{"url_path":"/fda/device/recalls/Z-2668-2026","section_key":"summary","section_title":"DEVICE Recall: Bard Access Systems, Inc. — 4380\tECONOMY SOFT TISSUE BIOPSY TRAY  UDI-DI Code: 0110885403108563    4382A\tSOFT 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.).","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-05-21","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2668-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Bard Access Systems, Inc."},"word_count":180,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-2668-2026\n\n**Recalling firm:** Bard Access Systems, Inc.\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-05-21\n**Report date:** 2026-07-08\n\n## Product\n4380\tECONOMY SOFT TISSUE BIOPSY TRAY  UDI-DI Code: 0110885403108563    4382A\tSOFT 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.).\n\n## Reason\nDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.\n\n## Affected lots\n4380 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\n\n## Distribution\nWorldwide 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."}