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Use caution Medical device recall · FDA · Published September 12, 2019

Stryker Strykeprobe Outer Sheath Replacement Risk: Potential Electrical Hazard

Stryker recalls 5.0mm x 45cm Strykeprobe outer sheath replacements due to potential electrical hazards from improper seating of the sheath/probe tip.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1509-2020Medical deviceStryker ›
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Recalling firmStryker Corporation5900 Optical Ct · San Jose, CA 95138-1400
✎ GovInfoNow plain-language explainer

Stryker is recalling outer sheath replacements for their 5.0mm x 45cm Strykeprobe electrosurgical probes. The recall is due to a risk that the sheath/probe might not seat properly, which could cause the distal tip to melt and create an electrical hazard for patients. Read more at govinfonow.com/recall/67022-stryker-strykeprobe-outer-sheath-replacement-risk-potential-electrical-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/67022-stryker-strykeprobe-outer-sheath-replacement-risk-potential-electrical-hazard · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1509-2020

Cite this page

“Stryker Strykeprobe Outer Sheath Replacement Risk: Potential Electrical Hazard.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/67022-stryker-strykeprobe-outer-sheath-replacement-risk-potential-electrical-hazard. Based on FDA recall #Z-1509-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1509-2020%22&limit=1).

The FDA announced on 2019-09-12 that Stryker Corporation is voluntarily recalling the Strykeprobe Outer Sheath Replacement due to a potential length difference that could cause insulation failure and unintended electrical flow to patients. GovInfoNow's records show this Class II recall was initiated by the firm.

How to tell if you have it

  • Brand: Stryker
  • Product: Strykeprobe, Outer Sheath Replacement
  • REF: 0250070450
  • Size: 5.0 mm x 45 cm
  • UPC: 07613327051926
  • Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02
  • Distribution: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan, Puerto Rico, South Africa, and South Korea

The hazard

A difference in length between the sheath tube and the sheath/probe could prevent proper seating, potentially causing the distal tip to melt. This melting may compromise insulation, leading to unintentional flow of electricity to the patient.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since 2017-11-17. Recent Stryker recalls include a leaking handpiece reported on 2026-06-08, an electrical shock risk in the Neptune Smart Docking Station noted on 2026-05-06, and nonconforming FluidSmart Urology Tube Sets distributed on 2026-04-09. Other recent recalls of similar products include Wilson-Cook Teslatome Sphincterotomes (2025-12-18), Olympus A2660 Inner Sheath (2025-11-11), and Olympus A2642 Inner Sheath (2025-11-11).

How to tell if you have this one

Check for the Stryker Strykeprobe outer sheath replacement with model numbers 0250070451-PKG, 0250070452-PKG, 0250070453-PKG, or 0250070455-PKG. These were sold with lot numbers 010818-02 through 010818-09 and 040816-01 through 040816-02.

  • Brand
    Stryker
  • Product
    Stryker, REF: 0250070450, 5.0 mm x 45 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01)
  • Category
    Medical device
FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea
Recall numberProduct, codes & lotsQuantity
Z-1508-2020Stryker, 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; 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 02525 devices
Z-1509-2020Stryker, 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; Lot Numbers: 010818-02, 010818-05, 010818-06, 010818-07, 010818-08, 010818-09, 040816-01, 040816-02—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the model number and lot numbers listed in the recall notice to confirm if your item is affected.

Where it went and when

Where it was distributed

Distributed in Puerto Rico, and outside the U.S.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: not listedGAHawaii: not listedHITexas: not listedTXFlorida: not listedFLPuerto Rico: yesPR

FDA distribution: “OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Puerto Rico.

Recall timeline

FDA terminated this recall 3.1 years after the firm started it.

1. Firm started the recall: Sep 12, 201912. FDA classified it Class II: Mar 17, 202023. Published in FDA’s Enforcement Report: Mar 25, 202034. FDA terminated the recall: Oct 31, 2022420192022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1509-2020 (September 12, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1509-2020 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA