Z-2463-2023Class II

SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of...

Name: Z-2463-2023 SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of...
Creator: Stryker Corporation
Published: 2023-07-10
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2023-07-10 / Open, Classified / root cause: software

FDA source

Stryker Corporation began a recall of SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of... on 2023-07-10. FDA classified it as Class II and gives the reason as "Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2463-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-10
Posted: 2023-08-25
Recalling firm: Stryker Corp.
Product: SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and recording the number of RFID-tagged absorbent articles used during surgical procedures Product Code: 0694-002-090;
Product code: PVZ Non-Stainless Steel Needle
Reason for recall: Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Stryker issued Urgent Medical Device Correction Letter addressed to: IT Director, Materials Manager, Risk Manager, OR Director, OR Coordinator sent July 10, 2023 via 2-day Fed'X delivery. Letter states reason for recall, health risk and action to take: 1. Immediately review this software update notification. Advise OR staff, and all other personnel who may use this product, of the information in the notification. 2. Ensure all Stryker surgical tablets using Surgicount+ software is connected to the local facility Wi-Fi so that the software update can be automatically transmitted. Press INSTALL once the update notification appears on the tablet to complete the update. Contact your local sales representative or technical support at 1-800-253-3210 for any assistance or questions. 3. Sign and return the enclosed Business Reply Form to [email protected]. 4. Maintain awareness of this communication internally and inform Stryker if any of the subject devices have been distributed to other organizations. If so, provide contact details so Stryker can inform the recipients accordingly. We apologize for any inconvenience this action may cause your facility. Please forward a copy of this letter to any other personnel within your facility that you deem appropriate. Please contact Jordan Anderson at (269) 800-1347 or [email protected] with questions or concerns.
Quantity in commerce: 57 units
Distribution: US Nationwide distribution.
Product codes and lots: GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2463-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2463-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-09-06	2023-08-25

Product code PVZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)