Class II — Stryker Corporation
| Recalling firm | STRYKER CORP. |
|---|---|
| Registered facility | View this company's 61 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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 |
| Distribution | OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea |
| Initiated | 2019-09-12 |
| Classified | 2020-03-17 |
| Terminated | 2022-10-31 |
| Recall number | Z-1509-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Stryker Corporation (Z-1509-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/85100/
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