Medical Action Industries Recalls Foam Protective Pouches Due to Labeling Error
Medical Action Industries is recalling foam protective pouches because they were improperly labeled with incorrect GMDN codes, leading to product misuse.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that led to misuse, but no specific injuries or illnesses are reported in the source text, fitting the criteria for moderate severity.
Plain-English summary
Medical Action Industries, Inc. is recalling Foam Protective Pouches, including model numbers 6010, 6010-1, 6060, 6070, 6106, 6141, 6203, 6805, 6805-1, 6810, 6810-1, 6830, and 6860. The recall involves 5,981,534 units that were distributed nationwide and to Canada.
The recall was initiated because the protective pouches were improperly labeled with Unique Device Identification (UDI) associated with an incorrect Global Medical Device Nomenclature (GMDN) code. This misclassification resulted in the blue foam pouches being misused.
No specific instructions for consumers are provided in the source text regarding immediate actions to take, but the recall is classified as Class II by the FDA.
The recalled product
- Product
- Foam Protective Pouches, model numbers 6010 (50 each/case), 6010-1 (350 each /case), 6060 (8 rolls/case), 6070 (75 each/case), 6106 (250 each/case), 6141 (250 each/case), 6203 (40 each/case), 6805 (50 each/case), 6805-1 (175 each/case), 6810 (50 each/case), 6810-1 (350…
- Manufacturer
- Medical Action Industries, Inc. 306
- Affected units
- 5,981,534
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 (13)
- Model Number (UDI-DI Number): 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)
- 6860 (20809160012564). All lots
Distribution
Distributed nationwide across the United States.
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