYNJ69405B UDI 10198459281655
  • DYNJ89705 UDI 10198459282133
  • DYNJ910547 UDI 10198459031212
  • DYNJ911008 UDI 10198459233623
  • DYNJ9682800V UDI 10195327257248

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Sterility

MEDLINE INDUSTRIES, LP - Northfield — Particulate matter or a sterility failure prompted this notice, the most common reason injectable and ophthalmic products are withdrawn.

  1. Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.
  2. Call your prescriber or pharmacy today about a replacement from an unaffected lot — do not simply skip doses of a medicine you depend on.
  3. If you are a clinic or pharmacy, quarantine the stock and work it through your usual recall log.
  4. Report any infection or reaction you think the product caused to FDA MedWatch.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: MEDLINE INDUSTRIES, LP - Northfield — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was MEDLINE INDUSTRIES, LP - Northfield medical devices 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. Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker Instruments initiated this recall due to a potential manufacturing defect in which…

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 10195327584498, 40195327584499, 10198459239168; lot code 25DMG402 25FMB391, 25CMH791, 25DBT802; model number CDS983907N UDI 10198459239168, DYNJ69405B UDI 10198459281655, DYNJ89705 UDI 10198459282133. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the affected lot and check the lot number on your own carton or vial against the codes listed above.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

Related recalls