# FDA recall Z-1508-2020

> **Stryker Corporation** · Class II · device recall initiated 2019-09-12.

## 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.

## Distribution

OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea

## Key facts

- **Recall number:** Z-1508-2020
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-09-12
- **Report date:** 2020-03-25
- **Termination date:** 2022-10-31

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1508-2020

## Citation

> AI Analytics. FDA recall Z-1508-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1508-2020. Source: US FDA. Licensed CC0.

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