Medline Heart Basin Procedure Kits with Aortic Cannula Recalled
Medline medical procedure kits containing Medtronic Aortic Root Cannula are recalled due to potential excess material in the male luer connectors on the aortic cannula.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class I for a medical device (aortic cannula used in cardiac procedures), which per the rubric requires a minimum score of 4. No reported illnesses or injuries are stated in the source, but the potential for excess material in luer connectors on a critical cardiac device presents significant risk of harm.
Plain-English summary
Medline Industries is recalling 320 units of Heart Basin Pack-LF procedure kits that contain a Medtronic Aortic Root Cannula. The recall is due to the potential for excess material in the male luer connectors on the aortic cannula.
The affected kits were distributed in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. The recalled product is identified by UDI/DI 10195327563561 (each) and 40195327563562 (case), with lot numbers 24BMB798, 24DMH381, 24EMF949, 24GMF161, and 24IMB237.
Patients or healthcare facilities that have received this product should discontinue use and contact Medline Industries or their healthcare provider for instructions on return or replacement. The FDA has classified this recall as Class I.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: HEART BASIN PACK-LF
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 320
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- HEART BASIN PACK-LF
- UDI/DI 10195327563561 (ea) 40195327563562 (case)
- Lot Numbers 24BMB798
- 24DMH381
- 24EMF949
- 24GMF161
- 24IMB237.
Distribution
Part of a larger recall action
This product is one of 4 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield
See all →- CriticalIntubation trays recalled after laryngoscope handle lights failed to illuminate
FDA (Devices) · 2025-10-01
- SevereMedline Medical Convenience Kits with Defective Laryngoscope Handles
FDA (Devices) · 2025-10-01
- HighGood Neighbor alcohol prep pads recalled for alcohol below labeled concentration
FDA (Drugs) · 2025-09-03
- HighSurgical kits recalled because Foley tray inserts carry incorrect product information
FDA (Devices) · 2025-09-03
- HighSurgery trays recalled because they contain recalled tourniquet cuffs
FDA (Devices) · 2025-09-03
Same hazard · component defect
See all →- ModerateMedline EBSI dressing change kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline femoral block trays contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline breast hernia port kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
- ModerateCenturion dialysis and dressing change kits contain recalled Mastisol adhesive
FDA (Devices) · 2026-06-24
- ModerateMedline EBSI kits contain recalled Mastisol liquid adhesive
FDA (Devices) · 2026-06-24
Similar recalls
- ModerateMedline recalls cardiac surgery kits with non-conforming cannula components
FDA (Devices) · 2026-10-21
- HighMedline Recalls Surgical Kits With Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- SevereMedline Recalls Surgical Convenience Kits with Non-Conforming Cannula Components
FDA (Devices) · 2026-10-21
- HighMedline Medical Procedure Kits Recalled for Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30
- ModerateMedline Open Heart Kits Recalled Due to Incorrect Cannula Labeling
FDA (Devices) · 2024-10-23
- HighMedline Medical Procedure Kits Recalled Due to Potential Non-Sterility Risk
FDA (Devices) · 2024-10-30