Stryker Camera Control Unit Recalled Due to Inverted Image Display Defect
Stryker is recalling the 1688 Camera Control Unit due to a software defect that causes the surgical monitor image to flip upside-down. This could lead to surgeon error or the need for additional surgical intervention.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II device recall with no reported injuries or hospitalizations. The defect creates a theoretical risk of serious surgical complications through image inversion during procedures. Per the rubric, recalls with no reported illness and theoretical hazards score at most 3, placing this in the High category.
Plain-English summary
Stryker Corporation is recalling the 1688 Camera Control Unit (CCU), Catalog number 1688010000. This device is used in laparoscopic, endoscopic, and arthroscopic surgical procedures worldwide, including throughout the United States and Puerto Rico.
A software defect in the camera control unit causes the monitor image to display upside-down and in an incorrect orientation during use. This image inversion could cause surgeons to misidentify anatomical landmarks or tissue locations, potentially leading to surgical complications.
The potential harms associated with this defect include conversion to open surgery, additional medical interventions, or revision surgery. Approximately 11,955 units have been distributed globally. The defect affects software revisions 3.0.6, 4.0.13, and 4.0.18. Facilities and surgeons should contact Stryker immediately for repair or replacement options.
No injuries or illnesses have been reported in connection with this defect.
The recalled product
- 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.
- Manufacturer
- Stryker Corporation
- Affected units
- 11,955
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- All serial numbers of 1688 CCU
- UDI: 07613327420081
- with Software Revisions: 3.0.6
- 4.0.13
- and 4.0.18
Distribution
Related recalls
Same manufacturer · Stryker Corporation
See all →- HighStryker Ahto Tube Set Recalled for Handpiece Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighStryker Single Spike Tube Set Recalled for Leaking During Use
FDA (Devices) · 2026-08-12
- SevereStryker AHTO Tube Set Packaging Recalled for Handpiece Leaking
FDA (Devices) · 2026-08-12
Same hazard · software defect
See all →- ModerateIntelerad IntelePACS Software Recalled for Image Display Mismatch
FDA (Devices) · 2026-10-21
- HighPhilips Spectral CT Systems Recalled for Software Issues Affecting Safety
FDA (Devices) · 2026-10-14
- ModerateSteris HexaVue Focus Integration System Recalled for Patient Data Mismatch
FDA (Devices) · 2026-10-14
- ModerateBeckman Coulter Recalls DxC 500i Clinical Analyzer Modules Due to Software Error
FDA (Devices) · 2026-10-14
- ModerateUnited Imaging uMI Panvivo S PET/CT Systems Recalled for Software Defect
FDA (Devices) · 2026-10-07
Similar recalls
- ModerateStryker Recalls 1488 HD 3-Chip Cameras Due to Colored Screen Image
FDA (Devices) · 2014-12-17
- ModerateStryker 1488 HD 3-Chip Inline Camera Recalled for Colored Screen Image
FDA (Devices) · 2014-12-17
- ModerateStryker 1488 HD 3-Chip Camera Recall for Colored Screen Image
FDA (Devices) · 2014-12-17
- ModerateStryker USB Converter in Mako Robotic Surgery System May Fail
FDA (Devices) · 2022-09-21
- ModerateStryker Endoscopy Recalls Laparoscopic Manual Instruments Due to Sterilization Documentation Error
FDA (Devices) · 2014-12-24
- HighPhilips Allura Xper Medical Imaging Systems Recalled for Shutter Reset Issue
FDA (Devices) · 2018-08-01