Z-1452-2022Class II

SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting...

Name: Z-1452-2022 SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting...
Creator: Stryker Instruments Div. of Stryker Corporation
Published: 2022-06-15
License: https://open.fda.gov/license/

Stryker Corp. / initiated 2022-06-15 / Terminated / root cause: software

FDA source

Stryker Instruments Div. of Stryker Corporation began a recall of SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of... on 2022-06-15. FDA classified it as Class II and gives the reason as "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 software update will prevent the...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-1452-2022
Classification: Class II
Status: Terminated
Initiated: 2022-06-15
Posted: 2022-07-22
Terminated: 2024-04-05
Recalling firm: Stryker Corp.
Product: SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting, displaying, recording and locating the number of RFID-tagged absorbent articles used during surgical procedures.
Product code: LWH Counter, Sponge, Surgical
Reason for recall: 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 software update will prevent the occurrence of this error.
Root cause tag: software
FDA root cause: Under Investigation by firm
Action: Urgent Notification Software Update Notification letters dated June 2022 were sent to customers. Stryker Instruments will be updating the software on all SurgiCount+ Tablets (0794-001-010) distributed on or before May 1, 2022. Actions to be Taken 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. A local Stryker representative will schedule and perform the software update on each SurgiCount+ Tablet. A form, documenting the software update, will be completed by the Stryker Sales Representative, and a copy will be provided to your facility. 3. Please complete the enclosed Business Reply Form to confirm receipt of this notification. Return to [email protected]. 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.
Quantity in commerce: 44 units
Distribution: The products were distributed to the following US states: KS and ME.
Product codes and lots: 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 GK404E00287 211071 211115 211265

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1452-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1452-2022	Class II	Terminated	Voluntary: Firm initiated	2022-07-27	2022-07-21

Product code LWH

K060076Class ISurgicount Safety-Sponge SystemSurgicount Medical / cleared 2006-03-14

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)