CLASS II Device recall · Reported 11 Mar 2020 · FDA Enforcement Report
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound recalled
Bard Peripheral Vascular is recalling Bard Biopsy EnCor Probe, Stereotactic/Ultrasound, distributed in 30 states. The recall was initiated on 3 Jan 2020 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-1431-2020
- FDA event ID
- 84929
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Jan 2020
- FDA classified
- 3 Mar 2020
- Reported
- 11 Mar 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Imaging Equipment
Timeline
| 3 Jan 2020 | Recall initiated by company | |
| 3 Mar 2020 | Classified by FDA | +60 days |
| 11 Mar 2020 | 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
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
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
Bard Biopsy EnCor Probe, Stereotactic/Ultrasound 7G, REF number ECP017G, packaged individually in sterile pouches, 5 pouches/carton, Single Use, Rx, Sterile.
Where it was distributed
Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
ArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaIowaIllinoisIndianaKansasKentuckyMassachusettsMarylandMichiganMinnesotaMissouriMississippiNorth Carolina
Questions about this recall
Why was it recalled?
Lot numbers and products inadvertently not included in the scope of the previous recall. Original recall was conducted due to an increase in probe failures for leaks, suction issues, and failure to obtain samples.
Which lots are affected?
Lot numbers VTCT0268, VTCT0269, VTCT0270, VTCT0271, VTCU0340, and VTCU0341. UDI numbers: (01)00801741086281(17)200601(10)VTCT0268, (01)00801741086281(17)200601(10)VTCT0269, (01)00801741086281(17)200601(10)VTCT0270, (01)00801741086281(17)200601(10)VTCT0271, (01)00801741086281(17)200601(10)VTCU0340, and (01)00801741086281(17)200601(10)VTCU0341.
Where was it sold?
Distribution was made to AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Canada, Australia, Austria, Belgium, China, Czech Republic, Germany, France, Georgia, Greece, Hong Kong, Israel, Italy, Japan, Korea, Netherlands, New Zealand, Poland, Portugal, Russia, Saudi Arabia, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
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.
Other products in this recall event
3 other products · FDA event 84929This product is part of a recall event; the main page for the event is Bard Biopsy EnCor Probe, MRI Trocar Tip recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Bard Biopsy EnCor Probe, MRI Trocar Tip recalled | Bard Peripheral Vascular | Packaging Defects | 30 states | |
| CLASS II | Bard Biopsy EnCor Probe, MRI Trocar Tip recalled | Bard Peripheral Vascular | Packaging Defects | 30 states | |
| CLASS II | Bard Biopsy EnCor Probe, MRI Blunt Tip recalled | Bard Peripheral Vascular | Packaging Defects | 30 states |
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