CLASS II ONGOING Device recall · Reported 17 May 2023 · FDA Enforcement Report
Bard Mission Disposable Core Biopsy Instrument Kit recalled
Bard Peripheral Vascular is recalling Bard Mission Disposable Core Biopsy Instrument Kit, distributed nationwide in the US. The recall was initiated on 11 Apr 2023 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-1564-2023
- FDA event ID
- 91838
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Apr 2023
- FDA classified
- 5 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 11 Apr 2023 | Recall initiated by company | |
| 5 May 2023 | Classified by FDA | +24 days |
| 17 May 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
Product as listed by the FDA
Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK, 20G x 10CM; REF: 2016MSK, 20G x 16CM
Where it was distributed
US Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
Coaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the biopsy needle from properly fitting into the coaxial cannula and accessing the target tissue, which could lead to procedure delay, and insufficient sample acquisition requiring a repeat procedure.
Which lots are affected?
REF/UDI-DI/Lot (Expiration Date): 2010MSK/00801741097089/0001445946(11/28/2024), 2016MSK/00801741097096/1458844(02/28/2025)
Where was it sold?
US Nationwide Distribution: PR, AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY . OUS: BE, CA, AU
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.
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