1688 Camera Control Unit — Class II medical device recall Z-0728-2022
Ongoing recall by Stryker Corporation, reported 2022-03-16, distributed nationwide. A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down int
| Recall number | Z-0728-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, San Jose, CA, United States |
| Recall initiated | 2022-01-14 |
| Classified | 2022-03-07 |
| Reported by FDA | 2022-03-16 |
| Distributed | Nationwide (US) |
| Quantity | 11,955 |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 07613327420081 |
| Serial numbers | 1688CCU |
| Model numbers | 1688010000 |
Product
1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is used.
Reason for recall
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical intervention, or a revision surgery.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0728-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.