Hobbs Medical Cytology Brush Recalled for Incorrect Expiration Dates
Hobbs Medical is recalling its Cytology Brush (catalog 4204) because device labels show incorrect expiration dates that extend the claimed shelf life. Affected devices were distributed in the US and several other countries from March 2018 to September 2020.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall with a labeling error affecting device expiration dates. This is a risk-of-harm product (cytology brush used in diagnostic procedures) where incorrect expiration dates could result in use of expired devices, but no illnesses or injuries have been reported.
Plain-English summary
Hobbs Medical, Inc. is recalling the Cytology Brush, Catalog Number 4204, due to incorrect expiration dates on device labels. The labels display expiration dates that extend beyond the actual shelf life of the devices.
Approximately 300 units were affected and distributed worldwide, including the United States, Canada, Austria, Belgium, Finland, and Norway. The US distribution occurred from March 25, 2018, through September 28, 2020. The recall involves devices with lot numbers ending in 'R' (H10-19-001R, H12-19-050R, and H12-19-051R) or kits containing at least one such device.
The incorrect expiration dates could allow devices to be used beyond their actual safe shelf life, potentially affecting device quality or performance. Users should verify expiration dates before using affected devices.
The recalled product
- Product
- Hobbs Medical Cytology Brush Catalog Number: 4204
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Cytology Brush
- Affected units
- 300
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: M84942040 Lot Numbers: H10-19-001R H12-19-050R H12-19-051R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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