CLASS II ONGOING Device recall · Reported 9 Jul 2025 · FDA Enforcement Report
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra recalled
C.R. Bard is recalling REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra, 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-2076-2025
- 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
REF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
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?
Lot # NGJX2513/UDI: 00801741000294
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 96961| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | BD Heyman Follower Straight Tip for following sizes recalled | C.R. Bard | Packaging Defects | Nationwide | |
| CLASS II | BD Heyman Follower Coude Tip for following sizes recalled by C.R. Bard | C.R. Bard | Packaging Defects | Nationwide |
More recalls from C.R. Bard
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 |
Other Other Medical Devices recalls
All 13,857| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Peds Sinus Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
| Device | CLASS II | SmartPath to dStream for XR and 3.0T recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Achieva 1.5T, Achieva 1.5T Conversion recalled by Philips North America | Philips North America | Device Malfunction | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Mfc Craniotomy Pack recalled | Medline Industries | Other | Nationwide |