Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0738-2017·Announced 2016-12-21

C.R. Bard Recalls BARDIA 60cc Piston Irrigation Syringes Due to Package Defect

C.R. Bard is recalling BARDIA 60cc Piston Irrigation Syringes because a slit defect in the packaging may compromise product sterility.

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: The recall is classified as FDA Class II, and the hazard is a potential loss of sterility due to a packaging defect. No illnesses or injuries are reported in the source text, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

C.R. Bard, Inc. is recalling BARDIA 60cc Piston Irrigation Syringes, sterile, prescription-only devices. The recall is due to a package defect where a slit in the packaging may affect the sterility of the product.

The affected product is a single-use plastic syringe with a 60cc or 70cc capacity graduated barrel, designed for catheter irrigation, Cytoscope or Resectoscope irrigation, and Foley catheter balloon inflation. The recall includes specific lot numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494, and NGZF4014, under product code 802065.

The products were distributed worldwide, including nationwide in the United States and internationally to Australia, New Zealand, Canada, Mexico, France, and Italy. Healthcare providers and patients should check their inventory and discontinue use of the affected lots if a packaging defect is observed.

The recalled product

Product: BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are…
Manufacturer: C.R. Bard, Inc.
Category: Medical Device — Syringes
Hazard: sterility-compromise
packaging-defect

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 (9)

Product Code: 802065
Lot Numbers: NGZC4950
NGZD2121
NGZD4043
NGZD4876
NGZE2323
NGZE3389
NGZF0189
NGZF2494 and NGZF4014.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by C.R. Bard, 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 4 products in this recall →

Same manufacturer · C.R. Bard, Inc.

See all →

High
C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
Moderate
C.R. Bard Recalls Foley Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls SureStep Foley Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16
High
C.R. Bard Recalls SureStep Catheter Trays Due to Wipe Contamination
FDA (Devices) · 2026-09-16

Same hazard · sterility compromise