Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY…
Medical device recall Z-1048-2020. Published in FDA’s Enforcement Report on Feb 12, 2020.
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 Feb 12, 2020. 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?
Incomplete seals on the sterile package may compromise the sterility
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Centurion-_General Surgery Trays DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 DYNDA1178 ICIO TRAY DYNDA1183 AUXILARY TOWEL PACK DYNDA1223 CUSTOM PREP CUP KIT DYNDA1223 CUSTOM PREP CUP KIT DYNDA1246A CIRCUMCISION PACK DYNDA1349A CIRCUMCISION TRAY DYNDA1388 STERILE EK DOUBLE PACK DYNDA1615 STERILE BARRIER KIT DYNDA1615 STERILE BARRIER KIT DYNDA1628 VAG DELIVERY ACCESSORY PACK DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1843A DISPOSABLE SUTURE TRAY FGS DYNDA1861 IR KIT DYNDA1904 PREP TRAY DYNDA2076 VEIN PROCEDURE KIT DYNDA2201 SMALL BOWL KIT DYNDA2241 CIRCUMCISION TRAY DYNDA2271 CIRCUMCISION TRAY DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER DYNDA2418 MINOR PROCEDURE TRAY DYNDA2498 STERILE UNIVERSAL 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
Lot Numbers: DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 2019031990 DYNDA1178 ICIO TRAY 2019050690 DYNDA1183 AUXILARY TOWEL PACK 2018100390 DYNDA1223 CUSTOM PREP CUP KIT 2019031290 DYNDA1223 CUSTOM PREP CUP KIT 2019021490 DYNDA1246A CIRCUMCISION…
Every code shown here, 1,024 characters
Lot Numbers: DYNDA1127A RADIOLOGY CUT DOWN TRAY #1 2019031990 DYNDA1178 ICIO TRAY 2019050690 DYNDA1183 AUXILARY TOWEL PACK 2018100390 DYNDA1223 CUSTOM PREP CUP KIT 2019031290 DYNDA1223 CUSTOM PREP CUP KIT 2019021490 DYNDA1246A CIRCUMCISION PACK 2018111290 DYNDA1349A CIRCUMCISION TRAY 2019030190 DYNDA1388 STERILE EK DOUBLE PACK 2019030890 DYNDA1615 STERILE BARRIER KIT 2019031590 DYNDA1615 STERILE BARRIER KIT 2019012390 DYNDA1628 VAG DELIVERY ACCESSORY PACK 2019040290 DYNDA1706A CIRCUMCISION TRAY W/OUT CLAMP 2019031290 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019061090 DYNDA1843A DISPOSABLE SUTURE TRAY FGS 2019030190 DYNDA1861 IR KIT 2019022590 DYNDA1904 PREP TRAY 2019011590 DYNDA2076 VEIN PROCEDURE KIT 2018101590 DYNDA2201 SMALL BOWL KIT 2019022690 DYNDA2241 CIRCUMCISION TRAY 2019032590 DYNDA2271 CIRCUMCISION TRAY 2019031990 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019050690 DYNDA2361 HYSTERO PACK - RADIOLOGY WEILER 2019030590 DYNDA2418 MINOR PROCEDURE TRAY 2019021390 DYNDA2498 STERILE UNIVERSAL KIT 2019061190
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.
Nationwide Foreign: GHANA
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 Dec 11, 2019.
- FDA classified it on Feb 5, 2020.
- FDA’s Enforcement Report published it on Feb 12, 2020.
- FDA terminated it on Sep 4, 2020.
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.