CooperSurgical Recalls MediCult Vitrification Cooling Media Due to Label Discrepancy
CooperSurgical is recalling 531 boxes of MediCult Vitrification Cooling Media because the Chinese text on the label incorrectly identifies the product as Equilibration Medium.
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 discrepancy without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
CooperSurgical, Inc. is recalling 531 boxes of MediCult Vitrification Cooling Media, Model Number 12284001F, Lot 20230080. The recall was initiated due to a discrepancy in the printing on the Product Tyvek label of the individual component packaging.
The Chinese characters on the label indicate that the product contains an Equilibration Medium (P/N: 12220001), whereas the remainder of the label correctly identifies it as Vitrification Medium (P/N: 12230001). The affected products were distributed to China.
This is a Class II recall. No specific instructions for consumers are provided in the source text, but the discrepancy involves product identification labeling.
The recalled product
- Product
- MediCult Vitrification Cooling Media, Model Number 12284001F
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 531
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 (1)
- Lot: 20230080
Distribution
Distribution scope not specified by the agency.
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