Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK — FDA record Z-1260-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Feb 28, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Reason
The external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay, 2) Requirement of an additional device, 3), Needle tip breakage, if used despite incompatibility.
Classification
Class II
Recalling firm
Bard Peripheral Vascular Inc
Quantity
38,635
Agency-reported status
Ongoing
Source record identifier
Z-1260-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityREF/UDI-DI/Lot(Expiration Date): 1610MSK/00801741142567/1445630(11/28/2024), 1449980(12/28/2024), 1451134(1/28/2025); 1816MSK/00801741097065/1447510(12/28/2024), 1447511(12/28/2024), 1447512(12/28/2024), 1447513(12/28/2024), 1448118(12/28/2024), 1448119(12/28/2024), 1448120(12/28/2024), 1448121(12/28/2024), 1448743(12/28/2024), 1450413(12/28/2024), 1450414(12/28/2024), 1451075(1/28/2025), 1451076(1/28/2025), 1451621(1/28/2025), 1451622(1/28/2025), 1451625(1/28/2025), 1451626(1/28/2025), 1453516(1/28/2025), 1453517(1/28/2025), 1454295(1/28/2025), 1456850(2/28/2025), 1456856(2/28/2025), 1457030(2/28/2025)

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide Distribution: US (Nationwide) includes states of: FL, MD, OH, CO, PA, TX, NC, CA, ME, MO, NV, MI, IL, NY, VA, AZ, NH, LA, WI, KY, MA, WA, CT, SD, OK, DC, IA, AR, GA, NE, NM, IN, NJ, MN, PR, AL, AK, SC, KS, OR, ID, VT, MT, WV, ND, TN, MS, HI, WY, RI and OUS countries of: Canada, Korea, Thailand and Taiwan. OUS: AR, AU, BE, CA, CN, CO, HK, IN, JP, KR, TH, TW

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Mar 22, 2023
Recall initiation date
Feb 28, 2023
Center classification date
Mar 16, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

Related records