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Use caution Medical device recall · FDA · Published June 15, 2022

Stryker SurgiCount+ Software Version 2.0.17: Duplicate Sponge Counting Error Risk

Stryker recalls SurgiCount+ software version 2.0.17 due to potential duplicate sponge counting errors during surgery. This could lead to retained surgical sponges if not corrected. Update to prevent the error.

🇺🇸 FDA recall #Z-1452-2022Medical deviceStryker ›
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Recalling firmStryker Instruments Div. of Stryker Corporation4100 E Milham Ave · Portage, MI 49002-9704
✎ GovInfoNow plain-language explainer

Stryker is recalling a specific software version of their SurgiCount+ system used in surgeries. The software could count a sponge twice, potentially leading to a sponge being left inside a patient after surgery. This is serious because retained surgical sponges can cause infections or other complications. Read more at govinfonow.com/recall/60503-stryker-surgicount-software-version-2-0-17-duplicate-sponge-counting.

Source Summary by GovInfoNow · govinfonow.com/recall/60503-stryker-surgicount-software-version-2-0-17-duplicate-sponge-counting · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1452-2022

Cite this page

“Stryker SurgiCount+ Software Version 2.0.17: Duplicate Sponge Counting Error Risk.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/60503-stryker-surgicount-software-version-2-0-17-duplicate-sponge-counting. Based on FDA recall #Z-1452-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1452-2022%22&limit=1).

The FDA announced on June 15, 2022, that Stryker Instruments Div. of Stryker Corporation is recalling the SurgiCount+ System Application due to a software error that may allow duplicate sponges to be counted without prompting a case note. The agency said the recall addresses a Class II hazard in surgical counting devices.

How to tell if you have it

  • Stryker
  • SurgiCount+ System Application, Software Version 2.0.17
  • Catalog Number 0694-002-090
  • UDI-DI (GTIN): 07613327543094
  • Serial Numbers: GK404E00828, GK404E00933, GK404E00959, GK404E01157, GK405E00282, GK405E00642, GK405E00671, GK405E00675, GK405E00693, GK405E00707, GK405E00757, GK405E00827, GK405E00857, GK405E00914, GK403E00537, GK404E00494, GK405E00176, GK405E00655, GK405E00723, GK403E00031, GK404E00638, GK404E00640, GK404E00700, GK404E00866, GK404E00887, GK404E00945, GK404E01113, GK404E01119, GK404E01121, GK404E01123, GK404E01170, GK404E01171, GK405E00602, GK49CE00058, GK404E00032, GK404E00034, GK404E00043, GK404E00262, GK404E00287, 211071, 211115, 211265

The hazard

GovInfoNow's records show that when scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The recall states that the software update will prevent the occurrence of this error.

Context

GovInfoNow's records show Stryker Instruments Div. of Stryker Corporation has had 11 other recalls on record since 2017-10-16. Other recent recalls include the Stryker Zyphr Disposable Cranial Perforator (2020-10-16) and the Stryker Neptune E-SEP 165mm Blade Electrode (2020-03-26). The company also issued a recall for Triton Canister Scanning Labels on 2020-01-22 regarding blood loss estimation risk.

How to tell if you have this one

Check for the software version 2.0.17 with catalog number 0694-002-090. The system uses specific serial numbers listed in the recall notice. This version was sold to hospitals and surgical teams.

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

What to do — step by step

  1. Update Software

    Install the software update to prevent duplicate sponge counting errors.

Where it went and when

Where it was distributed

Distributed in Kansas and Maine.

Alaska: not listedAKMaine: yesMEVermont: 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: yesKSArkansas: 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 listedFL

FDA distribution: “The products were distributed to the following US states: KS and ME.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Kansas, Maine.

Recall timeline

FDA terminated this recall 22 months after the firm started it.

1. Firm started the recall: Jun 15, 202212. FDA classified it Class II: Jul 21, 202223. Published in FDA’s Enforcement Report: Jul 27, 202234. FDA terminated the recall: Apr 5, 2024420222024
  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-1452-2022 (June 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1452-2022 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