Medline medical procedure kits, containing Medtronic Aortic… recallZ-1458-2025 · MEDLINE INDUSTRIES, LP - Northfield · initiated Feb 21, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the potential excess material in the male lures on the aortic cannula.
FDA root cause category: Other
What the company is doing
Medline issued a MEDTRONIC MEDICAL DEVICE RECALL NOTICE to its consignees on 02/21/2025 via email. The notice explained the issue and potential risk. Upon receipt of the completed recall response form, over-labels will be provided, which are to be placed on kits that contain the recalled component and will state the affected component shall be removed and discarded from further use. Distributors, or those who have resold or transferred this product to another company or individual were directed to notify their customers. For questions, contact the Recall Department at 866-359-1704 or [email protected].
Recall details
- Recall number
- Z-1458-2025
- Status
- Open, Classified
- Initiated by the company
- Feb 21, 2025
- Posted by the FDA
- Apr 4, 2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 320 units
- Product code
- KDD
- Distribution
- US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Product description
Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
Code information (models, lots, serial numbers)
HEART BASIN PACK-LF, UDI/DI 10195327563561 (ea) 40195327563562 (case), Lot Numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, 24IMB237.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Medline Industries, Inc. DYNJ0778497FMedline Industries, Inc. · Kit, surgical instrument, disposable1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 96443).
- Z-1456-2025 · Open, ClassifiedMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K …
- Z-1457-2025 · Open, ClassifiedMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Z-1459-2025 · Open, ClassifiedMedline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TO…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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