CLASS II Device recall · Reported 11 Dec 2019 · FDA Enforcement Report

Color Cuff Disposable Tourniquet Cuff X, 1BLA recalled

Stryker Instruments Div. of Stryker is recalling Color Cuff Disposable Tourniquet Cuff X, 1BLA (Single Bladder), 2PRT(Dual Port) Quick, distributed nationwide in the US. The recall was initiated on 6 Nov 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesGTIN: 37613154599296, Lot Numbers 60180374, 60181194

Quantity recalled16,380 total

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-0593-2020
FDA event ID: 84316
Recalling firm: Stryker Instruments Div. of Stryker, Portage, MI
Classification: Class II
Status: Terminated
Recall initiated: 6 Nov 2019
FDA classified: 2 Dec 2019
Reported: 11 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Surgical Instruments

Timeline

6 Nov 2019	Recall initiated by company
2 Dec 2019	Classified by FDA	+26 days
11 Dec 2019	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Color Cuff Disposable Tourniquet Cuff, 18 inch X 3 inch, 1BLA (Single Bladder), 2PRT(Dual Port) Quick Connect Connector, Product Number 5921-018-235 - Product Usage: The Stryker Disposable Tourniquet Cuff (cuff) is indicated for use in surgical procedures that require the temporary occlusion of blood flow in a patients extremities during surgical procedures to produce greater visualization of the operative field.

Where it was distributed

Worldwide distributions - US Nationwide distributions in the states of AL, CD, HI, IA, ID, IN, KS, KY, MA, ME, MI, MN, MT, NC, NE, NH, NJ, NV, NY, OK, OR, PA, SC, SD, TN, VA, WI, WV, and WY. Countries of Argentina, Australia, Canada, and Netherlands.

Nationwide Alabama Hawaii Iowa Idaho Indiana Kansas Kentucky Massachusetts Maine Michigan Minnesota Montana North Carolina Nebraska New Hampshire New Jersey Nevada New York Oklahoma Oregon

Questions about this recall

Why was it recalled?

There is a potential for the cuff to leak air leading to a loss of vascular occlusion.

Which lots are affected?

GTIN: 37613154599296, Lot Numbers 60180374, 60181194

Where was it sold?

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.

Other products in this recall event

1 other product · FDA event 84316

Reported	Class	Recall	Company	Reason	Where
11 Dec 2019	CLASS II	Color Cuff Disposable Tourniquet Cuff X, 1BLA recalled	Stryker Instruments Div. of Stryker	Packaging Defects	Nationwide

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