Recall Z-2668-2026— Bard Access Systems, Inc.

Name: FDA recall Z-2668-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-21

Class II · Ongoing

Class II FDA medical device recall by Bard Access Systems, Inc., initiated 2026-05-21. It names one FDA 510(k) clearance: K813338. 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..

Recalling firm: Bard Access Systems, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-05-21
Firm location: Salt Lake City, UT, United States

510(k) clearances named in this recall

1 on FDA's record

K813338 — BIOPSY NEEDLES & TRAYSAmerican Pharmaseal Div. Ahsc·cleared 1982-01-28

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product 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.).

Reason for recall

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.