Devicor Mammotome Revolve Biopsy System Recalled for Missing Labeling
Devicor Medical Products Inc is recalling 320 Mammotome Revolve Dual Vacuum Assist Biopsy Systems because they lack required probe labeling, product codes, and sterilization stickers.
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 the hazard involves missing labeling and sterilization stickers, which is a moderate risk of harm but does not meet the criteria for Severe (Class II with hospitalization) or High (high-risk pathogens).
Plain-English summary
Devicor Medical Products Inc is recalling 320 units of the Mammotome Revolve Dual Vacuum Assist Biopsy System. This medical device is used to sample breast tissue identified as suspicious under imaging guidance.
The recall was initiated because the affected devices did not have Revolve Stereo Probe labeling, lacked product codes indicating the size and length of the probe, and were missing sterilization stickers or lot numbers. These labeling deficiencies prevent proper identification and verification of the device's sterilization status.
The devices were distributed worldwide, including in the United States (Iowa, Illinois, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, and West Virginia) and internationally to Chile and Brazil. Healthcare facilities and consumers should stop using these devices and contact Devicor Medical Products Inc for further instructions.
The recalled product
- Product
- Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
- Manufacturer
- Devicor Medical Products Inc
- Category
- Medical Device — Biopsy System
- Affected units
- 320
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)
- F11621304D1
Distribution
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