Medline Convenience kits labeled as: 1) FETOSCOPY CDS-LF, Pack Number CDS840215O
Medical device recall Z-3004-2024. 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) FETOSCOPY CDS-LF, Pack Number CDS840215O ; 2) BONE RETRIEVAL PART A , Pack Number CDS981237F ; 3) BASIC BIOPSY TRAY , Pack Number DYNDA1217A ; 4) ONCOLOGY PORT ACCESS TRAY , Pack Number DYNDC2239; 5) US BREAST BIOPSY TRAY, Pack Number DYNDH1187A; 6) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286A; 7) BONE MARROW TRAY - TUBE HLDR, Pack Number DYNDH1286AH; 8) PACK,BREAST BIOPSY, Pack Number DYNDL1498; 9) BONE MARROW PACK, Pack Number DYNJ0628436I ; 10) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035K; 11) SH STEREOTACTIC BIOPSY PK-LF, Pack Number DYNJ0660035KH; 12) OPP MINOR PACK-LF , Pack Number DYNJ0706869I ; 13) OPP MINOR PACK-LF , Pack Number DYNJ0706869IH; 14) BIOPSY DRAPE PACK , Pack Number DYNJ20953F ; 15) STEREOTACTIC TRAY , Pack Number DYNJ28856D ; 16) BIOPSY TRAY , Pack Number DYNJ31585C ; 17) BONE MARROW KIT PK, Pack Number DYNJ37526; 18) CT BIOPSY PACK-LF , Pack Number DYNJ38414B ; 19) CUSTOM BONE CEMENT TRAY-LF, Pack Number DYNJ42702D ; 20) LIVER TRANSPLANT PACK , Pack Number DYNJ43493A ; 21) BIOPSY TRAY , Pack Number DYNJ49368; 22) BONE MARROW HARVEST PACK, Pack Number DYNJ50740A ; 23) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550; 24) HINKAMP ACCESSORY PACK, Pack Number DYNJ66550A ; 25) NDN CUSTOM BONE RECOVERY, Pack Number DYNJ903942D; 26) MODULE BREAST BIOPSY, Pack Number DYNJ904158B; 27) PACK,FETOSCOPY, Pack Number DYNJ906905B; 28) MINOR/BREAST BIOPSY-LF, Pack Number DYNJS3035; 29) BREAST BIOPSY-LF, Pack Number DYNJT1911D ; 30) BIOPSY TRAY , Pack Number SPEC0150 ; 31) BIOPSY TRAY W/O LIDOCAINE , Pack Number SPEC0196B; 32) STEREOTACTIC BIOPSY TRAY, Pack Number SPEC0279
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O , Lot Number 22ABS124 ; CDS840215O , Lot Number 22EBA066 ; CDS840215O , Lot Number 22GBQ007 ; CDS840215O , Lot Number…
Every code shown here, 2,000 characters
CDS840215O , Lot Number 21HBJ135 ; CDS840215O , Lot Number 21JBS174 ; CDS840215O , Lot Number 22ABB090 ; CDS840215O , Lot Number 22ABS124 ; CDS840215O , Lot Number 22EBA066 ; CDS840215O , Lot Number 22GBQ007 ; CDS840215O , Lot Number 22GBQ009 ; CDS840215O , Lot Number 22HBU942 ; CDS840215O , Lot Number 23ABD369 ; CDS840215O , Lot Number 23CBO683 ; CDS840215O , Lot Number 23FBT988 ; CDS840215O , Lot Number 23GBI919 ; CDS840215O , Lot Number 23JBK910 ; CDS840215O , Lot Number 24ABE598 ; CDS840215O , Lot Number 20LBA006 ; CDS840215O , Lot Number 21ABQ774 ; CDS840215O , Lot Number 21ABR763 ; CDS840215O , Lot Number 21ABT392 ; CDS840215O , Lot Number 21CBM879 ; CDS840215O , Lot Number 21CBY329 ; CDS840215O , Lot Number 21DBP547 ; CDS981237F , Lot Number 19BBH974 ; CDS981237F , Lot Number 19DBZ760 ; CDS981237F , Lot Number 19GBG896 ; CDS981237F , Lot Number 19GBR697 ; CDS981237F , Lot Number 19IBK312 ; CDS981237F , Lot Number 19JBS472 ; CDS981237F , Lot Number 19VBE313 ; CDS981237F , Lot Number 19LBQ636 ; CDS981237F , Lot Number 20BBS514 ; DYNDA1217A , Lot Number 21JBQ356 ; DYNDC2239, Lot Number 21JBL152 ; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1187A, Lot Number 22HMH338; DYNDH1187A, Lot Number 22FMA363; DYNDH1187A, Lot Number 22EBC538; DYNDH1187A, Lot Number 22OBA249; DYNDH1187A, Lot Number 22BBZ459; DYNDH1286A, Lot Number 23FMA562; DYNDH1286A, Lot Number 23DME451; DYNDH1286A, Lot Number 23AMH934; DYNDH1286A , Lot Number 23JMC410 ; DYNDH1286AH, Lot Number 23FMA562; DYNDH1286AH, Lot Number 23DME451; DYNDH1286AH, Lot Number 23AMH934; DYNDH1286AH, Lot Number 23JMC410 ; DYNDL1498, Lot Number 21JBM328 ; DYNJ0628436I , Lot Number 20CDA324 ; DYNJ0628436I , Lot Number 20DDB806 ; DYNJ0628436I , Lot Number 20FDA658 ; DYNJ0628436I , Lot Number 20IDB329 ; DYNJ0628436I , Lot Number 20LDC229 ; DYNJ0628436I , Lot Number 21ADA277 ; DYNJ0628436I , Lot Number…
FDA’s list runs to 15,474 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 15,474 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.