- Recalling firm
- Bard Access Systems, Inc.
- Reason for recall
- Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
- Affected products (lot / model / serial)
- 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
- Units affected
- 11,990
- Distribution pattern
- 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 location
- Salt Lake City, UT, United States
- Recall type
- Voluntary: Firm initiated
- How the firm notified customers
- Letter
- Product type
- Devices
- Status
- Ongoing
- Recall number
- Z-2668-2026
- Recall initiated
- May 21, 2026
- FDA classification date
- July 2, 2026
- FDA report date
- July 8, 2026
- FDA event ID
- 99096
- Last updated on HTM Vibe
- July 23, 2026