SURGICOUNT 0694002090Recalls & reported problems
Stryker Corporation · + APPLICATION · Class 1
All models of SURGICOUNT (20)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 2
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
2 FDA recall records name this device's identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Recalls naming this device
- Jul 10, 2023Class IIOpen, Classified
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
Z-2463-2023 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 15, 2022Class IITerminated
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.
Z-1452-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Other Counter, sponge, surgical devices
- Situate 01-0031Covidien LP · Counter, sponge, surgical97 reports
- Situate 01-0043Covidien LP · Counter, sponge, surgical94 reports
- Situate 01-0034Covidien LP · Counter, sponge, surgical67 reports
- Situate 01-0035Covidien LP · Counter, sponge, surgical18 reports
- Situate 01-0046Covidien LP · Counter, sponge, surgical10 reports
- N/A 0794001010Stryker Corporation · Counter, sponge, surgical7 reports
- SurgiCount 0894000005Stryker Corporation · Counter, sponge, surgical6 reports
- Situate 01-0043RCovidien LP · Counter, sponge, surgical5 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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