Exact FDA event identifier

Event 92713

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket: July 10, 2023
Product types: Device
Classifications: Class II
Statuses: Ongoing
Recalling firm wording: Stryker Corporation

Dossier provenance

Source snapshots represented here

openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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;

Z-2463-2023

Recall number: Z-2463-2023
Initiated: July 10, 2023
Classification: Class II
Status: Ongoing
Recalling firm: Stryker Corporation
Quantity: 57 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type

Code information

GTIN 07613327543094 Software Version: 2.1.8 & 2.20

Distribution pattern

US Nationwide distribution.