FDA recall Z-1804-2026

Product

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.

Reason for recall

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

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

Key facts

Status

Ongoing

Initiation date

2026-03-12

Report date

2026-04-15

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1804-2026