Medline medical procedure kits recalled for defective aortic cannula connectors
Medline is recalling 468 medical procedure kits containing Medtronic Aortic Root Cannulas due to excess material in the male connectors that could affect proper assembly during cardiac procedures.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall involving a manufacturing defect in a critical cardiac surgical component. The recall criteria mandate that FDA Class I recalls should never score below 4. Although no illnesses or deaths have been reported, the potential for serious harm during aortic root cannulation procedures justifies the Severe classification.
Plain-English summary
Medline Industries is recalling 468 medical procedure kits containing Medtronic Aortic Root Cannulas (marketed as TOL DR R PACK) due to a manufacturing defect. The cannulas contain excess material in the male lures (connectors), which could cause improper connections during surgical assembly.
The affected kits were distributed to healthcare facilities in California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, and West Virginia. Affected lot numbers include: 22GBL197, 22JBG283, 23ABO787, 23EBT153, 23HBB950, 24CBL126, 24EBV315, and 24EBW136.
Healthcare providers who have received these kits should stop using them immediately and contact Medline Industries for replacement units.
The recalled product
- Product
- Medline medical procedure kits, containing Medtronic Aortic Root Cannula, labeled as follows: TOL DR R PACK
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- manufacturing-defect
- connector-defect
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 (12)
- TOL DR R PACK
- UDI/DI 10195327166304 (ea) 40195327166305 (case)
- Lot Numbers 22GBL197
- 22JBG283
- UDI/DI 10195327273484 (ea) 40195327273485 (case)
- Lot Numbers 23ABO787
- 23EBT153
- 23HBB950
- UDI/DI 10195327503390 (ea) 40195327503391 (case)
- Lot Numbers 24CBL126
- 24EBV315
- 24EBW136.
Distribution
Distributed in 9 states:
- CA
- FL
- MN
- NY
- OH
- OR
- PA
- TX
- WV
Related recalls
Same category
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03
- SevereAbiomed Automated Impella Controller recalled for motor control and pump failure risks
FDA (Devices) · 2026-06-03
- HighGE APEXPRO and CARESCAPE Telemetry Systems Risk Loss of Patient Monitoring
FDA (Devices) · 2026-06-03
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03