see RES for description
Medical device recall Z-2624-2024. Published in FDA’s Enforcement Report on Sep 4, 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 4, 2024. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Ongoing its status, in FDA’s file
- Not named no state, in where it went
- 1,679,067 units in total 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?
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?
see RES for description
1,679,067 units in total, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDS985445B , Lot Number19ABK040 ; CDS985445B , Lot Number19ABV498 ; CDS985445B , Lot Number19BBN825 ; CDS985445B , Lot Number19EBG359 ; CDS985445B , Lot Number19FBA393 ; CDS985445B , Lot Number19GBC446 ; CDS985445B , Lot Number19HBM036 ;…
Every code shown here, 1,994 characters
CDS985445B , Lot Number19ABK040 ; CDS985445B , Lot Number19ABV498 ; CDS985445B , Lot Number19BBN825 ; CDS985445B , Lot Number19EBG359 ; CDS985445B , Lot Number19FBA393 ; CDS985445B , Lot Number19GBC446 ; CDS985445B , Lot Number19HBM036 ; CDS985445B , Lot Number19JBS476 ; CDS985445B , Lot Number19LBC804 ; CDS985445B , Lot Number20BBA618 ; CDS985445B , Lot Number20CBI761 ; CDS985445B , Lot Number20DBM201 ; CDS985445B , Lot Number21ABX275 ; CDS985445B , Lot Number21CBG480 ; CDS985445B , Lot Number21CBV955 ; CDS985445B , Lot Number21DBQ516 ; CDS985445C , Lot Number21IBP827 ; CDS985445C , Lot Number21KBO008 ; CDS985445C , Lot Number22BBK102 ; CDS985445C , Lot Number22OBI304 ; CDS985445C , Lot Number22EBI120 ; CDS985445C , Lot Number22GBP605 ; CDS985445C , Lot Number22GBU597 ; CDS985445C , Lot Number22GBY036 ; CDS985445C , Lot Number22HMG268 ; CDS985445C , Lot Number22HMH893 ; CDS985445C , Lot Number22JME066 ; CDS985445C , Lot Number22KMC551 ; CDS985445C , Lot Number22LMA461 ; CDS985445C , Lot Number22LMC730 ; CDS985445C , Lot Number23AMG434 ; CDS985445C , Lot Number23FMC235 ; CDS985445C , Lot Number23GME307 ; CDS985445C , Lot Number23JMF730 ; DYNDA1233B , Lot Number21JBQ010 ; DYNDA2402A , Lot Number22JBE471 ; DYNDA2402A , Lot Number22JBH025 ; DYNDA2402A , Lot Number22KBU699 ; DYNDA2402A , Lot Number23ABN842 ; DYNDA2402A , Lot Number23CBM334 ; DYNDA2402A , Lot Number23EBS527 ; DYNDA2402A , Lot Number23HBL655 ; DYNDA2402A , Lot Number23HBZ380 ; DYNDA2402A , Lot Number23IBO904 ; DYNDA2402A , Lot Number23KBE880 ; DYNDA2795, Lot Number21HBS958 ; DYNDH1094, Lot Number22NBD305 ; DYNDH1094, Lot Number22DBE033 ; DYNDH1094, Lot Number20ABB780 ; DYNDH1094, Lot Number21DBO182 ; DYNDH1351B , Lot Number23IBK337 ; DYNDH1351B , Lot Number23IBP041 ; DYNDH1351B , Lot Number24ABU967 ; DYNDH1697, Lot Number22OBC291 ; DYNDH1697A , Lot Number22EBO835 ; DYNDH1697A , Lot Number22GBG348 ; DYNDH1697A , Lot Number22GBT117 ; DYNDH1697A , Lot Number22HBK868 ; DYNDH1697A , Lot Number22LBK070 ;…
FDA’s list runs to 568,010 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 Aug 28, 2024.
- FDA’s Enforcement Report published it on Sep 4, 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 568,010 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
-
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.