See RES description
Medical device recall Z-2628-2024. 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 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
00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ, Lot Number 23FBJ579 ; 00-398650AJ, Lot Number 23FBT136 ; 00-398650AJ, Lot Number 23IBB919 ; 00-398650AJ, Lot Number…
Every code shown here, 1,995 characters
00-398650AJ, Lot Number 23ABN193 ; 00-398650AJ, Lot Number 23ABN291 ; 00-398650AJ, Lot Number 23EBQ823 ; 00-398650AJ, Lot Number 23FBJ579 ; 00-398650AJ, Lot Number 23FBT136 ; 00-398650AJ, Lot Number 23IBB919 ; 00-398650AJ, Lot Number 23KBE097 ; 00-398650AJ, Lot Number 23LBS258 ; 00-398725AL, Lot Number 19BBA371 ; 00-398725AL, Lot Number 19CBE645 ; 00-398725AL, Lot Number 19DBR240 ; 00-398725AL, Lot Number 19EBK403 ; 00-398725AL, Lot Number 19FBU700 ; 00-398725AL, Lot Number 19GBR148 ; 00-398725AN, Lot Number 21FBS869 ; 00-398725AN, Lot Number 21JBN432 ; 00-398725AN, Lot Number 21LBK643 ; 00-398725AN, Lot Number 22ABX426 ; 00-398725AN, Lot Number 22BBR469 ; 00-398725AN, Lot Number 22CBU793 ; 00-398725AN, Lot Number 22OBM117 ; 00-398725AN, Lot Number 22EBK111 ; 00-398725AN, Lot Number 22GBJ289 ; 00-398725AN, Lot Number 22IBU378 ; 00-398725AN, Lot Number 22JBV752 ; 00-398725AN, Lot Number 22LBE100 ; 00-398725AN, Lot Number 23ABO369 ; 00-398725AN, Lot Number 23BBT199 ; 00-398725AN, Lot Number 23DBI838 ; 00-398725AN, Lot Number 23EBN543 ; 00-398725AN, Lot Number 23FBJ242 ; 00-398725AN, Lot Number 23HBB887 ; 00-398725AN, Lot Number 23IBG737 ; 00-398725AN, Lot Number 23JBD877 ; 00-398725AN, Lot Number 23KBT703 ; 00-398725AN, Lot Number 23LMC442 ; 00-399024AA, Lot Number 21GBA375 ; 00-399024AA, Lot Number 21HBS579 ; 00-399024AA, Lot Number 21VBC664 ; 00-399024AB, Lot Number 22ABB635 ; 00-399024AB, Lot Number 22BBO663 ; 00-399024AB, Lot Number 22EBG768 ; 00-399024AB, Lot Number 22IBI311 ; 00-399024AB, Lot Number 22JBH694 ; 00-399024AB, Lot Number 22KBU955 ; 00-399024AB, Lot Number 23FBJ294 ; 00-399024AB, Lot Number 23FBJ440 ; 00-399024AB, Lot Number 23KMC721 ; 00-399024Y , Lot Number 20EBH037 ; 00-399024Y , Lot Number 20FBK078 ; 00-399024Y , Lot Number 20GBR534 ; 00-399024Y , Lot Number 21ABP810 ; 00-399024Y , Lot Number 21CBU873 ; 00-399024Y , Lot Number 21EBP778 ; 00-400065L , Lot Number 23DBD207 ; 00-400065L , Lot Number 23EBJ498 ; 00-400065L , Lot Number 23GBJ037 ;…
FDA’s list runs to 1,232,234 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 1,232,234 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.