Stryker 1488 HD 3-Chip Inline Camera Recalled for Colored Screen Image
Stryker Endoscopy is recalling 1,965 HD 3-Chip Inline Cameras because a colored screen image may occur in certain operating room environments.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a visual defect (colored screen image) without reporting any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Endoscopy is recalling 1,965 units of the 1488 HD 3-Chip Inline Camera, Model Number 1488-710-105. The recall is due to a defect where a colored screen image occurs with the cameras in certain operating room environments. The affected cameras were manufactured during a specific time period.
The 1488 HD 3-Chip Inline Camera is a high-definition camera used to view endoscopic surgical sites on video monitors and capture still and video images. It is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope, endoscope, or arthroscope is indicated for use.
The affected cameras were distributed worldwide, including in the United States, Australia, and Japan. Specific serial numbers for the affected units are listed in the official recall documentation. Healthcare facilities and users should check their inventory against the provided serial numbers and contact Stryker Endoscopy for instructions on how to proceed.
The recalled product
- Product
- 1488 HD 3-Chip Inline Camera; Model Number 1488-710-105 - HD 3-Chip Inline Camera, C-Mount; Product Usage: High definition camera to view endoscopic surgical sites on video monitors and capture still and video images of endoscopic surgical applications. Indicated for use…
- Manufacturer
- Stryker Endoscopy
- Hazard
- Affected units
- 1,965
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 (2)
- Model 1488-710-105: 1488 HD 3-Chip Camera head
- C-Mount
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Endoscopy under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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