1488 HD 3-Chip Camera
Medical device recall Z-0569-2015. Published in FDA’s Enforcement Report on Dec 17, 2014.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Dec 17, 2014. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 1965 cameras how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“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.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
1488 HD 3-Chip Camera; Model Number 1488-210-105 - 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 in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use.
1965 cameras, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Model 1488-210-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12D020574 12D020584 12D020594 12D020614 12D020624 12D020634 12D020704 12D020714 12D020734 12E036114 12E036124 12E036134 12E036144 12E036154 12E036164 12E036174…
Every code shown here, 1,993 characters
Model 1488-210-105: 1488 HD 3-Chip Camera head, C-Mount; Serial numbers: 12D020574 12D020584 12D020594 12D020614 12D020624 12D020634 12D020704 12D020714 12D020734 12E036114 12E036124 12E036134 12E036144 12E036154 12E036164 12E036174 12E036184 12E036204 12E036214 12E036244 12E036254 12E036264 12E036274 12E036284 12E036294 12E036314 12E036324 12E036334 12E036354 12E036374 12E036384 12E036394 12E036404 12E036414 12E036434 12E036444 12E036454 12E038334 12E038344 12E038354 12E038364 12E038374 12E038384 12E038394 12E038404 12E038414 12E038674 12E038684 12E038714 12E038724 12E038754 12E038764 12E039074 12E039084 12E039094 12E039104 12E039114 12E039124 12E039154 12E039164 12E039184 12E039194 12E039204 12E039214 12E039234 12E039244 12E039254 12E039274 12E039284 12E039294 12E039324 12E039334 12E039344 12E039364 12E040514 12E040524 12E040534 12E040544 12E040564 12E040584 12E040594 12E040604 12E040624 12E040634 12E040644 12E040654 12E040694 12E040714 12E040724 12E040744 12E040764 12E040774 12E040804 12E040814 12E041624 12E041644 12E041654 12E043194 12E043204 12E043234 12E043244 12E043264 12E043274 12E043294 12E043304 12E043314 12E043324 12E043344 12E043364 12E047664 12E047674 12E047684 12E047724 12E047734 12E047744 12E047774 12E047784 12E047794 12E047804 12E047834 12E050174 12E050184 12E050194 12E050204 12E050244 12E050274 12E050284 12E050294 12E050304 12E050314 12E050334 12E050444 12E050454 12E050474 12E050484 12E050504 12E050544 12E050554 12E050564 12E050574 12E050594 12E050614 12E055784 12E055814 12E055824 12E055834 12E055844 12E055864 12E055884 12E055894 12E055914 12E055944 12E055964 12F000014 12F000044 12F000064 12F000094 12F000104 12F000124 12F000134 12F000144 12F000154 12F000174 12F000194 12F000204 12F000224 12F000234 12F000244 12F000254 12F000264 12F000284 12F000294 12F000304 12F000314 12F000324 12F000334 12F000354 12F000364 12F000384 12F000414 12F001764 12F001784 12F001794 12F001814 12F001824 12F001834 12F001854 12F001864 12F001874 12F001884 12F001894 12F001904…
FDA’s list runs to 16,412 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide Distribution - US Nationwide in the states of Australia and Japan
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Mar 5, 2013.
- FDA classified it on Dec 9, 2014.
- FDA’s Enforcement Report published it on Dec 17, 2014.
- FDA terminated it on Dec 10, 2014.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Stryker Endoscopy, of San Jose, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 16,412 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.