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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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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Cardinal Health 200, LLC: Suction Canister Liners Recalled for Potential Loss of Suction

Agency Publication Date: January 18, 2024
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Summary

Cardinal Health is recalling approximately 3,783,489 Medi-Vac CRD Suction Canister Liners (1 Liter size) because they may lose suction during use. The issue is caused by the liner not aligning correctly with the outer hard canister, particularly when set to low or intermittent suction settings. If this happens during a medical procedure, it could prevent the removal of fluids, potentially delaying treatment. Consumers should check their inventory for the specific lot numbers and reference codes involved in this voluntary recall.

Risk

A misalignment between the liner and the canister can cause a complete or partial loss of suction. This failure could lead to an inability to remove surgical fluids or secretions, which may result in procedural delays or medical complications during patient care.

What You Should Do

  1. Locate the product packaging and check for the following reference numbers and case identifiers: REF 65651-510 (UDI/DI 50630140152649), REF 65651-516 (UDI/DI 50630140152633), or REF 65651-517 (UDI/DI 50630140152670).
  2. Check your specific lot numbers against the affected list. For REF 65651-510, affected lots include J308-602, J308-605, J308-609, J308-623, J308-624, J308-625, J308-628, J308-629, J308-630, J308-632, J308-633, J308-634, J308-635, J308-636, J308-637, J308-640, J308-642, J308-607, J308-643, J309-603, J309-607, J309-623, J309-627, J309-630, J309-632, J309-635, J309-636, J309-637, J310-601, J310-609, J310-621, J310-622, J310-626, J310-627, J310-641, J310-642, J310-643, and J310-644.
  3. For REF 65651-516, check for lot numbers: J308-606, J308-624, J308-628, J308-642, J308-643, J309-608, J309-610, J309-622, J309-626, J309-633, J309-645, J310-602, J310-617, and J310-645.
  4. For REF 65651-517, check for lot numbers: J308-625, J308-629, J308-637, J309-616, J309-634, J309-646, J309-647, J310-603, and J310-618.
  5. Immediately stop using the affected suction canister liners and sequester any remaining stock to prevent further use.
  6. Contact your healthcare provider or Cardinal Health directly to discuss next steps, disposal instructions, or potential replacements.
  7. For further questions or technical assistance, contact the FDA at 1-888-463-6332.

Your Remedy Options

๐Ÿ“‹Other Action

Healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: CardinalHealth Suction Canister Liner, MEDI-VAC CRD (1L)
Model / REF:
REF 65651-510
UPC Codes:
50630140152649
Lot Numbers:
J308-602
J308-605
J308-609
J308-623
J308-624
J308-625
J308-628
J308-629
J308-630
J308-632
J308-633
J308-634
J308-635
J308-636
J308-637
J308-640
J308-642
J308-607
J308-643
J309-603
J309-607
J309-623
J309-627
J309-630
J309-632
J309-635
J309-636
J309-637
J310-601
J310-609
J310-621
J310-622
J310-626
J310-627
J310-641
J310-642
J310-643
J310-644
Product: Cardinal Health MEDI-VAC CRD Suction Canister Liner, 1000 mL Kit with 5 mm 1.8 m Tube
Model / REF:
REF 65651-516
UPC Codes:
50630140152633
Lot Numbers:
J308-606
J308-624
J308-628
J308-642
J308-643
J309-608
J309-610
J309-622
J309-626
J309-633
J309-645
J310-602
J310-617
J310-645
Product: Cardinal Health Suction Canister Liner, MEDI-VAC CRD 1000 mL Kit with 6 mm 1.8 m Tube
Model / REF:
REF 65651-517
UPC Codes:
50630140152670
Lot Numbers:
J308-625
J308-629
J308-637
J309-616
J309-634
J309-646
J309-647
J310-603
J310-618

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93628
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Cardinal Health 200, LLC; Medical distributors; Hospitals
Manufactured In: United States
Units Affected: 3 products (3505730 units; 203244 units; 74515)
Distributed To: Nationwide

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.

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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.