CLASS II ONGOING Device recall · Reported 17 Jan 2024 · 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 8 Nov 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-0643-2024
- FDA event ID
- 93578
- Recalling firm
- Bard Peripheral Vascular, Tempe, AZ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 8 Nov 2023
- FDA classified
- 5 Jan 2024
- Reported
- 17 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 8 Nov 2023 | Recall initiated by company | |
| 5 Jan 2024 | Classified by FDA | +58 days |
| 17 Jan 2024 | 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
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission Kit 18G x 20CM; 1825MSK/ Mission Kit 18G x 25CM; 2010MSK/ Mission Kit 20G x 10CM; 2016MSK/ Mission Kit 20G x 16CM; 2020MSK/ Mission Kit 20G x 20CM
Where it was distributed
Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
The internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula may exceed the stated length on the label. As a result, the biopsy needle may not fit properly into the coaxial cannula, preventing access to the target tissue, which could lead to tissue injury, longer and repeat procedures.
Which lots are affected?
REF/UDI-DI/Lot (Expiration Date): 1410MSK/ 00801741142543/ 0001418630(05/28/24), 0001429851(07/28/24), 0001433778(08/28/24), 0001441794(10/28/24), 0001443076(10/28/24, 0001446454(11/28/24, 0001451131(01/28/25, 0001452840(01/28/25, 0001463142(03/28/25, 0001468867(04/28/25, 0001475757(06/28/25, 0001481508(07/28/25, 0001485193(08/28/25, 0001487094(08/28/25, 0001488512(08/28/25, 0001491080(09/28/25, 0001491583(09/28/25, 0001498859(11/28/25, 0001502349(12/28/25); 1416MSK/ 00801741142550/0001402196(01/28/24), 0001423061(06/28/24), 0001430525(07/28/24), 0001434059(08/28/24), 0001435619(09/28/24), 0001452376(01/28/25), 0001458437(02/28/25), 0001464693(03/28/25), 0001464694(03/28/25); 1610MSK/ 00801741142567/0001390419(10/28/23), 0001392740(10/28/23), 0001402197(01/28/24), 0001415815(04/28/24), 0001418632(05/28/24), 0001426735(06/28/24), 0001426839(07/28/24), 0001430408(07/28/24), 0001430528(07/28/24), 0001433779(08/28/24), 0001468480(04/28/25), 0001468479(04/28/25), 0001474221(05/28/25), 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Where was it sold?
Worldwide - US Nationwide distribution including in the states of PR, IL, MA, GA, KY, CA, TX, PA, IA, MN, NH, MD, FL, ID, IN, AL, VA, CO, WI, NY, NV, OK, OH, WA, MI, MS, AZ, HI, SD, NJ, NE, MT, NC, DC, CT, WY, UT, TN, LA, NM, SC, VT, MO, ME, AR, OR, KS, RI, AK, WV, DE, ND, PR, GU and the countries of CA, BE, AU, KR, SG, CN, TH, HK, VI, VN, AR, JP, CL, IN, TW, CO, MX, DO, BR, BD, MM, PK, NP, PA.
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 Bard Peripheral Vascular
All 139| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | EnCor EnCompass Breast Biopsy and Tissue Removal System Console recalled | Bard Peripheral Vascular | Device Malfunction | Nationwide |
| Device | CLASS II | Broviac 4. Single-Lumen CV Catheter Cutdown Tray recalled | Bard Peripheral Vascular | Sterility | Nationwide |
| Device | CLASS II | Safe-T-Centesis Catheter Drainage Tray recalled | Bard Peripheral Vascular | Other | Nationwide |
| Device | CLASS II | Venclose digiRF Generators recalled by Bard Peripheral Vascular | Bard Peripheral Vascular | Temperature Abuse | Nationwide |
| Device | CLASS I | Rotarex Atherectomy System and Instructions for Use recalled | Bard Peripheral Vascular | Device Malfunction | Nationwide |
Other Other Medical Devices recalls
All 13,908| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Plastics Tray kits recalled by Avid Medical | Avid Medical | Foreign Material | Nationwide |
| Device | CLASS II | Heart Prep Tray kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Pack Open Heart Cfh kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Sperm Ab Elisa (96 well plate test) recalled by DRG International | DRG International | Other | Nationwide |
| Device | CLASS III | BeneView Series recalled by Mindray DS USA | Mindray DS USA | Device Malfunction | Nationwide |