Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0735-2017·Announced 2016-12-21

C.R. Bard Recalls 70cc Irrigation Syringes Due to Package Defect

C.R. Bard is recalling 452,728 units of 70cc irrigation syringes because a package defect 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 involves 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 rating.

Plain-English summary

C.R. Bard, Inc. is recalling 452,728 units of BARD Irrigation Syringes (70cc) with Resectoscope Tip, Catheter Tip, Luer Adapter, and Cap. The recall is due to a package defect where a slit on the package may affect the product's sterility.

The affected syringes are single-use plastic devices with a 70cc capacity, intended for Cytoscope or Resectoscope irrigation, catheter irrigation, and Foley catheter balloon inflation. The specific lot numbers involved are NGZC3768, NGZC5029, NGZD0924, NGZD1664, NGZD1983, NGZD3103, NGZD3241, NGZD3989, NGZD4053, GZD4923, NGZE1190, NGZE2134, NGZE3406, NGZF0305, NGZF1546, NGZF2589, NGZF3934, NGZF4488, and NGZF4889.

The products were distributed nationwide in the United States and internationally to Australia, New Zealand, Canada, Mexico, France, and Italy. Healthcare providers and facilities should check their inventory for the listed lot numbers and stop using the affected syringes.

The recalled product

Product: BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, 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…
Manufacturer: C.R. Bard, Inc.
Category: Medical Device — Syringes
Hazard: sterility-compromise
packaging-defect
Affected units: 452,728

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 (19)

Product Code: 0038460
Lot Numbers: NGZC3768
NGZC5029
NGZD0924
NGZD1664
NGZD1983
NGZD3103
NGZD3241
NGZD3989
NGZD4053
GZD4923
NGZE1190
NGZE2134
NGZE3406
NGZF0305
NGZF1546
NGZF2589
NGZF3934
NGZF4488 and NGZF4885.

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