- 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)
- OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 Lot Number: REKY3402 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 Lot Number: REKY3397 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 Lot Number: REKY3386
- Units affected
- 9,500
- 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-2655-2026
- 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