Stryker Corporation: Medical Device Recall in 2022 - (Recall #: Z-0728-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: January 14, 2022

Date Posted: March 16, 2022

Recall Number: Z-0728-2022

Event ID: 89515

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.

Status: Ongoing

Product Quantity: 11,955

Code Information:

All serial numbers of 1688 CCU, UDI: 07613327420081, with Software Revisions: 3.0.6, 4.0.13, and 4.0.18

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated