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Use caution Medical device recall · FDA · Published April 6, 2026

Stryker INZONE Detachment System: Premature Battery Drain Risk

Stryker recalls INZONE Detachment System devices with premature battery drain causing failure to power on or detach coils, potentially requiring medical intervention.

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

🇺🇸 FDA recall #Z-2552-2026Medical deviceStryker ›
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Contact the company

Recalling firmStryker Neurovascular47900 Bayside Pkwy · Fremont, CA 94538-6515
✎ GovInfoNow plain-language explainer

Stryker is recalling certain INZONE Detachment System devices that may experience premature battery drain. This can cause the device to fail to power on, show faint indicators, or be unable to detach coils, which might require medical intervention if the procedure must continue. Read more at govinfonow.com/recall/49540-stryker-inzone-detachment-system-premature-battery-drain-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/49540-stryker-inzone-detachment-system-premature-battery-drain-risk · Updated August 18, 2026 · FDA enforcement record: FDA #Z-2552-2026

Cite this page

“Stryker INZONE Detachment System: Premature Battery Drain Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/49540-stryker-inzone-detachment-system-premature-battery-drain-risk. Based on FDA recall #Z-2552-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2552-2026%22&limit=1).

The FDA announced on April 6, 2026, that Stryker Neurovascular is recalling the INZONE DETACHMENT SYSTEM due to premature battery drain. This defect may cause devices to fail to power on or detach coils as intended, potentially necessitating medical intervention.

How to tell if you have it

  • Brand: Stryker
  • Product: INZONE DETACHMENT SYSTEM
  • REF: M00345100950
  • UDI-DI: 04546540697950
  • Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985

The hazard

The devices may experience premature battery drain causing them to not power on, power on with faint indicators, or be unable to detach a coil as intended. This failure may necessitate medical intervention if the procedure must be completed with an alternative technique.

Context

GovInfoNow's records show Stryker Neurovascular has 16 other recalls on record since June 26, 2017. Other recent recalls of similar products include Stryker BARD Dynamic XT Deca Steerable Catheter Recall (April 10, 2026), Stryker Daig Livewire Steerable Catheter Recall (April 10, 2026), and Stryker BARD Dynamic Tip Steerable Recall (April 10, 2026).

How to tell if you have this one

Check for the model reference M00345100950 on the device. The recall includes specific lots listed in the UDI-DI code 04546540697950.

  • Brand
    Stryker
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Device Status

    Verify if the device powers on normally with clear audible and visual indicators.

  2. Contact Manufacturer

    Reach out to Stryker Neurovascular for guidance on whether the device needs replacement or repair.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 47 states.

Alaska: named in the noticeAKMaine: named in the noticeMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: named in the noticeNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: named in the noticeWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: named in the noticeORNevada: named in the noticeNVWyoming: nationwideWYSouth Dakota: named in the noticeSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: nationwidePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: named in the noticeNEMissouri: named in the noticeMOKentucky: named in the noticeKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: named in the noticeMDDelaware: named in the noticeDEArizona: named in the noticeAZNew Mexico: named in the noticeNMKansas: named in the noticeKSArkansas: named in the noticeARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: named in the noticeSCDistrict of Columbia: named in the noticeDCOklahoma: named in the noticeOKLouisiana: named in the noticeLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR,…” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, South Carolina, South Dakota, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 3 months after the firm started it.

1. Firm started the recall: Apr 6, 202612. FDA classified it Class II: Jun 24, 202623. Published in FDA’s Enforcement Report: Jul 1, 202632026
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-2552-2026 (April 6, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2552-2026 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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