FDA Device recall Z-1509-2020
Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This pr…
- FDA Device
- Class II
- terminated
- Published 2020-03-25
On 2020-03-25 the FDA classified a Class II recall of Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051926 This pr… by Stryker, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1509-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-09-12 |
| Published | 2020-03-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker |
| Distribution | PR |
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
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.
Identifiers
| code_info | Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2020%22
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