Severity
Moderate
ModerateClass IIOngoing
FDA Devices recall · Reported February 5, 2025
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
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 r…
B. Braun Medical, Inc. recalled Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/a… - a moderate-severity action.
Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/a… was recalled by B. Braun Medical, Inc. in February 5, 2025. Reason: Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epid…. Check the official notice for the remedy. Verify recall #Z-1021-2025 with the FDA Devices before acting.
The recall
B. Braun Medical, Inc. issued this moderate-severity FDA Devices recall-Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epid….
- Moderate
- severity level
- 1K units
- affected scope
- Class II
- classification
- February 5, 2025
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1021-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1021-2025) was formally reported on February 5, 2025, with the manufacturer initiating the action on December 4, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. B. Braun Medical, Inc. is listed as the recalling firm, operating out of Allentown, PA. Federal records list the affected scope as 1090 units.
The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: US Nationwide distribution in the states of MO, OK.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1090 units
Related Recalls
6
3 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Ongoing |
| Recall number | Z-1021-2025 |
| Date reported | February 5, 2025 |
| Date initiated | December 4, 2024 |
| Recalling firm | B. Braun Medical, Inc. |
| Firm location | Allentown, PA |
| Affected scope | 1090 units |
| Distribution | US Nationwide distribution in the states of MO, OK. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1021-2025) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by B. Braun Medical, Inc.. Units affected: 1090 units.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on February 5, 2025. Severity: Moderate. Recall number: Z-1021-2025.
Where was the recalled product distributed? ▼
Distribution: US Nationwide distribution in the states of MO, OK..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1021-2025) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 5, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.