FDAClass II · Medical device · Recalled July 8, 2026

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code recall — Bard Access Systems, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2668-2026
Brand: Bard Access Systems
Classification: Class II
Units affected: 11,990
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

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.).

Affected products

4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code

Companies & origin

Recalling firm location: Salt Lake City, UT, United States
Firm address: 605 N 5600 W, N/A, 84116-3738

Identifying details (verbatim from the notice)

Product codes / lots: 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
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.
Firm notified the public via: Letter
FDA event ID: 99096
Recall initiated: May 21, 2026
FDA classified: July 2, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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