FDA-Device2026-07-08Class IIPROCESSING DEFECT
Bard Access Systems soft tissue biopsy trays recalled for defective lidocaine ampoules
What this means
Bard Access Systems is recalling soft tissue biopsy trays (Models 4380 and 4382A) because the lidocaine ampoules included in the kits were manufactured under deficient manufacturing practices. The affected trays are used by healthcare providers to collect tissue samples from patients.
- If you use these biopsy trays in a clinical setting, check the lot numbers (REKY3390, REKY3393, REJZ0942, REJZ0943) against your inventory.
- Do not use affected trays until you receive guidance from Bard Access Systems or your hospital's medical device representative.
- Contact your supplier or Bard Access Systems for instructions on return or replacement.
The agency's original wording
Hazard
Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.
Intended for
Adults
Illnesses reported
None reported
Sold states
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.
Affected count
11,990
Manufactured in
605 N 5600 W, N/A, Salt Lake City, UT, United States
Products
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.).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2668-2026More Bard Access Systems, Inc. recalls
- FDA-Device2026-07-08Bard Access Systems Power-Trialysis dialysis catheters recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Access Systems PowerPICC catheters recalled for deficient lidocaine manufacturing
- FDA-Device2026-07-08Bard Access Systems PowerMidline Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Groshong NXT ClearVue Catheter recalled for deficient lidocaine ampoule manufacturing
- FDA-Device2026-07-08Bard Access Systems thoracentesis and paracentesis trays recalled for deficient lidocaine manufacturing
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.