Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes
Medical device recall Z-2591-2026. 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. ANGIO PACK DYNJ30565C DYNJ32555B ANGIO PACK-LF DYNJ0774765U ANGIO TRAY DYNJ46153A ANGIOGRAM TRAY DYNJ33638K ANGIOGRAPHY DRAPE PK QVH-LF DYNJ35110D ANGIOGRAPHY PACK DYNJ44293D ANGIOGRAPHY PACK-LF DYNJ0854485T DYNJ35916J GENERAL ANGIO PACK DYNJ57760B GENERAL ENDO PACK-LF DYNJ0842873J JUDKINS PACK DYNJ51126A RADIOLOGY ANGIO MAJOR PACK DYNJ62858B TAVR JUDKINS PACK DYNJ51127B
113,843 kits, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281…
Every code shown here, 1,045 characters
DYNJ30565C UDI-DI 10889942165704 Lots 21CDA555 21DDA970 DYNJ32555B UDI-DI 10884389648216 Lot 21AMA053 DYNJ0774765U UDI-DI 10193489634594 Lot 21FLA468 DYNJ46153A UDI-DI 10889942185863 Lots 20XBH471 21BBC325 DYNJ33638K UDI-DI 10193489343281 Lot 21HLA726 DYNJ35110D UDI-DI 10193489329940 Lot 21IMC537 DYNJ44293D UDI-DI 10193489833416 Lots 21CBE250 21CBX084 21FBB546 21HBD075 21KBN509 22ABV463 22BBX022 22DBJ641 22HBB710 22HBT960 22IBD236 22OBF392 DYNJ0854485T UDI-DI 10193489864199 Lots 21FBC416 21GBL506 21IBO920 21JBS587 DYNJ35916J UDI-DI 10193489838404 Lots 21CBF463 21DBP668 21DBR247 DYNJ57760B UDI-DI 10193489342581 Lots 21CME104 21EME408 21FMD506 21GMG028 21JMF774 21KMH487 DYNJ0842873J UDI-DI 10193489448917 Lots 21ADA204 21CDB566 21EDB709 21GDC532 21HDC041 21JDB401 21JDC566 21LDA726 22BDA893 22CDC138 22EDA075 22FDC040 22HDB149 22JDA080 DYNJ51126A UDI-DI 10193489854886 Lots 21DDA694 21EDB249 21GDD164 21IDA472 21KDA815 DYNJ62858B UDI-DI 10193489891263 Lots 21FMF601 21HMF637 21HMG835 21JMF531 DYNJ51127B UDI-DI 10193489854893 Lot 22FBV791
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.”
- 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.