CLASS II Device recall · Reported 2 Mar 2022 · FDA Enforcement Report

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect recalled

Stryker Sustainability Solutions is recalling REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect, distributed in Kansas, Texas. The recall was initiated on 21 Jan 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # 12983349
Quantity recalled40 units

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-0664-2022
FDA event ID
89535
Recalling firm
Stryker Sustainability Solutions, Tempe, AZ
Classification
Class II
Status
Terminated
Recall initiated
21 Jan 2022
FDA classified
22 Feb 2022
Reported
2 Mar 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Labeling Errors

Timeline

21 Jan 2022Recall initiated by company
22 Feb 2022Classified by FDA+32 days
2 Mar 2022Published in enforcement report+8 days

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

Reason for recall

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Product as listed by the FDA

REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder

Where it was distributed

US: KS OK TX OUS: None

KansasTexas

Questions about this recall

Is REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect recalled?

Yes. Stryker Sustainability Solutions recalled REF: 5921-018-135, Stryker Color Cuff, 18" (Red), Quick Connect on 21 Jan 2022. The recall is Class II and its status is Terminated. Recall number Z-0664-2022.

Why was it recalled?

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Which lots are affected?

Lot # 12983349

Where was it sold?

US: KS OK TX OUS: None

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 21 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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