CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
BD Heyman Follower Coude Tip for following sizes recalled by C.R. Bard
C.R. Bard is recalling BD Heyman Follower Coude Tip for following sizes, distributed nationwide in the US. The recall was initiated on 3 Jun 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2075-2025
- FDA event ID
- 96961
- Recalling firm
- C.R. Bard, Covington, GA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 3 Jun 2025
- FDA classified
- 3 Jul 2025
- Reported
- 9 Jul 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 3 Jun 2025 | Recall initiated by company | |
| 3 Jul 2025 | Classified by FDA | +30 days |
| 9 Jul 2025 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cather packaging may contain the incorrect French size.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Where it was distributed
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
Nationwide AlabamaArkansasArizonaCaliforniaColoradoFloridaGeorgiaIllinoisIndianaKentuckyLouisianaMassachusettsMarylandMaineMichiganMinnesotaMissouriMississippiMontanaNorth Carolina
Questions about this recall
Why was it recalled?
Cather packaging may contain the incorrect French size.
Which lots are affected?
REF:21312- Lot:JUJX0285 /UDI:801741075605; REF:21314- Lot:JUJX1147 /UDI:801741075612; REF: 21316- Lots:JUJY0895 & JUJX1148 /UDI:801741075629
Where was it sold?
Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL, GA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, VT, WI, WV and the country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 96961This product is part of a recall event; the main page for the event is REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra recalled | C.R. Bard | Packaging Defects | Nationwide | |
| CLASS II | BD Heyman Follower Straight Tip for following sizes recalled | C.R. Bard | Packaging Defects | Nationwide |
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All 123| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Temperature Abuse | Nationwide |
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| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |