CLASS II ONGOING Device recall · Reported 5 Feb 2025 · FDA Enforcement Report
Design Options Combined Spinal/Epidural Tray- Intended recalled
B. Braun Medical is recalling Design Options Combined Spinal/Epidural Tray- Intended for administration of, distributed nationwide in the US. The recall was initiated on 4 Dec 2024 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-1021-2025
- FDA event ID
- 95874
- Recalling firm
- B. Braun Medical, Allentown, PA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Dec 2024
- FDA classified
- 24 Jan 2025
- Reported
- 5 Feb 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Spinal Implants
Timeline
| 4 Dec 2024 | Recall initiated by company | |
| 24 Jan 2025 | Classified by FDA | +51 days |
| 5 Feb 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Product as listed by the FDA
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to intrathecal space and epidural space for pain control. Model/Catalog Number: 530159
Where it was distributed
US Nationwide distribution in the states of MO, OK.
Questions about this recall
Why was it recalled?
Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. The incorrect catheter connector is smaller than the required catheter connector and therefore is unable to be used to administer medication.
Which lots are affected?
UDI-DI 04046964669286 (Primary); 04046964669279 (Unit of Use); Lot Number 0061916572
Where was it sold?
US Nationwide distribution in the states of MO, OK.
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.
More recalls from B. Braun Medical
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Extension Set Discofix Four Way Stopcock recalled by B Braun Medical | B Braun Medical | Other | Nationwide |
| Drug | ANNOUNCED | B. Braun 0.9% Sodium Chloride Injection USP, in a PAB Container recalledB. Braun | B. Braun Medical | Particulate Matter | Nationwide |
| Drug | CLASS I | Lactated Ringer's Injection USP Excel container recalledLactated Ringers | B Braun Medical | Particulate Matter | Nationwide |
| Device | CLASS I | Design Options Spinal Tray Spinal Needle Anesthesia recalled | B Braun Medical | Processing Deviation | Nationwide |
| Device | CLASS II | Sesk Upmc Double Catheter Tray recalled by B Braun Medical | B Braun Medical | Device Malfunction | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | Avid Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |