Hearth Record

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B

Medical device recall Z-3038-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.

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 Sep 18, 2024. 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?

Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

Source:

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

Which ones are recalled?

Medline Convenience kits labeled as: 1) ADMIT KIT , Pack Number DYKA1225B; 2) BRANSON SUPPLEMENTAL PACK , Pack Number DYNDA3019; 3) L & D PACK-LF , Pack Number DYNJ16121O ; 4) FAMILY PLANNING PACK, Pack Number DYNJ59783C ; 5) NEW LIFE PACK , Pack Number DYNJ69208A ; 6) NEW LIFE PACK , Pack Number DYNJ69208B ; 7) RADIOLOGY PACK, Pack Number DYNJ69603; 8)AMBULATORY MINI PACK, Pack Number DYNJ82579; 9) NURSING SKILLS, Pack Number EDUC1023

Source:

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

Codes to check against yours

DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ;…

Every code shown here, 1,333 characters

DYKA1225B, Lot Number 21GMC515 ; DYNDA3019, Lot Number 23BBO847 ; DYNDA3019, Lot Number 23GBI102 ; DYNDA3019, Lot Number 23HBO766 ; DYNJ16121O , Lot Number 23BBR366 ; DYNJ16121O , Lot Number 23DBR520 ; DYNJ16121O , Lot Number 23FBU745 ; DYNJ16121O , Lot Number 23GBV975 ; DYNJ16121O , Lot Number 23IBR246 ; DYNJ16121O , Lot Number 23LBR806 ; DYNJ16121O , Lot Number 24ABR196 ; DYNJ59783C , Lot Number 21KMF298 ; DYNJ59783C , Lot Number 23FMC164 ; DYNJ69208A , Lot Number 22KBV360 ; DYNJ69208A , Lot Number 23FBE076 ; DYNJ69208B , Lot Number 23IBN578 ; DYNJ69208B , Lot Number 23KBR836 ; DYNJ69603, Lot Number 21HMG219 ; DYNJ69603, Lot Number 21JMI295 ; DYNJ69603, Lot Number 22BMB206 ; DYNJ69603, Lot Number 22GMB031 ; DYNJ69603, Lot Number 22HMA445 ; DYNJ69603, Lot Number 22HMF745 ; DYNJ69603, Lot Number 22IME788 ; DYNJ69603, Lot Number 22JME874 ; DYNJ69603, Lot Number 23EMD691 ; DYNJ69603, Lot Number 23FMA290 ; DYNJ69603, Lot Number 23FMH511 ; DYNJ82579, Lot Number 23LBO804; DYNJ82579, Lot Number 23KBO218; DYNJ82579, Lot Number 23IBM199; DYNJ82579, Lot Number 23GBQ788; DYNJ82579, Lot Number 23EBT027; DYNJ82579, Lot Number 23EBC375; DYNJ82579, Lot Number 23CBP897; DYNJ82579, Lot Number 23BBG331; DYNJ82579, Lot Number 22LBH343; DYNJ82579, Lot Number 22HBQ045; EDUC1023 , Lot Number 22HDA683 ; EDUC1023 , Lot Number 22HDA854

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.

These words name no state.

The words say it went outside the United States too.

Source:

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

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 Apr 8, 2024.
  • FDA classified it on Sep 6, 2024.
  • FDA’s Enforcement Report published it on Sep 18, 2024.
Source:

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

Who is recalling it?

  • MEDLINE INDUSTRIES, LP - Northfield, of Northfield, IL.
  • Who began it, in FDA’s words: Voluntary: Firm initiated.
  • How the firm first told its customers: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
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.”
  • 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.

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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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