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Stop using now Medical device recall · FDA · Published December 4, 2024

B. Braun Combined Spinal/Epidural Tray Recall: Incorrect Catheter Connector Risk

B. Braun recalls combined spinal/epidural trays with incorrect catheter connector that can't securely administer medication. Affected units have model 530159 and UDI-DI 04046:696469286. Stop using immediately to prevent medication delivery failure.

🇺🇸 FDA recall #Z-1021-2025Medical deviceB. Braun ›
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Recalling firmB. Braun Medical, Inc.901 Marcon Blvd · Allentown, PA 18109-9512
✎ GovInfoNow plain-language explainer

B. Braun is recalling combined spinal/epidural trays that have a faulty catheter connector. This connector is too small to securely attach to the epidural catheter, which could prevent proper medication delivery during surgery. Affected units pose a risk of medication administration failure. Read more at govinfonow.com/recall/53335-b-braun-combined-spinal-epidural-tray-recall-incorrect-catheter-connector.

Source Summary by GovInfoNow · govinfonow.com/recall/53335-b-braun-combined-spinal-epidural-tray-recall-incorrect-catheter-connector · Updated August 18, 2026 · FDA enforcement record: FDA #Z-1021-2025

Cite this page

“B. Braun Combined Spinal/Epidural Tray Recall: Incorrect Catheter Connector Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/53335-b-braun-combined-spinal-epidural-tray-recall-incorrect-catheter-connector. Based on FDA recall #Z-1021-2025 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1021-2025%22&limit=1).

B. Braun Medical, Inc. recalled Design Options COMBINED SPINAL/EPIDURAL TRAY units nationwide on Dec. 4, 2024, according to the FDA. The hazard involves an incorrect catheter connector that prevents secure connection and medication administration.

How to tell if you have it

  • Brand: B. Braun
  • Product: Design Options COMBINED SPINAL/EPIDURAL TRAY-
  • Model/Catalog Number: 530159
  • Lot Number: 0061916572
  • Distribution: US Nationwide, states of MO, OK

The hazard

The kit contains an incorrect catheter connector that is smaller than required, resulting in an inability to provide a secure connection to the epidural catheter. Consequently, the device cannot be used to administer medication.

Context

GovInfoNow's records show B BRAUN MEDICAL INC has 66 other recalls on record since Oct. 15, 2013. Recent similar recalls include a Sodium Chloride Injection recall for particulate matter (Aug. 19, 2026), a Lactated Ringer's Injection recall for particulate matter (Aug. 12, 2026), and a Discofix Four Way Stopcock recall for an incorrect expiration date (Aug. 4, 2026). Other recent recalls of similar products include a Medline Urethral Catheter Tray recall for catheter detachment risk (May 4, 2026), an Arrow FLEXTIP Plus Epidural Catheter recall for incorrect adhesive manufacturing (March 11, 2026), and a Medline Intermittent Latex Catheter recall for connector detachment risk (May 4, 2026).

How to tell if you have this one

Check for model number 530159 or UDI-DI 04046964669286 (Primary) on the tray. The product was sold with lot number 0061916572.

  • Brand
    B. Braun
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Immediately

    The recalled tray has a faulty connector that cannot securely attach to the epidural catheter, so it must be stopped from use to prevent medication delivery failure.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: nationwideTXFlorida: nationwideFL

FDA distribution: “US Nationwide distribution in the states of MO, OK.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Missouri, Oklahoma.

Recall timeline

FDA published this recall 2 months after the firm started it.

1. Firm started the recall: Dec 4, 202412. FDA classified it Class II: Jan 24, 202523. Published in FDA’s Enforcement Report: Feb 5, 2025320242025
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-1021-2025 (December 4, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1021-2025 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA