Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Ste...
FDA Device Recall #Z-1508-2020 — Class II — September 12, 2019
Recall Summary
| Recall Number | Z-1508-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 12, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Stryker Corporation |
| Location | San Jose, CA |
| Product Type | Devices |
| Quantity | 525 devices |
Product Description
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 Pattern
OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Lot / Code Information
Lot codes: 010318 02 010318 03 010318 04 010318 05 010318 06 010318 07 010318 08 010318 10 010518 01 010518 02 010518 03 010518 04 010518 05 010518 06 010518 07 010518 08 010518 09 010518 10 011819 01 011819 04 011819 06 011819 07 011819 08 011819 09 011819 10 012219 01 012219 02 012219 03 012219 04 012219 05 012219 06 012219 07 012219 08 012219 09 012219 10 012219 12 021018 01 021018 02 021018 03 021018 04 021018 05 021018 07 021018 08 021018 09 021018 10 021018 11 021018 12 021018 13 021018 14 021018 15 021018 16 021018 17 021018 18 021018 19 022718 01 022718 02 022718 03 022718 04 022718 05 022718 06 022718 07 022718 08 022718 09 022718 10 022718 11 022718 12 022718 13 022718 14 022718 15 022718 18 022718 19 022718 20 070618 01 070618 02 070618 03 070618 04 070618 05 070618 06 070618 07 080416 02 080818 09 080818 10 081518 01 081518 02 081518 03 081518 04 081518 06 081518 07 083018 01 083018 02 083018 03 083018 04 083118 02 083118 04 083118 05 083118 07 083118 08 083118 09 083118 10 091318 01 091318 02 091318 03 091318 05 091318 06 091318 07 091318 08 091318 09 101018 01 101018 02 101018 03 101018 04 101018 05 101018 06 101018 07 101018 09 101018 10 110218 01 110218 02 110218 03 110218 04 110218 05 110218 06 110218 08 110218 09 110218 10 110507 02
Other Recalls from Stryker Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1427-2026 | Class II | MOLLI 2 System System includes: MM1000 (Pack ... | Jan 21, 2026 |
| Z-0601-2026 | Class II | NICO BrainPath; Product Number/Product Name ... | Oct 31, 2025 |
| Z-0599-2026 | Class II | NICO Myriad Handpiece Product Number/Product... | Oct 31, 2025 |
| Z-0600-2026 | Class II | NICO Myriad Illumination Pack Product No. NN... | Oct 31, 2025 |
| Z-2277-2025 | Class II | Stryker SmartPump Tourniquet, disposable steril... | Jul 2, 2025 |
Frequently Asked Questions
Contact your physician immediately if you use an electrical device or implant affected by this recall. For external devices (monitors, pumps), stop using the device and contact the manufacturer for a replacement. For implanted devices (pacemakers, ICDs), your cardiologist will assess whether you need device replacement surgery — the decision depends on how dependent you are on the device and the actual failure rate observed in the field. Do not attempt to repair or modify a recalled electrical medical device yourself. Monitor for any new or unusual symptoms and report them to your doctor.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.