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Lower risk Medical device recall · FDA · Published August 28, 2024

Medline CV I II Kits Recalled Due to Incorrect Labeling

Medline recalls CV I II kits with specific lot numbers due to incorrect labeling of model 30001 as 30000. Affected kits may have safety risks if used without proper identification.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-0123-2025Medical deviceMedline ›
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Recalling firmMEDLINE INDUSTRIES, LP - Northfield3 Lakes Dr · Northfield, IL 60093-2753
✎ GovInfoNow plain-language explainer

Medline is recalling certain CV I II kits that were incorrectly labeled as model 30000 instead of 30001 during manufacturing. This labeling error could lead to using the wrong model, which might cause safety issues if the kit is not properly identified. Read more at govinfonow.com/recall/54154-medline-cv-i-ii-kits-recalled-due-to-incorrect-labeling.

Source Summary by GovInfoNow · govinfonow.com/recall/54154-medline-cv-i-ii-kits-recalled-due-to-incorrect-labeling · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0123-2025

Cite this page

“Medline CV I II Kits Recalled Due to Incorrect Labeling.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/54154-medline-cv-i-ii-kits-recalled-due-to-incorrect-labeling. Based on FDA recall #Z-0123-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0123-2025%22&limit=1).

The FDA announced on 2024-08-28 that Medline Industries, LP is recalling MEDLINE KIT CV I II (REF DYNJ906071B) because certain kits contain incorrectly labeled Medtronic lots of DLP Vessel Cannulae. The company has identified the issue during manufacturing where model 30001 was mislabeled as model 30000.

How to tell if you have it

  • Brand: Medline
  • Product: MEDLINE KIT CV I II
  • Reference: DYNJ906071B
  • Lot Numbers: 24ABA223
  • UDI/DI (case): 40195327227235
  • UDI/DI (each): 10195327227234

The hazard

Medline Industries, LP identified that during manufacturing of three listed lot numbers, product for model 30001 was incorrectly labeled as model 30000. The kits contain recalled Medtronic lots of the DLP Vessel Cannulae.

Context

GovInfoNow's records show MEDLINE INDUSTRIES, LP - Northfield has 119 other recalls on record since 2021-10-22. Recent brand recalls include Medline medical kits with light failure in newborn resuscitation kits (2025-07-25), Foley Tray Kits with incorrect labeling risk (2025-07-23), and RepNewal Reprocessed St. Jude Catheters that may contain particulates (2025-07-14). Other recent recalls of similar products include Medline TRACH TUBE KIT Recall: Labeling Discrepancy Hazard (2026-07-10), Medline Convenience Kits Recall: Temperature Probes May Have Distribution Error (2026-05-28), and Medline Medical Procedure Kits: Catheter Issues Recalled (2026-05-04).

How to tell if you have this one

Check for lot number 24ABA223 on the kit. The kits are labeled with UDI/DI numbers 40195327227235 (case) and 10195327227234 (each).

  • Brand
    Medline
  • Category
    Medical device
FDA recall event · 6 products

All 6 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    US Nationwide distribution.
Recall numberProduct, codes & lotsQuantity
Z-0119-2025MEDLINE HEART CABG CDS, REF CDS983376R; UDI/DI 40195327548545 (case), 10195327548544 (each), Lot Numbers: 24BMF012, 24CMG49115 kits
Z-0120-2025MEDLINE HEART OVERHEAD TABLE PACK, REF DYNJ0778508J; UDI/DI 40195327563784 (case), 10195327563783 (each), Lot Numbers: 24BMD381, 24BMJ45260 kits
Z-0121-2025MEDLINE OPEN HEART PACK, REF DYNJ66216C; UDI/DI 40193489853361 (case), 10193489853360 (each), Lot Numbers: 23LBM368, 23LBH354123 kits
Z-0122-2025MEDLINE OPEN HEART, REF DYNJ904261B; UDI/DI 40193489479530 (case), 10193489479539 (each), Lot Numbers: 23LBR36430 units
Z-0123-2025MEDLINE KIT CV I II, REF DYNJ906071B; UDI/DI 40195327227235 (case), 10195327227234 (each), Lot Numbers: 24ABA22356 kits
Z-0124-2025MEDLINE OPEN HEART NIMC KIT, REF DYNJ908840; UDI/DI 40195327185078 (case), 10195327185077 (each), Lot Numbers: 24BMF23522 kits
Based on the official FDA remedy

What to do — step by step

  1. Check Kit Label

    Look for the lot number 24ABA223 on the kit's label to confirm if it is affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide distribution.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: Aug 28, 202412. FDA classified it Class II: Oct 17, 202423. Published in FDA’s Enforcement Report: Oct 23, 202432024
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-0123-2025 (August 28, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0123-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA