Data Foundry

Medical device recalls 2015

0210-312-000-Woundcare Replacement kit with soft tip — Class II medical device recall Z-2062-2015

Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2015-07-22, distributed nationwide. Potential sterility breach in the packaging.

Recall numberZ-2062-2015
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Instruments Div. of Stryker Corporation, Portage, MI, United States
Recall initiated2015-05-08
Classified2015-07-13
Reported by FDA2015-07-22
Terminated2015-10-19
DistributedNationwide (US)
Reason classessterility

Product

0210-312-000-Woundcare Replacement kit with soft tip; 0210-318-000; Woundcare Replacement with fan tip; 0210-318-100- Woundcare Replacement Kit; 0210-318-200-Woundcare Replacement with retract coax tip. Accessory to Stryker InterPulse Irrigation System, used for wound debridement, soft tissue debridement, and cleansing of medical, clinical, or surgical sites.

Reason for recall

Potential sterility breach in the packaging.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2062-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.