CLASS II Device recall · Reported 29 Mar 2017 · FDA Enforcement Report
Mammotome Revolve Dual Vacuum Assist Biopsy System recalled
Devicor Medical Products is recalling Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast, distributed in 8 states. The recall was initiated on 28 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1512-2017
- FDA event ID
- 76603
- Recalling firm
- Devicor Medical Products, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2017
- FDA classified
- 21 Mar 2017
- Reported
- 29 Mar 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Imaging Equipment
Timeline
| 28 Feb 2017 | Recall initiated by company | |
| 21 Mar 2017 | Classified by FDA | +21 days |
| 29 Mar 2017 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
Where it was distributed
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
IowaIllinoisNew YorkOhioOklahomaPennsylvaniaTennesseeWest Virginia
Questions about this recall
Why was it recalled?
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Which lots are affected?
F11621304D1
Where was it sold?
Worldwide Distribution - US including IA, IL, NY, OH, OK, PA, TN & WV. Internationally to Chile and Brazil
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Devicor Medical Products
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | HydroMARK Breast Biopsy Site Marker recalled by Devicor Medical Products | Devicor Medical Products | Packaging Defects | Nationwide |
| Device | CLASS II | HydroMARK Breast Biopsy Marker recalled by Devicor Medical Products | Devicor Medical Products | Other | Nationwide |
| Device | CLASS III | Neoprobe GDS Control Unit recalled by Devicor Medical Products | Devicor Medical Products | Device Malfunction | OH |
| Device | CLASS II | Mammotome Revolve Dual Vacuum Assist Biopsy System recalled | Devicor Medical Products | Packaging Defects | 26 states |
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| Device | CLASS II | Merge PACS and Merge OrthoPACS recalled by Merge Healthcare | Merge Healthcare | Labeling Errors | Nationwide |
| Device | CLASS II | Philips Azurion recalled by Philips Medical Systems | Philips Medical Systems Nederl | Potency & Assay |