FDA Device recall Z-2463-2023
SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and record…
- FDA Device
- Class II
- ongoing
- Published 2023-09-06
On 2023-09-06 the FDA classified a Class II recall of SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and record… by Stryker, citing potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2463-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-07-10 |
| Published | 2023-09-06 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Stryker |
| Distribution | US |
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;
Reason
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Identifiers
| code_info | GTIN 07613327543094 Software Version: 2.1.8 & 2.20 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2463-2023%22
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