FDA Medical Device Recalls (openFDA)
MEDLINE INDUSTRIES, LP - Northfield: Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Recall number
- Z-1457-2025
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Status
- Open, Classified
- Initiated
- 2025-02-21
- Posted
- 2025-04-04
- Terminated
- not on file
- Reason
- 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.
- 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 recalls@medline.com.
- Quantity
- 468 units
- Distribution
- US: CA, FL, MN, NY, OH, OR, PA, TX, WV
- Lot, serial or model codes
- 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.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FDE
- Firm FEI
- 1417592
- Firm city
- Northfield
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28