Stryker — Class II medical device recall Z-1509-2020
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-1509-2020 |
|---|---|
| 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 |
| UPC / GTIN / UDI-DI | 07613327051926 |
| Lot numbers | 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02 |
| Model numbers | 0250070450, 5.0 |
Product
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This products was distributed with the following sheath/probe: 0250070451-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Spatula-Tip, 0250070452-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, J-TIP, 0250070453-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, L-TIP, 0250070455-PKG, 5MM X 45CM StrykeProbe Electrosurgical Probe, Needle Tip
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-1509-2020. 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.