The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2655-2026·Announced 2026-07-08

Thoracentesis and Paracentesis Trays Recalled for Deficient Manufacturing

Bard Access Systems, Inc. is recalling three models of thoracentesis and paracentesis trays due to lidocaine ampoules being manufactured under deficient manufacturing practices. The devices are used for fluid removal procedures and have been distributed nationwide and in Belgium.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with deficient manufacturing practices affecting a component (lidocaine ampoules) of the device. No reported illnesses or injuries are stated in the source text, and the hazard is manufacturing-process-related rather than a documented harm to patients.

Plain-English summary

Bard Access Systems, Inc. is recalling thoracentesis and paracentesis trays, which are medical devices indicated for removing fluid from either the pleural or peritoneal spaces during acute drainage and aspiration procedures. The recalled products include the OTP5000 (5FR Non-Valved Tray), PIG1260T (Safe-T-Centesis 6FR x 16cm Tray), and TPT1000 (Thoracentesis/Paracentesis Tray).

The recall is due to lidocaine ampoules included with the trays being manufactured under deficient manufacturing practices by the ampoule manufacturer. Approximately 9,500 units have been distributed worldwide, including nationwide distribution across all U.S. states and to Belgium.

Affected consumers and healthcare facilities should stop using these products immediately. For questions or to report adverse events, healthcare providers and patients should contact Bard Access Systems, Inc. or the FDA.

The recalled product

Product
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…
Manufacturer
Bard Access Systems, Inc.
Category
Medical Device — Drainage / Aspiration Equipment
Hazard
Affected units
9,500

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • OTP5000 THORA/PARA TRAY
  • 5FR

Distribution

Distributed nationwide across the United States.

The notice also names 51 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Bard Access Systems, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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