Stryker — Class II medical device recall Z-1508-2020
Terminated recall by Stryker Corporation, reported 2020-03-25, distributed in PR. Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the bas
| Recall number | Z-1508-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2019-09-12 |
| Classified | 2020-03-17 |
| Reported by FDA | 2020-03-25 |
| Terminated | 2022-10-31 |
| Distributed | PR |
| Countries outside the US | CA, CH, CO, ES, JP, KR, NL, TW, ZA |
| Quantity | 525 devices |
| UPC / GTIN / UDI-DI | 07613327051971 |
| Lot numbers | 010318, 010518, 011819, 012219, 021018, 022718, 070618, 080416, 080818, 081518, 083018, 083118, 091318, 101018, 110218, 110507 |
| Model numbers | 0250070460, 5.0 |
Product
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG, StrykeFlow Electrocautery Probe, Ball Tip, 5MM 0250070445-PKG, StrykeFlow Electrocautery Probe, Needle Tip 5MM 0250070446-PKG, StrykeFlow Electrocautery Probe, Spoon Tip, 5MM
Reason for recall
Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately.
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-1508-2020. 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.