Z-1260-2023Class II

Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK

Name: Z-1260-2023 Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Creator: Bard Peripheral Vascular Inc
Published: 2023-02-28
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2023-02-28 / Open, Classified

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK on 2023-02-28. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-1260-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-02-28
Posted: 2023-03-16
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM, REF: 1610MSK; 18G x 16CM, REF: 1816MSK
Product code: KNW Instrument, Biopsy
Reason for recall: 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.
FDA root cause: Mixed-up of materials/components
Action: On 2/28/23, "URGENT MEDICAL DEVICE RECALL" notices were mailed and emailed to customers and distributors who were told to take the following actions: 1) Discontinue use of and Dispose of all affected product remaining in your possession in accordance with your local facility's process. 2) Share this notification with all users within your facility network of the product to ensure they are also aware of this field action. 3) If you purchased this product from a distributor, contact your distributor for further instructions and credit resolution. 4) Complete and return the attached Customer Response Form and email to: [email protected] The recalling firm will issue replacements, as available, or credit. In addition, distributors were asked to do the following: Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification. Customers/distributors who have questions can contact the North American Regional Complaint Center at 1-844-8BD- LIFE (1-844-823-5433), Say Recall when prompted, M-F 8am - 5pm CT
Quantity in commerce: 38,635
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
Product codes and lots: REF/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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1260-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1260-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-03-22	2023-03-16

Product code KNW

K171953Class IIBard Mission Disposable Core Biopsy InstrumentBard Peripheral Vascular, Inc. / cleared 2017-09-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)