Hobbs Medical Cytology Brush Recalled for Incorrect Expiration Date Labeling
Hobbs Medical is recalling Cytology Brush Catalog Number 4206 due to incorrect expiration dates on product labels that extend the intended shelf life. Approximately 300 units were distributed nationwide and internationally between March 2018 and September 2020.
What this means for you
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: This is an FDA Class II medical device recall with no reported illnesses or injuries. The hazard is a labeling error—incorrect expiration dates that extend the product's shelf life—a minor documentation issue with no reported harm, classified as Moderate per the rubric.
Plain-English summary
Hobbs Medical, Inc. is recalling its Cytology Brush Catalog Number 4206 because the device label displays an incorrect expiration date that extends the product's shelf life.
Approximately 300 units were distributed in the United States and internationally to Canada, Austria, Belgium, Finland, and Norway. The affected units have lot numbers ending in "R" or are kits containing at least one device with a lot number ending in "R." These units were distributed between March 25, 2018 and September 28, 2020.
Users and healthcare facilities with the affected device should discontinue use and contact Hobbs Medical, Inc. for guidance. Devices can be identified by the Unique Device Identifier (UDI-DI) M84942060 combined with the relevant lot numbers ending in "R."
The recalled product
- Product
- Hobbs Medical Cytology Brush Catalog Number: 4206
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Diagnostic
- Hazard
- expiration-mislabeling
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)
- UDI-DI:M84942060 Lot Numbers: H01-20-179R H01-20-181R H01-20-182R
Distribution
Distributed nationwide across the United States.
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