Medline Convenience kits labeled as: 1) GB GENERAL ENDO , Pack Number CDS984155G
Medical device recall Z-3012-2024. 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) GB GENERAL ENDO , Pack Number CDS984155G ; 2) BAPTIST FLOYD ENDO GI KIT , Pack Number DYKE1455B; 3) ENDO KIT, Pack Number DYKE1487C; 4) BRONCH ENDO W/O BEDSIDE KIT , Pack Number DYKE1634 ; 5) ENDO KIT, Pack Number DYKE1696 ; 6) PULMONARY ENDO KIT, Pack Number DYKE1713 ; 7) ENDO KIT, Pack Number DYKE1739 ; 8) ENDOSCOPY PACK-LF , Pack Number DYNJ00339K ; 9) GENERAL ENDOSCOPIC PACK-LF, Pack Number DYNJ0190667K ; 10) CH UMBIL CATH W/INSTR PACK-LF, Pack Number DYNJ0622040Q; 11) ENDOSCOPY-LF, Pack Number DYNJ22890M ; 12) ENDOSCOPIC PACK , Pack Number DYNJ30434I ; 13) ENDOSCOPIC SINUS PACK , Pack Number DYNJ40644A ; 14) ENDOSCOPY PACK, Pack Number DYNJ40645B; 15) ENDO SURGICAL PACK WRO-LF , Pack Number DYNJ41870B ; 16) ENT PK 1008847, Pack Number DYNJ42319C ; 17) ENDOVENOUS BASIC PACK , Pack Number DYNJ42456D ; 18) UROLOGY ENDOSCOPE PACK 319738 , Pack Number DYNJ44638C ; 19) ENDOSCOPY PACK-LF , Pack Number DYNJ53271C ; 20) ENDOSCOPY , Pack Number DYNJ62133; 21) ENDOSCOPY PACK, Pack Number DYNJ62193; 22) ENDOVENOUS CORE PACK, Pack Number DYNJ62557; 23) ENDOSCOPY PACK, Pack Number DYNJ62914; 24) ENDOSCOPIC PACK , Pack Number DYNJ63797A ; 25) ENDOVENOUS ABLATION PACK, Pack Number DYNJ64059; 26) GENERAL ENDOSCOPY PACK, Pack Number DYNJ65371; 27) GYN ENDOSCOPY PACK, Pack Number DYNJ65372; 28) CV NEONATAL PACK, Pack Number DYNJ67356; 29) PEDI ENDO LAP PACK, Pack Number DYNJ68141A ; 30) ENSEMBLE CATHETER DIALYSE-LF, Pack Number DYNJ81973; 31) ENT , Pack Number DYNJ900282I; 32) MUH ENDOCRINE , Pack Number DYNJ901706J; 33) SEPTO/ENDO, Pack Number DYNJ902831D; 34) MODULE ENDO LAP , Pack Number DYNJ903026I; 35) CVOR ENDOSTENT, Pack Number DYNJ906465 ; 36) ENDOSCOPIC SKULL BASE , Pack Number DYNJ906630 ; 37) ENDO CHOLE TRAY , Pack Number LZ7759N; 38) CATHETERIZATION TRAY, Pack Number UVT1175; 39) UMBILICAL VESSEL INSERTION TRA, Pack Number UVT730; 40) TVS4000 ENDOVENOUS PACK, Pack Number TVS4000K
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDS984155G , Lot Number 21GBT672 ; CDS984155G , Lot Number 21JBH429 ; CDS984155G , Lot Number 21LBP590 ; CDS984155G , Lot Number 22CBJ567 ; CDS984155G , Lot Number 22FBB170 ; CDS984155G , Lot Number 22GBB172 ; CDS984155G , Lot Number…
Every code shown here, 1,998 characters
CDS984155G , Lot Number 21GBT672 ; CDS984155G , Lot Number 21JBH429 ; CDS984155G , Lot Number 21LBP590 ; CDS984155G , Lot Number 22CBJ567 ; CDS984155G , Lot Number 22FBB170 ; CDS984155G , Lot Number 22GBB172 ; CDS984155G , Lot Number 22GBW487 ; CDS984155G , Lot Number 22HBN079 ; CDS984155G , Lot Number 22IBR934 ; CDS984155G , Lot Number 19LBO258 ; CDS984155G , Lot Number 20BBE301 ; CDS984155G , Lot Number 20EBC706 ; CDS984155G , Lot Number 20EBS188 ; CDS984155G , Lot Number 20GBA894 ; CDS984155G , Lot Number 20IBD347 ; CDS984155G , Lot Number 20JBK812 ; CDS984155G , Lot Number 21BBO717 ; CDS984155G , Lot Number 21EBO578 ; DYKE1455B, Lot Number 20GBI602 ; DYKE1487C, Lot Number 22GMD695 ; DYKE1634 , Lot Number 19DAA540 ; DYKE1634 , Lot Number 19DAB449 ; DYKE1634 , Lot Number 19JAA076 ; DYKE1634 , Lot Number 21LBY138 ; DYKE1634 , Lot Number 22ABW321 ; DYKE1634 , Lot Number 22IBN133 ; DYKE1634 , Lot Number 23ABN492 ; DYKE1634 , Lot Number 23EBE760 ; DYKE1634 , Lot Number 20BBY787 ; DYKE1634 , Lot Number 23FBP558 ; DYKE1634 , Lot Number 20EBI139 ; DYKE1634 , Lot Number 23KBU935 ; DYKE1634 , Lot Number 20HBM035 ; DYKE1634 , Lot Number 20IBS530 ; DYKE1634 , Lot Number 20JBF837 ; DYKE1696 , Lot Number 23LMF046 ; DYKE1713 , Lot Number 22ABU757 ; DYKE1713 , Lot Number 22BBY210 ; DYKE1713 , Lot Number 22GBJ615 ; DYKE1713 , Lot Number 22KBC587 ; DYKE1713 , Lot Number 19JBJ509 ; DYKE1713 , Lot Number 23BBL166 ; DYKE1713 , Lot Number 23BBU192 ; DYKE1713 , Lot Number 23EBA547 ; DYKE1713 , Lot Number 20BBA308 ; DYKE1713 , Lot Number 23FBT851 ; DYKE1713 , Lot Number 20CBW284 ; DYKE1713 , Lot Number 20DBU069 ; DYKE1713 , Lot Number 23JBY319 ; DYKE1713 , Lot Number 23KBI749 ; DYKE1713 , Lot Number 20IBD604 ; DYKE1713 , Lot Number 20IBD920 ; DYKE1713 , Lot Number 21BBR876 ; DYKE1713 , Lot Number 21CBZ238 ; DYKE1713 , Lot Number 21EBI062 ; DYKE1713 , Lot Number 21EBI179 ; DYKE1739 , Lot Number 21FBI996 ; DYKE1739 , Lot Number 20ABX716 ; DYKE1739 , Lot Number 20DBC649 ; DYKE1739 , Lot…
FDA’s list runs to 20,243 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 20,243 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.