Data Foundry

Medical device recalls 2025

Design Options — Class II medical device recall Z-0124-2026

Ongoing recall by B BRAUN MEDICAL INC, reported 2025-10-15, distributed nationwide. Potential for the lid of the catheter connector to be in the incorrect position.

Recall numberZ-0124-2026
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmB BRAUN MEDICAL INC, Allentown, PA, United States
Recall initiated2025-09-18
Classified2025-10-09
Reported by FDA2025-10-15
DistributedNationwide (US)
Quantity2,450 units
UPC / GTIN / UDI-DI04046955156436, 04046955156443, 04046955156511, 04046955156528, 04046955589371, 04046955589388, 04046955619320, 04046955619337, 04046955619368, 04046955619375, 04046964305238, 04046964305245, 04046964305306, 04046964305313, 04046964306204, 04046964306211, 04046964669279, 04046964669286, 04046964808913, 04046964808920, 04046964813986, 04046964813993, 04046964950384, 04046964950391
Lot numbers0062000738, 0062001876, 0062003228, 0062003710, 0062006298, 0062006303, 0062011011, 0062012025, 0062012031, 0062012035, 0062012054, 0062014360
Model numbers530029, 530048, 530155, 530159, 530160, 530169, 530171, 530180, 530184, 530194, 530197, 530199
Expiration dates2026-07-31

Product

Design Options, Pain Management Tray. Product Code: SESK. Product Descriptions: 1. SESK PARKLAND MEMORIAL FX CSE TRAY. 2. SESK OWENSBORO DAVIESS HOSP 20058814. 3. SESK MEMORIAL HEALTH SYSTEM SPINAL/EPID. 4. SESK ST. JOHN'S MERCY MED CTR SPINAL/EPID. 5. SESK MAIMONIDES HOSPITAL SPINAL/EPIDURAL. 6. SESK OU MEDICAL CENTER - SPINAL/EPIDURAL. 7. SESK ELLIS HOSPITAL - SPINAL EPIDURAL. 8. STONY BROOK HSP SPINAL EPIDRAL TRAY SESK. 9. SESK UAB SPINAL EPIDURAL. 10. SESK CREIGHTON UNIV BMH SOINAL EPIDURAL. 11. SESK, BSW SPINAL EPIDURAL TRAY. 12. LYNDON B JOHNSON HOSPITAL SPINAL EPID.

Reason for recall

Potential for the lid of the catheter connector to be in the incorrect position.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0124-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.