Stryker Sustainability Solutions Recall for Tourniquet Cuffs
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Stryker Sustainability Solutions is recalling 56,740 tourniquet cuffs due to a potential detachment issue that could prevent them from maintaining pressure, affecting products distributed across multiple U.S. states.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 23, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
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What Happened
Stryker Sustainability Solutions is recalling certain tourniquet cuffs because of a potential for the cuffs to detach from the bladder at the welding connection, resulting in the cuff not being able to maintain pressure.
Which Products Are Affected
The affected products include: 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 5921-018-235; and Stryker Sustainability Solution Color Cuff 18" (Red) Dual Port Single Bladder REF 5921-018-135. A total of 56,740 cuffs are affected, with specific serial and lot numbers listed in the recall details. These products were distributed to U.S. states including 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, OH, OK, OR, PA, SC, SD, TN, TX, VA, VT, and WA. The recall number is Z-1804-2026.
What You Should Do
Consumers should follow the initial firm notification, which was issued via letter, and contact Stryker Sustainability Solutions for instructions on the recall.
Why This Matters
This recall involves medical devices that could fail to maintain pressure, potentially leading to health risks during use, highlighting the importance of device safety in healthcare settings.
Source
Attribution: FDA Recall Z-1804-2026. For more information, visit the FDA website or search for event ID 98504.
Original source: FDA Official Notice ↗
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