Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K
Medical device recall Z-3037-2024. Published in FDA’s Enforcement Report on Sep 18, 2024.
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.
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Medline Convenience kits labeled as: 1) EP DRAPE PACK-LF, Pack Number DYNJ0209716K ; 2) MERCY COMBINED PACK-LF, Pack Number DYNJ0233004D ; 3) E P DRAPE PACK-LF , Pack Number DYNJ0373061J ; 4) PACEMAKER DRAPE PACK-LF , Pack Number DYNJ0406118K ; 5) FEMORAL ANGIOGRAPHY PACK, Pack Number DYNJ0618509F ; 6) EP DRAPE PACK-LF, Pack Number DYNJ22911I ; 7) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ36314J ; 8) SPLIT DRAPE , Pack Number DYNJ37265F ; 9) 4 DRAPE PROCEDURE PACK, Pack Number DYNJ39689D ; 10) DR MOTT DRAPE PACK, Pack Number DYNJ42065B ; 11) PK, EP LAB, Pack Number DYNJ43815C ; 12) MAYO STAND PACK , Pack Number DYNJ50738; 13) DAA BI-LAT, Pack Number DYNJ903538C; 14) PACEMAKER , Pack Number DYNJ903545C; 15) CSTM NEONATAL FEM DRAPE PK, Pack Number DYNJCD0114
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0209716K , Lot Number 19PBC426 ; DYNJ0233004D , Lot Number 19BKC696 ; DYNJ0233004D , Lot Number 19EKB353 ; DYNJ0233004D ,…
Every code shown here, 1,998 characters
DYNJ0209716K , Lot Number 19ABR348 ; DYNJ0209716K , Lot Number 19CBC954 ; DYNJ0209716K , Lot Number 19CBY010 ; DYNJ0209716K , Lot Number 19PBC426 ; DYNJ0233004D , Lot Number 19BKC696 ; DYNJ0233004D , Lot Number 19EKB353 ; DYNJ0233004D , Lot Number 19EKD788 ; DYNJ0233004D , Lot Number 19IKB771 ; DYNJ0233004D , Lot Number 19JKB511 ; DYNJ0233004D , Lot Number 20AKC285 ; DYNJ0233004D , Lot Number 20CKA142 ; DYNJ0233004D , Lot Number 20EKA118 ; DYNJ0233004D , Lot Number 20EKB817 ; DYNJ0233004D , Lot Number 20FKA173 ; DYNJ0233004D , Lot Number 20HKC130 ; DYNJ0233004D , Lot Number 20LKA046 ; DYNJ0373061J , Lot Number 21IBN110 ; DYNJ0373061J , Lot Number 21IBN112 ; DYNJ0373061J , Lot Number 21IBW039 ; DYNJ0373061J , Lot Number 21JBQ249 ; DYNJ0373061J , Lot Number 21JBQ254 ; DYNJ0373061J , Lot Number 22CBE209 ; DYNJ0373061J , Lot Number 22DBD601 ; DYNJ0373061J , Lot Number 22DBE605 ; DYNJ0373061J , Lot Number 22JBF498 ; DYNJ0373061J , Lot Number 22KBK232 ; DYNJ0373061J , Lot Number 22KBK234 ; DYNJ0373061J , Lot Number 23ABU873 ; DYNJ0373061J , Lot Number 23CBL581 ; DYNJ0373061J , Lot Number 23EBI151 ; DYNJ0373061J , Lot Number 23GBK887 ; DYNJ0373061J , Lot Number 23IBS102 ; DYNJ0373061J , Lot Number 23JBR178 ; DYNJ0373061J , Lot Number 23KBC777 ; DYNJ0373061J , Lot Number 23LBH622 ; DYNJ0373061J , Lot Number 24ABR895 ; DYNJ0373061J , Lot Number 21FBG073 ; DYNJ0373061J , Lot Number 19AKA894 ; DYNJ0373061J , Lot Number 19BKA317 ; DYNJ0373061J , Lot Number 19CKC943 ; DYNJ0373061J , Lot Number 19FKA631 ; DYNJ0373061J , Lot Number 19HKB486 ; DYNJ0373061J , Lot Number 19IKC235 ; DYNJ0373061J , Lot Number 19LKA527 ; DYNJ0373061J , Lot Number 20BKB137 ; DYNJ0373061J , Lot Number 20EKA922 ; DYNJ0373061J , Lot Number 20JKA379 ; DYNJ0373061J , Lot Number 20LKA412 ; DYNJ0406118K , Lot Number 19ABK827 ; DYNJ0406118K , Lot Number 19CBO755 ; DYNJ0406118K , Lot Number 19EBB219 ; DYNJ0406118K , Lot Number 19GBE862 ; DYNJ0406118K , Lot Number 19JBL458 ; DYNJ0618509F , Lot Number 19ABW463 ;…
FDA’s list runs to 5,318 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.
Worldwide distribution.
These words name no state.
The words say it went outside the United States too.
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.
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.
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.
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 5,318 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.