Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF 5921-024-235 Stryker

FDA device recall Z-1804-2026 · posted 2026-04-09 · Open, Classified

Recall details

Recalling firm

Stryker Sustainability Solutions

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.

Action taken

On 03/12/2026, the firm sent via certified mail an "URGENT: Medical Device Recall" letter informing customers that there is a potential for Tourniquet Cuffs flange to detach from the bladder where the welding connection is, which may result in the cuff not able to maintain pressure. Customers are instructed to: 1. Inform individuals within their organization who need to be aware of this action. 2. Check their internal inventory to locate the affected product. Segregate the affected products, quarantine and discontinue use. 3. Complete the Business Reply Form (Attachment B) and return the completed via email to SSSPFA@stryker.com, or use the QR Code on Attachment B. Response is required. a. If customers have indicated that product remains in their inventory, a prepaid shipping label will be issued for the return of the product. Credit will be issued to their facility for products returned upon receipt. 4. Maintain awareness of this communication internally until all required actions have been completed within their facility. For any additional information or questions please reach out to SSSPFA@stryker.com or Stryker Customer Service at 800-624-4422.

Root cause

Nonconforming Material/Component

Status

Open, Classified

Product code

KCY

Quantity affected

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

Date initiated

2026-03-12

Date posted

2026-04-09

Location

Tempe, AZ