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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
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 23, 2026 at 11:04 PM UTC.
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