The Recall Desk
HighFDA (Devices)·Z-2075-2025·Announced 2025-07-09

BD Heyman Coude Tip Catheters Recalled for Incorrect French Size Labeling

C.R. Bard Inc. is recalling BD Heyman Follower Coude Tip catheters (12Fr, 14Fr, 16Fr) due to incorrect French size labeling on product packaging.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving mislabeling of catheter packaging. While no illnesses or injuries have been reported, incorrectly-labeled catheters constitute a risk-of-harm product where clinical complications could occur if the wrong size is selected for patient use.

Plain-English summary

C.R. Bard Inc. is recalling BD Heyman Follower Coude Tip catheters in sizes 12Fr, 14Fr, and 16Fr. The affected catheters are from the following lots: 12Fr (Lot JUJX0285), 14Fr (Lot JUJX1147), and 16Fr (Lots JUJY0895 and JUJX1148).

The recall has been issued because the catheter packaging may contain the incorrect French size label.

The affected catheters were distributed nationwide throughout the United States and in Canada.

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 — Urinary Catheter
Hazard
  • incorrect-labeling
  • sizing-mismatch

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.

Related recalls

Same category