Z-1457-2025Class I

Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK

Name: Z-1457-2025 Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2025-02-21
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-02-21 / Open, Classified

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK on 2025-02-21. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1457-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-02-21
Posted: 2025-04-04
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
Product code: FDE Laparoscopy Kit
Reason for recall: 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: Other
Action: 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].
Quantity in commerce: 468 units
Distribution: US: CA, FL, MN, NY, OH, OR, PA, TX, WV
Product codes and lots: TOL DR R PACK, UDI/DI 10195327166304 (ea) 40195327166305 (case), Lot Numbers 22GBL197, 22JBG283; TOL DR R PACK, UDI/DI 10195327273484 (ea) 40195327273485 (case), Lot Numbers 23ABO787, 23EBT153, 23HBB950; TOL DR R PACK, UDI/DI 10195327503390 (ea) 40195327503391 (case), Lot Numbers 24CBL126, 24EBV315, 24EBW136.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1457-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1456-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04
Z-1457-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04
Z-1458-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04
Z-1459-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-04-16	2025-04-04

Product code FDE

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)