Use caution Medical device recall · FDA · Published March 1, 2023

Stryker Color Cuff Tourniquet Cuff Recall: Pressure Issues Risk Blood Loss

Stryker recalls disposable tourniquet cuffs that may not hold pressure properly, risking blood loss during surgery. Affected units include specific catalog numbers and lot dates. Contact Stryker for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1339-2023Medical device Stryker ›

Use caution until it’s fixed

Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood loss, hemorrhage or, in exceedingly rare situations, other major complications

Take action

Contact the company

Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711

✎ GovInfoNow plain-language explainer

Stryker is recalling disposable tourniquet cuffs that may not hold pressure correctly during surgery, potentially causing blood loss or complications. This affects specific model numbers and production lots sold in recent months. Read more at govinfonow.com/recall/58800-stryker-color-cuff-tourniquet-cuff-recall-pressure-issues-risk-blood.

Source Summary by GovInfoNow · govinfonow.com/recall/58800-stryker-color-cuff-tourniquet-cuff-recall-pressure-issues-risk-blood · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1339-2023

Cite this page

“Stryker Color Cuff Tourniquet Cuff Recall: Pressure Issues Risk Blood Loss.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/58800-stryker-color-cuff-tourniquet-cuff-recall-pressure-issues-risk-blood. Based on FDA recall #Z-1339-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1339-2023%22&limit=1).

The FDA announced on March 1, 2023, that Stryker Corporation voluntarily recalled Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuffs due to pressure failure risks. The hazard may lead to operative site blood loss or hemorrhage.

How to tell if you have it

Brand: Stryker
Product: Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK
Catalog number: 5921-030-135NS
UPC: 07613327606157
Lot numbers: 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, 2022122602
Distribution: US Nationwide
Units affected: 1225

The hazard

According to the FDA, the cuffs may not achieve desired pressure or hold pressure during initial set-up. This failure can result in operative site blood loss, hemorrhage, or other major complications.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include the AHTO Tube Set leaking during use (June 8, 2026) and the Neptune Smart Docking Station electrical shock risk (May 6, 2026). Other recent recalls of similar products include the Stryker Color Cuff 18"/24" Quick Connect Dual Port Cuffs detachment risk (March 12, 2026), Hamilton Medical IntelliCuff leakage error risk (May 22, 2026), and Bard Peripheral Vascular Broviac Cutdown Trays sterile barrier compromise (December 12, 2025).

How to tell if you have this one

Check for the catalog number 5921-030-135NS on the product label. Affected units were sold with lot numbers 2022111803, 2022112901, 2022121911, 2022121912, 2022122601, or 2022122602.

Brand
Stryker
Product
Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS
Category
Medical device

FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
US Nationwide distribution.

Recall number	Product, codes & lots	Quantity
Z-1339-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities; GTIN: 07613327606157 Lot Numbers; 2022111803 2022112901 2022121911 2022121912 2022122601 2022122602	1225 units (packs of 10)
Z-1340-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,2PRT QUICK Catalog number: 5921-030-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities; GTIN: 07613327606195 Lot Numbers: 2022111804 2022112902 2022121909 2022121910 2022122603 2022122604	1206 units (packs of 10)
Z-1341-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,1PRT QUICK Catalog number: 5921-034-135NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities; GTIN: 07613327606171 Lot Numbers: 2022111805 2022112801 2022112803 2022112804 2022112805 2022112806 2022112807 2022112808 2022120506 2022120507 2022120508	1979 units (packs of 10)
Z-1342-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 34X4,1BLA,2PRT QUICK Catalog number: 5921-034-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities; GTIN: 07613327606188 Lot Numbers: 2022111806 2022112802 2022120501 2022120502 2022120503 2022120504 2022120505 2022120701	1617 units (packs of 10)
Z-1343-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1 BLA,1PRT QUICK Catalog number: 5921-218-135NS; GTIN: 07613327606133 Lot Numbers: 2022111801 2022112903 2022121201 2022121202 2022121203 2022121204 2022121205 2022121206	1730 units (packs of 10)
Z-1344-2023	Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 18X4,1BLA,2PRT QUICK Catalog number: 5921-218-235NS Indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patient s extremities; GTIN: 07613327606164 Lot Numbers: 2022111802 2022112904 2022121301 2022121302 2022121905 2022121906 2022121907 2022121908	1707 units (packs of 10)

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the catalog number 5921-030-135NS on the tourniquet cuff label.
Contact Stryker
Reach out to Stryker Corporation for further instructions on handling affected units.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 42 days after the firm started it.

Mar 1, 2023Firm started the recall
Apr 4, 2023FDA classified it Class II
Apr 12, 2023Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/58800-stryker-color-cuff-tourniquet-cuff-recall-pressure-issues-risk-blood">Stryker Color Cuff Tourniquet Cuff Recall: Pressure Issues Risk Blood Loss (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1339-2023 (March 1, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1339-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.