Severity
Moderate
FDA Devices recall · Reported April 15, 2026
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
Stryker Sustainability Solutions recalled Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bl… - a moderate-severity action.
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bl… was recalled by Stryker Sustainability Solutions in April 15, 2026. Reason: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the …. Check the official notice for the remedy. Verify recall #Z-1804-2026 with the FDA Devices before acting.
The recall
Stryker Sustainability Solutions issued this moderate-severity FDA Devices recall-Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the ….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1804-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1804-2026) was formally reported on April 15, 2026, with the manufacturer initiating the action on March 12, 2026. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Sustainability Solutions is listed as the recalling firm, operating out of Tempe, AZ. Federal records list the affected scope as 56,740 cuffs.
The documented reason for this recall is: Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. Distribution data in the federal record shows the product reached: U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
56,740 cuffs
Related Recalls
6
3 from same agency
Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker Sustainability Solution Color Cuff 18" (Red), Quick Connect Dual Port Single Bladder REF 5921-018-135 Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-235.
Due to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1804-2026 |
| Date reported | April 15, 2026 |
| Date initiated | March 12, 2026 |
| Recalling firm | Stryker Sustainability Solutions |
| Firm location | Tempe, AZ |
| Affected scope | 56,740 cuffs |
| Distribution | U.S.: AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NY, OHJ, OK, OR, PA SC, SD, TN, TX, VA, VT, and WA. O.U.S.: N/A |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported April 15, 2026. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.