INCISION & DRAINAGE TRAY or KIT
Medical device recall Z-1088-2018. Published in FDA’s Enforcement Report on Mar 28, 2018.
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 Mar 28, 2018. Copied from openFDA on Oct 20, 2026.
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?
Convenience Kit contains a PVP Prep Pad, received by a supplier, that does not meet the iodine assay level required to support the 36 month shelf life.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
INCISION & DRAINAGE TRAY or KIT
How much: “N/A”, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
ID1090 ID1485 ID1525 ID1595 ID510 ID525 ID580 ID600 ID800 ID875 ID975 Lot codes: 2015102190 2016010790 2016020890 2016022390 2016061090 2016071990 2016101290 2016110390 2017011990 2016121690 2017022390 2017052690 2015101490 2016060690…
Every code shown here, 1,312 characters
ID1090 ID1485 ID1525 ID1595 ID510 ID525 ID580 ID600 ID800 ID875 ID975 Lot codes: 2015102190 2016010790 2016020890 2016022390 2016061090 2016071990 2016101290 2016110390 2017011990 2016121690 2017022390 2017052690 2015101490 2016060690 2016070890 2016102490 2017032190 2017052390 2015091790 2015111990 2015112590 2016070890 2016072790 2016082390 2017020290 2017032890 2017052690 2017030390 2015092490 2015121490 2016010690 2016033190 2016042790 2016052490 2016061390 2016102790 2016112490 2017042890 2017063090 2017071990 2015100890 2017072890 2017040690 2016092290 2016031790 2016012190 2017030290 2016021890 2016060890 2016070790 2016080590 2016111190 2017010990 2017051190 2015110590 2015103090 2016071490 2015121590 2016031590 2016042090 2016051890 2016052590 2016062190 2016110190 2017010390 2017020890 2017040490 2017060890 2017062890 2017082290 2016112290 2016042790 2017060890 2017070790 2017082490 2015101590 2016022590 2016072890 2016090290 2017011190 2017040690 2017061690 2017081190 2017011690 2015092490 2015100890 2015111990 2016040690 2016060890 2016071890 2017013090 2016030790 2016031590 2016080190 2017010390 2017050490 2016072090 2015081190 2015102790 2016010490 2016022490 2016031190 2016060690 2016082990 2016111790 2017011790 2017032890 2017060790 2017071290 2016011590 2016062390 2016062890
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.
Nationally
These words name no state.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
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 Oct 23, 2017.
- FDA classified it on Mar 17, 2018.
- FDA’s Enforcement Report published it on Mar 28, 2018.
- FDA terminated it on Jun 21, 2018.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Centurion Medical Products Corporation, of Williamston, MI.
- 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.”
- 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.