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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Medline Medical Procedure Kits Recalled for Aortic Root Cannula Defect

Agency Publication Date: April 4, 2025
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Summary

Medline Industries, LP is recalling 3,345 medical procedure kits that contain Medtronic Aortic Root Cannulae. These surgical convenience kits are used in various heart surgeries, including open-heart and bypass procedures. The recall was initiated because the connectors on the cannula may contain excess material that could block medical fluid flow or break off and enter a patient's bloodstream. No incidents or injuries have been reported to date. These kits were distributed to hospitals, surgical centers, and medical supply distributors in several states.

Risk

Excess material in the aortic root cannula's connector can cause surgical complications by restricting blood flow or introducing debris into the patient's circulatory system. This defect poses a critical risk of serious patient injury or death during cardiac surgery.

What You Should Do

  1. This recall affects Medline medical procedure kits containing Medtronic Aortic Root Cannulae, sold under kit names including CABG OPNHRT, CARDIAC PACK, HEART BASIN PACK, OPEN HEART, and TOL DR R PACK.
  2. Identify if you have affected kits by checking the product names, lot numbers, and Unique Device Identifier (UDI) codes on your inventory labels. Affected lot numbers include 23IBH906, 24EBC446, 22GMD767, 23IMA561, 24AMG704, and many others. See the Affected Products section below for the full list of affected codes.
  3. Stop using the recalled medical procedure kits immediately.
  4. Contact Medline Industries or your medical supply distributor to arrange for the return, replacement, or correction of any unused units.
  5. Call the FDA at 1-888-463-6332 (1-888-INFO-FDA) for additional information or questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Medline Medical Procedure Kits (containing Medtronic Aortic Root Cannula)
Variants: CABG OPNHRT S HSP, CARDIAC CABG, CARDIAC PACK, DR D AC PACK, HEART BASIN PACK-LF, K OH COMPONENT PACK, OPEN HEART ADULT PART 1 CDS, OPEN HEART B PACK-LF, OPEN HEART PACK, Z OPEN HEART
Lot Numbers:
23IBH906
24EBC446
24FMC989
24GME639
24KMB217
25AMG162
23LBV500
24DBS178
24EBK724
24FBL825
24CBN830
24DBS177
23HBD834
23IBF066
22GMD767
22JMD290
23GMC713
23IMA561
23KMC902
24EBT996
24IBR766
24KBJ595
24LBQ493
24CBG813
22IMH938
22KMC295
23AMD800
23DME198
23GMD603
23GMI093
23HMG457
23IMG457
23KMJ484
24AMG704
24AMI684
24BMG042
24GMA506
24GMA897
23JBD049
24EBT606
24IBE093
24JBV568
24KBR945
UDI:
10195327449650
40195327449651
10198459089503
40198459089504
10195327490362
40195327490363
10195327490355
40195327490356
10195327298258
40195327298259
10195327047573
40195327047574
10195327659684
40195327659685
10195327034726
40195327034727
10195327206383
40195327206384
10889942934164
40889942934165
10195327659882
40195327659883

Recall Number Z-1456-2025; Distributed Quantity: 1310 units.

Product: Medline Medical Procedure Kits (containing Medtronic Aortic Root Cannula)
Variants: TOL DR R PACK
Lot Numbers:
22GBL197
22JBG283
23ABO787
23EBT153
23HBB950
24CBL126
24EBV315
24EBW136
UDI:
10195327166304
40195327166305
10195327273484
40195327273485
10195327503390
40195327503391

Recall Number Z-1457-2025; Distributed Quantity: 468 units.

Product: Medline Medical Procedure Kits (containing Medtronic Aortic Root Cannula)
Variants: HEART BASIN PACK-LF
Lot Numbers:
24BMB798
24DMH381
24EMF949
24GMF161
24IMB237
UDI:
10195327563561
40195327563562

Recall Number Z-1458-2025; Distributed Quantity: 320 units.

Product: Medline Medical Procedure Kits (containing Medtronic Aortic Root Cannula)
Variants: CPB ADJUNCT PACK, DR. C PACK, PK CUST CV A&B C CO, TOL DR R PACK, TOL DR. C PACK, TOL DR. M PACK, TOL DR. CRESCENZO PACK
Lot Numbers:
24IBV027
22HBX339
22LBC389
23EBQ439
23HBG138
23KBS878
24CBB191
24EBD828
24FBO426
24HBP282
24JBL545
24LBR173
23KBC932
24CBP602
24EBV519
24GBI558
24GBX898
24IBE173
24IBE173A
25ABG352
UDI:
10198459054242
40198459054243
10195327176914
40195327176915
10195327273750
40195327273751
10195327513818
40195327513819
10198459054259
40198459054250
10195327513825
40195327513826
10198459054266
40198459054267

Recall Number Z-1459-2025; Distributed Quantity: 1247 units.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 96443
Status: Active
Manufacturer: MEDLINE INDUSTRIES, LP - Northfield
Sold By: Hospitals; Surgical Centers; Medical Supply Distributors
Manufactured In: United States
Units Affected: 4 products (1310 units; 468 units; 320 units; 1247 units)
Distributed To: California, Florida, Minnesota, New York, Ohio, Oregon, Pennsylvania, Texas, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.