FDA recall Z-2668-2026

Bard Access Systems, Inc. · Class II · device

Product

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 The Soft Tissue Biopsy devices are indicated for use in the collection of aspirate tissue (e.g. liver, kidney, etc.).

Reason for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Distribution

Worldwide U.S. Nationwide distribution including in the states of 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, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The country of Belgium.

Key facts

Status
Ongoing
Initiation date
2026-05-21
Report date
2026-07-08
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2668-2026