Skip to content
Lower risk Medical device recall · FDA · Published July 10, 2023

Stryker SurgiCount+ Software May Miscount Sponges - Recall

Stryker recalls SurgiCount+ software version 2.1.8 and 2.20 that may miscount sponges during surgery due to scanning multiple sponges from the same pack type.

🇺🇸 FDA recall #Z-2463-2023Medical deviceStryker ›
Take action

Contact the company

Recalling firmStryker Corporation1941 Stryker Way · Portage, MI 49002-9711
✎ GovInfoNow plain-language explainer

Stryker is recalling SurgiCount+ software versions 2.1.8 and 2.20 that may miscount sponges when scanning multiple items from the same sponge pack type. This could lead to incorrect counts during surgical procedures, potentially causing sponges to be left inside patients. Read more at govinfonow.com/recall/57730-stryker-surgicount-software-may-miscount-sponges-recall.

Source Summary by GovInfoNow · govinfonow.com/recall/57730-stryker-surgicount-software-may-miscount-sponges-recall · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2463-2023

Cite this page

“Stryker SurgiCount+ Software May Miscount Sponges - Recall.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/57730-stryker-surgicount-software-may-miscount-sponges-recall. Based on FDA recall #Z-2463-2023 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2463-2023%22&limit=1).

The FDA announced on July 10, 2023, that Stryker Corporation voluntarily recalled SurgiCount+ Software Applications due to a potential for miscounting sponge products. The agency issued recall number Z-2463-2023 for the Class II device distributed nationwide.

How to tell if you have it

  • Stryker SurgiCount+ Software Application, UPC 07613327543094
  • Product Code 0694-002-090
  • Software Versions 2.1.8 and 2.20

The hazard

The software may miscount when scanning multiple sponge products from the same unique sponge-pack type, according to the FDA. The recall involves 57 units distributed across the United States.

Context

GovInfoNow's records show Stryker Corporation has 34 other recalls on record since November 17, 2017. Recent Stryker recalls include a June 8, 2026, notice for irrigators leaking during use and a May 6, 2026, recall of Neptune Smart Docking Stations for electrical shock risk. Other recent recalls of similar products include Cardinal Health Presource Kits recalls dated July 14, 2026, and Medline Surgical Packs recalled on January 7, 2026.

How to tell if you have this one

Check for software versions 2.1.8 or 2.20 on the SurgiCount+ application. The product code is 0694-002-090 and GTIN is 07613327543094.

  • Brand
    Stryker
  • Product
    SurgiCount+ Software Application
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Update Software

    Update to the latest software version to fix the counting issue.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 58 days after the firm started it.

1. Firm started the recall: Jul 10, 202312. FDA classified it Class II: Aug 25, 202323. Published in FDA’s Enforcement Report: Sep 6, 202332023
  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.

Similar recalls

Latest medical device recalls

Keep exploring

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-2463-2023 (July 10, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2463-2023 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