Integra Container Lids Recalled for Lack of FDA Clearance
Integra York PA, Inc. is recalling 84 container lids that were distributed without FDA clearance.
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, but the source text does not report any illnesses, injuries, or hospitalizations, and the hazard is related to regulatory clearance rather than a direct physical defect causing harm.
Plain-English summary
Integra York PA, Inc. is recalling 84 units of Integra Container Lids in various sizes and colors. The affected products include lids with catalogue numbers 730422, 730521, 730522, 730523, 730524, 730621, and 730622. These lids are intended for use in hospitals and healthcare facilities to contain medical devices that are steam sterilized.
The recall was initiated after an internal investigation identified that some of the colored lids were not yet cleared by the FDA for sale and were inadvertently distributed. The products were distributed in the United States to one repacker/relabeler, KLS Martin, and three medical facilities.
No specific instructions for consumers are provided in the source text, as the distribution was limited to specific medical facilities and a repacker. The FDA has classified this as a Class II recall.
The recalled product
- Product
- Integra Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Blue; Container Lid, ¿¿ Size, Red; Container Lid, ¿¿ Size, Gold; Container Lid, ¿¿ Size, Green; Container Lid, Full Size, Blue; Container Lid, Full Size, Red Catalogue Numbers: 730422, 730521, 730522, 730523, 730524…
- Manufacturer
- Integra York PA, Inc
- Affected units
- 84
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 (14)
- Container Lid
- ¿ Size
- Red
- Blue
- Gold
- Green
- Full Size
- Red Catalogue Numbers: 730422
- 730521
- 730522
- 730523
- 730524
- 730621
- 730622
Distribution
Distribution scope not specified by the agency.
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