Hearth Record

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK…

Medical device recall Z-1884-2026. Published in FDA’s Enforcement Report on Apr 29, 2026.

FDA’s own record, on accessdata.fda.gov

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 Apr 29, 2026. 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.

Source:

What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.

What’s wrong with it?

Unapproved design changes to the products outside of the 510(k) clearance.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Which ones are recalled?

Medline Convenience Kits containing select SKUs of 10mL Polycarbonate Colored Syringes ANGIO KIT PACK DYNJ50783B ANGIO PHC DYNJ37485C C.I.C.N. ANGIO PACK DYNJ53064B FHT P NEURO PACK DYNJ39931D NEURO ARTERIOGRAM PACK-LF DYNJ0948060F NEURO KIT NAM0003 NEURO PACK DYNJ61542D NEURO RADIOLOGY PACK DYNJ59903B NEURO TRAY DYNJ84872A PK, CATH LAB-ANGIO DYNJ44027F QVH IR NEURO PACK DYNJ62176

270,311 total, in FDA’s words.

Source:

FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.

Codes to check against yours

DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840…

Every code shown here, 1,993 characters

DYNJ50783B UDI-DI 10193489227376 (EA) 40193489227377 (CS) LOT 23FBF183 DYNJ37485C UDI-DI 10193489760002 (EA) 40193489760003 (CS) LOTS 20BBX692 20DBC089 20EBG816 20FBR153 20HBN288 20IBK578 20KBW291 21BBB266 21CBW198 21FBH674 21GBS840 21GBS842 21JBU703 21LBX721 22BBV337 22EBN708 22IBJ467 22JBH996 22KBU901 22OBJ150 23ABG615 23BBF603 23CBC306 DYNJ53064B UDI-DI 10193489789164 (EA) 40193489789165 (CS) LOT 23HMI416 DYNJ39931D UDI-DI 10193489459364 (EA) 40193489459365 (CS) LOTS 23BBB182 23DBK363 24HBJ427 24JBI915 24JBV985 24KBH817 25GBI670 25IBS445 DYNJ0948060F UDI-DI 10889942825103 (EA) 40889942825104 (CS) LOTS 23FMA240 24EBR693 24GLB224 24HLA705 24JLA904 NAM0003 UDI-DI 10193489222555 (EA) 40193489222556 (CS) LOTS 20DBO375 20GBC317 20GBJ719 20HBC159 20HBD815 20HBF519 20IBA514 23CMC981 23DMC490 23DMF161 23GMA353 23HME057 23HMG264 23IMF173 23JMF878 23JMH829 23KME885 23LMA780 23LMD088 23LMG059 24AMF167 24AMH128 24EMG747 24HMJ041 24JMC680 DYNJ61542D UDI-DI 10195327507923 (EA) 40195327507924 (CS) LOT 24FMC929 DYNJ59903B UDI-DI 10195327131203 (EA) 40195327131204 (CS) LOTS 23EBQ216 23HBC089 23IBE176 23KBL439 23LBO494 24ABL938 24CBQ708 24EBB108 24FBA584 24FBN897 24JBC983 24JBO349 24KBB061 24KBT242 24LBP491 DYNJ84872A UDI-DI 10195327481506 (EA) 40195327481507 (CS) LOTS 23LBN462 24ABC179 DYNJ44027F UDI-DI 10193489783490 (EA) 40193489783491 (CS) LOTS 21FLA184 21FLA910 21ILA783 21JLA542 21LLA177 22ALA731 22BLA802 22DLA497 22ELA818 22FLA432 22GLB161 22HLB062 22JBC795 22JBM045 22KBO209 22KBO210 23DBR512 23FBQ563 23GBK955 23HBY707 23JBT738 23KBF311 23KBU563 24ABW467 24GBK560 24HBB843 24IBI798 24IBR643 24JBF292 DYNJ62176 UDI-DI 10193489631784 (EA) 40193489631785 (CS) LOTS 23ELA677 23GLA263 23KLB156 ***Updated 5/20/26 - The following lots were included in the customer letter but not the FDA submission.*** DYNJ0948060F lots 21AMA919 21AMB491 21BMC178 21HMF800 21JMG472 22AMB406 22CMI927 22EMC824 22GMF261 22IMA651 22JMG952 22KME549 22LMD531 23AMD745 23AMJ626 23CMB808 23DMC060 23EMB613…

FDA’s list runs to 3,025 characters. The first part is shown; the rest is on FDA’s record.

Source:

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 and the countries of Canada, Panama, Barbados.

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.

Source:

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.

Source:

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 Apr 17, 2026.
  • FDA’s Enforcement Report published it on Apr 29, 2026.
Source:

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.
Source:

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 3,025 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.
Source:

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.

Source:

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.

How to read a record

Four things every record does, shown on an example record made up for this guide.

An example record, made up for this guide

An example nursing home

Made up for this guide: no real place is shown

Not fully inspected in over two years (CMS flag)

11 health citations at the latest inspection cycle

The state average is 14.3.

Source:

CMS, State and US Averages and Health Deficiencies. Released Oct 28, 2026. Updated monthly.

From the homeNone yet. Replies and paid listings aren’t open, and when they open they will sit here, below the record.

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Every fact names its source.

Who published it, when, and how often it changes sit beside each fact, with a link to the agency’s own file.

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