CLASS II Device recall · Reported 20 Jul 2016 · FDA Enforcement Report
Mammotome Revolve Dual Vacuum Assist Biopsy System recalled
Devicor Medical Products is recalling Mammotome Revolve Dual Vacuum Assist Biopsy System, distributed in 26 states. The recall was initiated on 19 May 2016 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-2211-2016
- FDA event ID
- 74297
- Recalling firm
- Devicor Medical Products, Cincinnati, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 May 2016
- FDA classified
- 14 Jul 2016
- Reported
- 20 Jul 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 19 May 2016 | Recall initiated by company | |
| 14 Jul 2016 | Classified by FDA | +56 days |
| 20 Jul 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.
Where it was distributed
Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
AlabamaArkansasCaliforniaConnecticutDistrict of ColumbiaFloridaGeorgiaIllinoisKansasKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMississippiNorth CarolinaNew JerseyNew York
Questions about this recall
Why was it recalled?
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
Which lots are affected?
MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.
Where was it sold?
Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.
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 | Sterility | 8 states |
Other Hip & Knee Implants recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |