Spy-Phi Drape — Class II medical device recall Z-1925-2020
Ongoing recall by Stryker Corporation, reported 2020-05-13, distributed nationwide. Sterile drapes packaged in an unsealed pouch.
| Recall number | Z-1925-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2020-01-07 |
| Classified | 2020-05-07 |
| Reported by FDA | 2020-05-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, BE, CA, CH, CL, CN, CO, CZ, DE, DK, ES, FI, FR, GB, GR, HK, IE, IL, IN, IT, JP, KR, MY, NL, NZ, PH, PL, QA, RO, RU, SE, SG, TH, TR, TW, ZA |
| Quantity | 26,298 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 10858701006282, 10858701006329 |
| Lot numbers | 1701X, 1702X, 1703011, 1703021, 1703031, 1703041, 1703051, 1703061, 1703071, 1703081, 1703091, 1703101, 1703111, 1703121, 1703131, 1703141, 1703151, 1703161, 1703171, 1703181, 1703191, 1703201, 1703211, 1703221, 1703231, 1703241, 1703251, 1703261, 1703271, 1703281, 1703291, 1703301, 1703311, 1703X, 1704011, 1704021, 1704031, 1704041, 1704051, 1704061 and 262 more |
Product
Spy-Phi Drape (HH2000) sold as a Spy-Phi Pack (HH9006). Only sold in the US. Drape/ UDI: HH2000/10858701006329; HH9006/ 10858701006282
Reason for recall
Sterile drapes packaged in an unsealed pouch.
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-1925-2020. 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.