← FDA ENFORCEMENT
Z-2655-2026Class II

Bard Access Systems, Inc.

Recalling firm
Bard Access Systems, Inc.
Product type
Device
Status
Ongoing
Report date
2026-07-08
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 state
UT
Product quantity
9,500
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPA
Reason for recall

Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by supplier.

Product description

OTP5000 THORA/PARA TRAY, 5FR, NON-VALVED UDI-DI Code: 0110885403284748 PIG1260T SAFE-T-CENTESIS TRAY 6FR X 16CM UDI-DI Code: 0110885403108365 TPT1000 THORACENTESIS/PARACENTESIS TRAY UDI-DI Code: 0110885403108488 The Acute Drainage devices are indicated for use in removing fluid from either the pleural or peritoneal spaces during an acute drainage / aspiration procedure.

Code / lot info

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

Other recalls SPEQ maps to Risk Management & CAPA
2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.2026-07-22Class IAbiomed, Inc.
See all Risk Management & CAPA recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.