BD Heyman Followers and Urologist's Trays Recalled for Incorrect Size Labeling

Agency Publication Date: July 3, 2025

Summary

C.R. Bard Inc. is recalling 63 units of BD Heyman Follower Straight Tip catheters, BD Heyman Follower Coude Tip catheters, and Bard Urologist's Trays. The recall was initiated because the packaging may contain a medical device with an incorrect "French size" (the diameter of the catheter) than what is printed on the label. Using the wrong size catheter during a procedure could lead to medical complications or delays. Healthcare providers should stop using the affected products and contact the manufacturer to arrange for their return.

Risk

If a healthcare provider uses a catheter that is a different size than what is labeled, it could cause physical trauma, internal injury, patient discomfort, or the failure of a urological procedure meant to clear an obstructed urethra.

What You Should Do

This recall affects BD Heyman Follower Straight Tip catheters, BD Heyman Follower Coude Tip catheters, and Bard Urologist's Trays distributed worldwide, including 39 U.S. states and Canada.
Check your medical supplies for catheters with REF numbers 21110, 21112, 21114, 21120, 21312, 21314, 21316, or 123400. See the Affected Products section below for the full list of affected codes.
Stop using the recalled medical devices immediately and quarantine any remaining stock to prevent accidental use.
Contact C.R. Bard Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected units.
Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this safety alert.

Your Remedy Options

Other Action

Manufacturer initiated correction/removal via letter.

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BD Heyman Follower Straight Tip

Variants: 10Fr, 12Fr, 14Fr, 20Fr

Model / REF:

21110

21112

21114

21120

Lot Numbers:

JUJX0267

JUJX0258

JUJV0864

JUJW5009

JUJY9171

UDI:

801741075506

801741075513

801741075520

801741075551

Follower for obstructed urethra procedures.

Product: BD Heyman Follower Coude Tip

Variants: 12Fr, 14Fr, 16Fr

Model / REF:

21312

21314

21316

Lot Numbers:

JUJX0285

JUJX1147

JUJY0895

JUJX1148

UDI:

801741075605

801741075612

801741075629

Curved tip follower for urological use.

Product: Bard Urologist's Tray, For the Obstructed Urethra

Model / REF:

123400

Lot Numbers:

NGJX2513

UDI:

00801741000294

Complete tray for urological procedures.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96961

Status: Active

Manufacturer: C.R. Bard Inc

Sold By: Authorized Medical Distributors; Direct Hospital Sales

Manufactured In: United States

Units Affected: 63 units

Distributed To: Alabama, Arkansas, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Wisconsin, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects BD Heyman Follower Straight Tip catheters, BD Heyman Follower Coude Tip catheters, and Bard Urologist's Trays distributed worldwide, including 39 U.S. states and Canada.

Check your medical supplies for catheters with REF numbers 21110, 21112, 21114, 21120, 21312, 21314, 21316, or 123400. See the Affected Products section below for the full list of affected codes.

Stop using the recalled medical devices immediately and quarantine any remaining stock to prevent accidental use.

Contact C.R. Bard Inc. or your authorized distributor to arrange for the return, replacement, or correction of the affected units.

Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for more information regarding this safety alert.

Affected Products

Product: BD Heyman Follower Straight Tip

Variants: 10Fr, 12Fr, 14Fr, 20Fr

Model / REF:

21110

21112

21114

21120

Lot Numbers:

JUJX0267

JUJX0258

JUJV0864

JUJW5009

JUJY9171

UDI:

801741075506

801741075513

801741075520

801741075551

Follower for obstructed urethra procedures.

Product: BD Heyman Follower Coude Tip

Variants: 12Fr, 14Fr, 16Fr

Model / REF:

21312

21314

21316

Lot Numbers:

JUJX0285

JUJX1147

JUJY0895

JUJX1148

UDI:

801741075605

801741075612

801741075629

Curved tip follower for urological use.

Product: Bard Urologist's Tray, For the Obstructed Urethra

Model / REF:

123400

Lot Numbers:

NGJX2513

UDI:

00801741000294

Complete tray for urological procedures.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96961

Status: Active

Manufacturer: C.R. Bard Inc

Sold By: Authorized Medical Distributors; Direct Hospital Sales

Manufactured In: United States

Units Affected: 63 units