1488 HD 3-Chip Camera
Medical device recall Z-0571-2015. 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 1488-610-122 - HD 3-Chip Camera Head with Integrated Coupler. 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 1488-610-122: 1488 HD 3-Chip Camera Head with Integrated Coupler. Serial numbers: 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974…
Every code shown here, 1,998 characters
Model 1488-610-122: 1488 HD 3-Chip Camera Head with Integrated Coupler. Serial numbers: 12D030204 12D030214 12D030224 12F060834 12F060844 12F060854 12F060874 12F060894 12F060904 12F060914 12F060924 12F060934 12F060954 12F060964 12F060974 12F060984 12F060994 12F061024 12F061054 12F061064 12F061074 12F061084 12F061094 12F061104 12F061114 12F061134 12F061154 12F061164 12F061174 12F061184 12F061194 12F061234 12F061264 12F061274 12F061294 12F061304 12F061314 12F061324 12H001234 12H001244 12H001254 12H001264 12H001274 12H001284 12H001294 12H001304 12H001324 12H038814 12H038824 12H038834 12H038844 12H038854 12H038864 12H038874 12H038894 12H059034 12H059044 12H059054 12H059084 12H059094 12H059104 12H059124 12I004814 12I004834 12I004844 12I004854 12I004864 12I004874 12I004884 12I004894 12I004904 12I004914 12I004954 12I004994 12I005004 12I005014 12I005024 12I005044 12I005054 12I005064 12I005074 12I005084 12I005094 12I005104 12I014974 12I014984 12I014994 12I015004 12I015014 12I015024 12I015034 12I015044 12I015054 12I015064 12I016374 12I016384 12I016394 12I016404 12I016414 12I016424 12I016434 12I016444 12I016454 12I016464 12I016474 12I016484 12I016494 12I016504 12I016514 12I016524 12I016534 12I016544 12I016554 12I016564 12I018674 12I018684 12I018694 12I018704 12I018714 12I018724 12I018734 12I018744 12I018754 12I018764 12I018774 12I018784 12I018794 12I018804 12I018814 12I018824 12I018834 12I018844 12I018854 12I018864 12I018874 12I018884 12I018894 12I018904 12I018914 12I018924 12I018934 12I018944 12I019254 12I019264 12I019274 12I019284 12I019294 12I019304 12I019314 12I019324 12I019334 12I019344 12I033824 12I033874 12I033894 12I033904 12I033914 12I033924 12I033934 12I033944 12I033954 12I033964 12I033974 12I033984 12I033994 12I034004 12I034214 12I034224 12I034234 12I034244 12I034254 12I034264 12I034274 12I034284 12I034304 12I034814 12I034824 12I034834 12I034844 12I034854 12I034864 12I034874 12I034884 12I034894 12I034924 12I034934 12I034944 12I034954 12I034964 12I034974 12I034984…
FDA’s list runs to 2,638 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 2,638 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
-
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.