FDAClass II · Medical device · Recalled July 8, 2026

OTP5000 THORA/PARA TRAY recall — Bard Access Systems, Inc.

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

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2655-2026
Brand: Bard Access Systems
Classification: Class II
Units affected: 9,500
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

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.

Affected products

OTP5000 THORA/PARA TRAY

Companies & origin

Recalling firm location: Salt Lake City, UT, United States
Firm address: 605 N 5600 W, N/A, 84116-3738

Identifying details (verbatim from the notice)

Product codes / lots: 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
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 notified the public via: Letter
FDA event ID: 99096
Recall initiated: May 21, 2026
FDA classified: July 2, 2026
FDA report date: July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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