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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

Medical Action Industries, Inc. 306: Foam Protective Pouches Recalled for Incorrect Labeling and Classification

Agency Publication Date: September 12, 2024
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Summary

Medical Action Industries, Inc. 306 is recalling approximately 5,981,534 Foam Protective Pouches across 13 different model numbers due to a labeling error. The pouches were improperly labeled with a Global Medical Device Nomenclature (GMDN) code that does not match their intended use, leading to potential misuse of the product. These blue foam pouches are sold in various quantities including individual pieces, cases, and rolls. Consumers should contact the manufacturer or their healthcare provider to ensure they are using the correct equipment for their medical needs.

Risk

The misclassification and incorrect labeling mean that these pouches could be used for medical purposes for which they were not intended or tested. This misuse can lead to ineffective protection of medical equipment or improper sterile barriers, potentially compromising patient safety during medical procedures.

What You Should Do

  1. Check your inventory for Foam Protective Pouches with the following model numbers and UDI-DI numbers: 6010 (20809160011253), 6010-1 (20809160011260), 6060 (20809160012090), 6070 (20809160011284), 6106 (20809160011314), 6141 (20809160011369), 6203 (20809160011741), 6805 (20809160011871), 6805-1 (20809160012069), 6810 (20809160012076), 6810-1 (20809160012083), 6830 (20809160012267), and 6860 (20809160012564).
  2. Verify if your product is part of 'All lots' currently affected by this recall notice.
  3. Identify the packaging type, which includes cases of 40 to 350 individual pouches or rolls containing 8 units per case.
  4. Contact Medical Action Industries, Inc. 306 or your healthcare provider for further instructions regarding the use of these pouches and to discuss potential replacements or refunds.
  5. For additional questions or to report issues, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Correction of labeling/classification

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

Affected Products

Product: Foam Protective Pouches (Model 6010)
Model / REF:
6010
20809160011253
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6010-1)
Model / REF:
6010-1
20809160011260
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6060)
Model / REF:
6060
20809160012090
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6070)
Model / REF:
6070
20809160011284
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6106)
Model / REF:
6106
20809160011314
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6141)
Model / REF:
6141
20809160011369
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6203)
Model / REF:
6203
20809160011741
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6805)
Model / REF:
6805
20809160011871
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6805-1)
Model / REF:
6805-1
20809160012069
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6810)
Model / REF:
6810
20809160012076
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6810-1)
Model / REF:
6810-1
20809160012083
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6830)
Model / REF:
6830
20809160012267
Lot Numbers:
All lots
Product: Foam Protective Pouches (Model 6860)
Model / REF:
6860
20809160012564
Lot Numbers:
All lots

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 95157
Status: Active
Manufacturer: Medical Action Industries, Inc. 306
Manufactured In: United States
Units Affected: 5,981,534 units
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.

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.