Bard Access Systems, Inc. recalls 4380 ECONOMY SOFT TISSUE BIOPSY TRAY

Recalling company

Bard Access Systems, Inc.

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

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

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

May 21, 2026

Reported

Jul 8, 2026

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.

Status

Ongoing

Quantity

11,990

Lot / codes

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 Lot Number: REKY3390 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108501 Lot Numbers: REKY3393 REJZ0942 REJZ0943

Company location

Salt Lake City, UT

Recall type

Voluntary: Firm initiated

Recall number

Z-2668-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2668-2026 in the FDA Enforcement Report. Also see FDA recall press releases.