Stry: Color Cuff 18" Red - Mislabeling Risk
Stryker recalls 18" Red Color Cuff (Quick Connect Single Port) due to mislabeling as single-bladder when it's dual-bladder. This could lead to improper use in medical settings.
Lower-risk recall
Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.
Contact the company
What happened, in plain English
Stryker is recalling a specific type of medical cuff that's mislabeled as single-bladder when it's actually dual-bladder. This could cause improper use in medical settings if someone assumes it's single-bladder. Read more at govinfonow.com/recall/61232-stry-color-cuff-18-red-mislabeling-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/61232-stry-color-cuff-18-red-mislabeling-risk · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0664-2022
Cite this page
“Stry: Color Cuff 18" Red - Mislabeling Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61232-stry-color-cuff-18-red-mislabeling-risk. Based on FDA recall #Z-0664-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0664-2022%22&limit=1).
Why it’s dangerous
The cuff is labeled as single-bladder but is actually dual-bladder. This mislabeling could lead to improper use in medical settings where the cuff's design is critical for proper function.
Who’s affected
Healthcare professionals using this cuff for medical purposes may be affected. Patients receiving care with this cuff could be at risk if the mislabeling leads to incorrect application.
How to tell if you have this one
Check for the model: Stryker Color Cuff, 18" (Red), Quick Connect Single Port, Single Bladder. Lot number 12983349 is associated with this recall.
- Brand
Stryker- Category
Medical device
What to do — step by step
Check Product Label
Look for the model name and lot number on the cuff to confirm if it's part of the recall.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “US: KS OK TX OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Kansas, Oklahoma, Texas.
Recall timeline
FDA terminated this recall 3.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product dangerous?
The recall is due to mislabeling, not an immediate safety hazard. The product is safe to use but may be mislabeled.
What should I do if I have this product?
Check the product label for the model and lot number. If it matches the recall details, you may need to contact Stryker for further instructions.
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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-0664-2022 (January 21, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0664-2022 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.