Stryker — Class II medical device recall Z-2171-2025
Ongoing recall by Stryker Corporation, reported 2025-07-30, distributed nationwide. Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pa
| Recall number | Z-2171-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2025-06-18 |
| Classified | 2025-07-23 |
| Reported by FDA | 2025-07-30 |
| Distributed | Nationwide (US) |
| Countries outside the US | AR, CA, CN, JP, KR, MX, PH, SG |
| Reason classes | packaging, device malfunction |
| UPC / GTIN / UDI-DI | 07613327061369 |
| Model numbers | 0250070520 |
Product
Stryker, StrykeFlow REF: 0250070520 / 2, Disposable Suction/Irrigator with Disposable Tip
Reason for recall
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
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-2171-2025. 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.