Affirm® Prone Breast Biopsy System
Affirm® Prone Breast Biopsy System Recall The Affirm® Prone Breast Biopsy System is being recalled across Canada due to a performance issue with the device. This device is used to perform breast biopsies. The recall is classified as Class I, which indicates a serious concern with how the product functions.
- Product
- Affirm® Prone Breast Biopsy System
- Reason
- Performance
- Classification
- Class I
- Category
- drug recall
- Country
- Canada
- Agency
- HC-DEVICES
- Recall date
- 2025-07-30
- Status
- Ongoing
- Distribution
- Canada-wide
Official recall notice from HC-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/cad85ab8-228b-4575-8942-cce70f14e6e6