Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medical device recall Z-2585-2026. Published in FDA’s Enforcement Report on Jul 1, 2026.
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 Jul 1, 2026. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Nationwide FDA’s word, and 34 states named
- 113,843 kits 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?
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. AAA DYNJ905651B ARTERIOGRAM TRAY 00-402001S AV SHUNT PACK-LF DYNJ0842516F BASIC IR PACK-LF PHS463660F CATH PROCEDURAL TRAY DYNJ43580C CONGENITAL ADD-ON KIT DYNDA2213A CUSTOM PROCEDURE KIT DYNJ65277A DEEP BRAIN STIMULATION PACK DYNJ0842793F HOSPITAL REGIONAL DE CONCEPCIO DYNJ67918 INTERVENTIONAL PACK DYNJ56666B INVASIVE LINE INSERTION DYNJ44123A JUDKINS PACK DYNJ51126B LARKIN CUSTOM NEURO TRAY PAIN1454 MAJOR PLUS PACK DYNJ905160I MINIMALLY INVASIVE PACK-LF DYNJ0843063J NEURO ANGIO PACK SJF-LF DYNJ37304F NON-VASCULAR PACK DYNJ56386B OR HYBRID-MRMC DYNJ907758 PACER PACK DYNJ40952 PAIN PACK DYNJ60715 PICC PHC DYNJ37484B ROBOTIC PACK DYNJ908706A THORACOTOMY PACK-LF DYNJ0101339J DYNJ69090 VENOUS PACK DYNJ56260B
113,843 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353…
Every code shown here, 1,986 characters
DYNJ905651B UDI-DI 10193489925067 Lot 24BME750 00-402001S UDI-DI 10889942893645 Lots 21ABV063 21BBK296 21OBA437 DYNJ0842516F UDI-DI 10193489352375 Lots 21BDB242 21CDC063 21HDB970 21IDB395 21KDC355 22BDA157 22DDB628 22FDA331 22GDB353 PHS463660F UDI-DI 10195327096991 Lots 22BBT652 22DBK236 DYNJ43580C UDI-DI 10889942249398 Lots 21BDB710 21DDB799 DYNDA2213A UDI-DI 10889942925421 Lots 23LBC294 DYNJ65277A UDI-DI 10193489409536 Lots 24BBD609 24BBD609A DYNJ0842793F UDI-DI 10193489345230 Lots 21CDA191 21CDC092 21EDA769 21GDB289 21HDC822 22BDB295 22DDA792 22EDB725 22IDC164 DYNJ67918 UDI-DI 10193489459081 Lots 21ABP630 21DBL459 21EBD905 21HBE280 21HBE285 21IBS959 21VBD188 DYNJ56666B UDI-DI 10888277740273 Lots 21BMB700 21CMA789 DYNJ44123A UDI-DI 10889942952977 Lots 21ABV982 21CBB916 21HBQ740 21KBE936 21VBC816 22ABS461 22CBX354 22DBD608 22EBT322 22GBR526 22HBS119 22LBA937 22LBM278 23ABJ758 23BBG292 23CBD680 DYNJ51126B UDI-DI 10195327044138 Lots 22ADA961 22BDC241 22DDA320 22DDB652 22FBD047 22FBH293 22HBQ223 22HBY535 22JBG518 PAIN1454 UDI-DI 10193489688863 Lots 21CBA985 21DBU969 21FBN495 21GBG636 21KBJ919 22ABJ583 22BBN243 22IBT753 22KBA570 23ABK226 23IBE552 23JBF419 23KBJ152 DYNJ905160I UDI-DI 10193489397482 Lots 21BBE987 21DBD058 21EBC916 DYNJ0843063J UDI-DI 10193489345377 Lots 21CDA233 21EDC220 21GDC682 21IDA570 21JDA064 21LDA151 22ADC136 22CDB166 22EDA616 22FDB836 22HDB150 22KDA481 DYNJ37304F UDI-DI 10889942727919 Lot 23KMI510 DYNJ56386B UDI-DI 10888277762886 Lots 21CBX170 21GBQ837 21JBW253 21LBH797 22ABX259 22BBC246 22CBW026 22DBU970 22GBA195 22HBL094 22LBH829 23ABG503 23ABO274 23BBO056 23DBQ675 23FBQ670 23HBV115 23JBC749 23JBP144 DYNJ907758 UDI-DI 10193489872002 Lot 21FBF623 DYNJ40952 UDI-DI 10884389898826 Lot 21FBK360 DYNJ60715 UDI-DI 10193489520279 Lot 24ABO126 DYNJ37484B UDI-DI 10889942777792 Lots 21BDA459 21DDA549 21DDB648 21GDC975 21IDB972 21JDC475 21LDB205 22ADC256 22BDB581 22FDA100 22GDB220 22IDB953 22KDB836 23ADA661 23CDB420 23DDC200 DYNJ908706A UDI-DI…
FDA’s list runs to 2,273 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.
US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IL, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NE, NJ, NM, NV, NY, OH, OK, OR, PA, RI, TN, TX, VA, WI, WY and the country of Barbados.
The states and territories these words name
34 states and territories.
Every one of them
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Florida
- Georgia
- Illinois
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- Nebraska
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- Tennessee
- Texas
- Virginia
- Wisconsin
- Wyoming
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?
Ongoing, in FDA’s file.
“A recall which is currently in progress.”
openFDA, on “On-Going”, 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 Feb 27, 2026.
- FDA classified it on Jun 25, 2026.
- FDA’s Enforcement Report published it on Jul 1, 2026.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Medline Industries, LP, of Northfield, IL.
- 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 2,273 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.