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Use caution Medical device recall · FDA · Published January 29, 2021

Stryker S-Series Equipment Management System Recall: Risk of Touch Controls Disengaging

Stryker recalls S-Series Equipment Management System models with capacitive touch controls that may disengage when electrocautery devices are used, posing a risk of equipment malfunction during medical procedures.

🇺🇸 FDA recall #Z-1297-2021Medical deviceStryker ›
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Recalling firmStryker Communications571 Silveron Blvd · Flower Mound, TX 75028
✎ GovInfoNow plain-language explainer

What happened, in plain English

Stryker is recalling specific S-Series Equipment Management System models due to a risk that capacitive touch controls could disengage when an electrocautery device is in use. This could lead to equipment malfunction during medical procedures, potentially affecting patient safety. Read more at govinfonow.com/recall/63330-stryker-s-series-equipment-management-system-recall-risk-of-touch.

Source Summary by GovInfoNow · govinfonow.com/recall/63330-stryker-s-series-equipment-management-system-recall-risk-of-touch · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1297-2021

Cite this page

“Stryker S-Series Equipment Management System Recall: Risk of Touch Controls Disengaging.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63330-stryker-s-series-equipment-management-system-recall-risk-of-touch. Based on FDA recall #Z-1297-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1297-2021%22&limit=1).

Why it’s dangerous

The capacitive touch controls on the S-Series Equipment Management System may disengage when an electrocautery device is in use. This disengagement could cause the equipment to malfunction during medical procedures, potentially affecting patient safety.

Who’s affected

Healthcare professionals using Stryker S-Series Equipment Management Systems with the affected model numbers are most at risk. Patients undergoing procedures involving electrocautery devices may be impacted if the equipment malfunctions.

How to tell if you have this one

Check for model numbers 0682400550 and specific component serial numbers listed in the recall notice. The affected items include components like P38198, P38199, P40553, P40554, and P46269 with serial numbers 2258046 and 2863490.

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

What to do — step by step

  1. Check Equipment Model

    Verify the model number on your S-Series Equipment Management System to see if it matches the recalled model numbers listed in the recall notice.

  2. Contact Stryker

    Reach out to Stryker Communications for guidance on the specific components affected and any necessary actions.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 42 states.

Alaska: named in the noticeAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: named in the noticeIDMontana: named in the noticeMTNorth Dakota: nationwideNDMinnesota: 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: named in the noticeWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: named in the noticeINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: named in the noticeCTCalifornia: named in the noticeCAUtah: nationwideUTColorado: 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: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: 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 distribution - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA,…” 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, District of Columbia, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, West Virginia, Wisconsin, Wyoming.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Jan 29, 202112. FDA classified it Class II: Mar 24, 202123. Published in FDA’s Enforcement Report: Mar 31, 202132021
  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-1297-2021 (January 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1297-2021 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