STRYKER PKG — Class II medical device recall Z-2865-2026
Ongoing recall by Stryker Corporation, reported 2026-08-12, distributed nationwide. There has been an increased amount in reported complaints consistently describing leaking from the handpiece d
| Recall number | Z-2865-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2026-06-08 |
| Classified | 2026-08-03 |
| Reported by FDA | 2026-08-12 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BR, CA, CH, CL, DE, ES, FR, GB, ID, IT, KR, MX, NL, NZ, PH, SE, TW |
| Quantity | 11,857 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 07613327061352 |
| Lot numbers | 24260FG2, 24261FG2, 24297FG2, 24298FG2, 24299FG2, 24302FG2, 24340FG2, 24341FG2, 25008FG2, 25009FG2, 25010FG2, 25011FG2, 25024FG2, 25034FG2, 25035FG2, 25052FG2, 25063FG2, 25064FG2, 25084FG2, 25092FG2, 25093FG2, 25121FG2, 25134FG2, 25135FG2, 25153FG2, 25154FG2, 25167FG2, 25182FG2, 25183FG2, 25216FG2, 25217FG2, 25245FG2, 25274FG2 |
| Model numbers | 0250070530 |
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Reason for recall
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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-2865-2026. 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.