The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2075-2025·Announced 2025-07-09

BD Heyman Coude Tip Catheters Recalled Over French Size Labeling Error

C.R. Bard Inc is recalling certain BD Heyman Follower Coude Tip catheters because the packaging may display the incorrect French size, which could lead to use of the wrong size device.

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 involving a labeling error on a medical device. The incorrect French size on packaging could lead to use of the wrong catheter size, but no injuries or adverse events have been reported, which aligns with the Moderate severity criteria for minor labeling errors on risk-of-harm products without reported injury.

Plain-English summary

C.R. Bard Inc is recalling specific lots of the BD Heyman Follower Coude Tip catheters in 12Fr, 14Fr, and 16Fr sizes. The recall was initiated because the product packaging may contain the incorrect French size designation.

The affected products include REF 021312 (Lot JUJX0285), REF 021314 (Lot JUJX1147), and REF 021316 (Lots JUJY0895 and JUJX1148). These are prescription medical devices used by healthcare professionals.

Distribution was worldwide, including US nationwide distribution across numerous states and in Canada. No information about patient injuries or adverse events has been provided in the recall notice.

Healthcare facilities and distributors should review their inventory and contact C.R. Bard Inc regarding the recalled lots. Consumers or patients with questions should consult their healthcare provider.

The recalled product

Product
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Manufacturer
C.R. Bard Inc
Category
Medical Device — Catheter
Hazard

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 (3)

  • REF:21312- Lot:JUJX0285 /UDI:801741075605
  • REF:21314- Lot:JUJX1147 /UDI:801741075612
  • REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

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