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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Medline Surgical Kits Recalled for Mislabeled Vessel Cannulae

Agency Publication Date: October 17, 2024
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Summary

Medline Industries, LP is recalling approximately 306 surgical kits because they contain mislabeled vessel cannulae (medical tubes used in heart surgery). During manufacturing, Medtronic DLP Vessel Cannulae model 30001 were incorrectly labeled as model 30000. This error affects various kits used in open heart surgery and coronary artery bypass graft procedures.

Risk

A mislabeled cannula could lead to the wrong size or type of medical device being used during a surgical procedure, potentially impacting patient safety or procedural success. No injuries or incidents have been reported to date.

What You Should Do

  1. This recall affects various Medline surgical kits including Heart CABG CDS, Heart Overhead Table Packs, Open Heart Packs, Kit CV I II, and Open Heart NIMC Kits.
  2. Check the model numbers (REF) and lot numbers on your kit labels to determine if your product is affected. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled surgical kits immediately. Contact Medline Industries, LP or your distributor to arrange for the return, replacement, or correction of the kits.
  4. For additional information, contact Medline Industries directly.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls for more information.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: MEDLINE HEART CABG CDS
Model / REF:
CDS983376R
Lot Numbers:
24BMF012
24CMG491
UDI:
40195327548545
10195327548544

Quantity: 15 kits

Product: MEDLINE HEART OVERHEAD TABLE PACK
Model / REF:
DYNJ0778508J
Lot Numbers:
24BMD381
24BMJ452
UDI:
40195327563784
10195327563783

Quantity: 60 kits

Product: MEDLINE OPEN HEART PACK
Model / REF:
DYNJ66216C
Lot Numbers:
23LBM368
23LBH354
UDI:
40193489853361
10193489853360

Quantity: 123 kits

Product: MEDLINE OPEN HEART
Model / REF:
DYNJ904261B
Lot Numbers:
23LBR364
UDI:
40193489479530
10193489479539

Quantity: 30 units

Product: MEDLINE KIT CV I II
Model / REF:
DYNJ906071B
Lot Numbers:
24ABA223
UDI:
40195327227235
10195327227234

Quantity: 56 kits

Product: MEDLINE OPEN HEART NIMC KIT
Model / REF:
DYNJ908840
Lot Numbers:
24BMF235
UDI:
40195327185078
10195327185077

Quantity: 22 kits

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95393
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Surgical Centers; Medical Distributors
Manufactured In: United States
Units Affected: 6 products (15 kits; 60 kits; 123 kits; 30 units; 56 kits; 22 kits)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.