Data Foundry

Medical device recalls 2025

Design Options — Class II medical device recall Z-0126-2026

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-0126-2026
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)
Quantity5,770 units
UPC / GTIN / UDI-DI04046955056897, 04046955056903, 04046955057771, 04046955057788, 04046955127795, 04046955127801, 04046955127832, 04046955127849, 04046955127856, 04046955127863, 04046955184071, 04046955186402, 04046955214419, 04046955214426, 04046955243037, 04046955264407, 04046955589432, 04046955589449, 04046955589470, 04046955589487, 04046955596096, 04046955596102, 04046955596133, 04046955596140, 04046955596157 and 35 more
Lot numbers0061983245, 0061994277, 0061999998, 0062000125, 0062003111, 0062003214, 0062003706, 0062005198, 0062006292, 0062006293, 0062006304, 0062006313, 0062006317, 0062006384, 0062012017, 0062012043, 0062013246, 0062013260, 0062013265, 0062014364, 0062014368, 0062016181, 0062017605, 0062017607, 0062017615, 0062017625, 0062017630, 0062017634, 0062017951, 0062019003
Model numbers551028, 551474, 551630, 551749, 551769, 551998, 552006, 552076, 552113, 552116, 552119, 552123, 552126, 552133, 552135, 552136, 552147, 552152, 552153, 552174, 552176, 552177, 552179, 552180, 552192 and 5 more
Expiration dates2026-07-31

Product

Design Options, PERIFIX FX Epidural Anesthesia Tray. Product Code: CESK. Product Descriptions: 1. CESK ROBERT WOOD JOHNSON UNIV HOSP. 2. CESK EAST JEFFERSON GEN HOSP 20071769. 3. CESK FLETCHER ALLEN HOSPITAL. 4. CESK WASHOE MEDICAL CENTER. 5. CESK DETROIT MEDICAL CTR 20064586. 6. CESK ALBANY MEDICAL CENTER. 7. CESK EPIDURAL BLOCK TRAY. 8. CESK, BSW EPIDURAL TRAY. 9. CESK HOWARD COUNTY GENERAL. 10. CESK CE17TKFC10L. 11. CESK WILLIAMSON MEDICAL CENTER. 12. CESK FLORIDA HOSPITAL. 13. CESK RIVERSIDE HEALTH SYSTEM. 14. CESK MAYO CLINIC OB. 15. CESK PRESBYTERIAN HOSPITAL DALLAS. 16. CESK HOUSTON METHODIST HOSPITAL. 17. CESK OHIO STATE UNIV MEDICAL CENTER. 18. CESK NORTONS WOMEN'S AND CHILDREN'S. 19. CESK BEN TAUB. 20. CESK PENN MEDICINE CONTINUOUS-ORIG CUST. 21. CESK ALLEGHENY GENERAL HOSPITAL. 22. CESK UNIVERSITY OF ILLINOIS MED CTR. 23. CESK RUSH UNIVERSITY MEDICAL CENTER. 24. CESK ST. JOSEPH MEDICAL CENTER. 25. CESK INTEGRIS HEALTH. 26. CESK UMASS MEMORIAL. 27. CESK STANFORD UNIV HOSP 20054718. 28. CESK OVERLAKE HOSPITAL. 29. CESK CHRIST HOSPITAL 20057985. 30. CESK NEWTON-WELLESLEY HOSPITAL.

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-0126-2026. 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.