Z-2277-2025Class II

Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP...

Name: Z-2277-2025 Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP...
Creator: Stryker Corporation
Published: 2025-07-02
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2025-07-02 / Open, Classified / root cause: manufacturing process

FDA source

Stryker Corporation began a recall of Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP... on 2025-07-02. FDA classified it as Class II and gives the reason as "Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2277-2025
Classification: Class II
Status: Open, Classified
Initiated: 2025-07-02
Posted: 2025-08-07
Recalling firm: Stryker Corp.
Product: Stryker SmartPump Tourniquet, disposable sterile (single use) DISP 18X3,1BLA,1PRT QUICK / 5921-018-135; DISP 18X3,1BLA,2PRT QUICK / 5921-018-235; DISP 24X4,1BLA, 2PRT QUICK / 5921-024-235
Product code: KCY Tourniquet, Pneumatic
Reason for recall: Tourniquet cuff flange may become detached from the bladder. If leak occurs during the procedure, there may be risk of hemorrhage, resulting in blood loss greater than expected. Other serious risks include cerebral hypotension and cardiovascular collapse and arrest, risking stroke or death. Specific to IVRA, patient toxicity may also occur due to rapid systemic absorption of anesthetics.
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: On July 2, 2025, the firm notified customers via Urgent Medical Device Recall letters. Customers were instructed to locate and quarantine any affected products at their facility and return an enclosed business reply form to the firm. Stryker will provide a shipping label to return the affected product, and credit will be issued to affected customers upon receipt of the recalled product.
Quantity in commerce: 233.230
Distribution: Domestic US distribution nationwide. International distribution to Australia Canada Hong Kong India Malaysia Netherlands New Zealand Singapore Sweden Thailand United Kingdom
Product codes and lots: 5921-018-135 GTIN 07613154599257 5921-018-235 GTIN 07613154599295 5921-024-235 GTIN 07613154599370

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2277-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2277-2025	Class II	Ongoing	Voluntary: Firm initiated	2025-08-13	2025-08-07

Product code KCY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)