# FDA recall Z-0728-2022

> **Stryker Corporation** · Class II · device recall initiated 2022-01-14.

## 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.

## Distribution

Worldwide distribution. US nationwide including Puerto Rico.      OUS: BR, AE, NL, IN, FR, ES, HK, IT, GB, CO, PE, MY, TH, CA, JP, MX, AR, NP, SG, PH, ZA, CL, KR, CN

## Key facts

- **Recall number:** Z-0728-2022
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-01-14
- **Report date:** 2022-03-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0728-2022

## Citation

> AI Analytics. FDA recall Z-0728-2022. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0728-2022. Source: US FDA. Licensed CC0.

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