FDA Medical devices recall ·
Design Options, Pain Management Tray recall
- Recall number
- Z-0124-2026
- Date
- (initiated September 18, 2025)
- Company / brand
- B Braun Medical Inc
861 Marcon Blvd, Allentown, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,450 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
Potential for the lid of the catheter connector to be in the incorrect position.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
1. REF: 530029; Product Code: SESK; UDI-DI (Primary): 04046964305245; UDI-DI (Unit of Use): 04046964305238; Lot Number: 0062012031. 2. REF: 530048; Product Code: SESK; UDI-DI (Primary): 04046964305313; UDI-DI (Unit of Use): 04046964305306; Lot Number: 0062006298. 3. REF: 530155; Product Code: SESK; UDI-DI (Primary): 04046964306211; UDI-DI (Unit of Use): 04046964306204; Lot Number: 0062012054. 4. REF: 530159; Product Code: SESK; UDI-DI (Primary): 04046964669286; UDI-DI (Unit of Use): 04046964669279; Lot Number: 0062012025. 5. REF: 530169; Product Code: SESK; UDI-DI (Primary): 04046964808920; UDI-DI (Unit of Use): 04046964808913; Lot Number: 0062012035. 6. REF: 530171; Product Code: SESK; UDI-DI (Primary): 04046964950391; UDI-DI (Unit of Use): 04046964950384; Lot Number: 0062006303. 7. REF: 530180; Product Code: SESK; UDI-DI (Primary): 04046955156443; UDI-DI (Unit of Use): 04046955156436; Lot Number: 0062000738. 8. REF: 530197; Product Code: SESK; UDI-DI (Primary): 04046955619337; UDI-DI (Unit of Use): 04046955619320; Lot Number: 0062003710. 9. REF: 530194; Product Code: SESK; UDI-DI (Primary): 4046955589388; UDI-DI (Unit of Use): 4046955589371; Lot Number: 0062014360. 10. REF: 530199; Product Code: SESK; UDI-DI (Primary): 04046955619375; UDI-DI (Unit of Use): 04046955619368; Lot Number: 0062001876. 11. REF: 530160; Product Code: SESK; UDI-DI (Primary): 04046964813993; UDI-DI (Unit of Use): 04046964813986; Lot Number: 0062011011. 12. REF: 530184; Product Code: SESK; UDI-DI (Pri
Distribution
Nationwide distribution to AK, AL, AR, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV.
States: Alaska Alabama Arkansas Arizona California Colorado Florida Georgia Hawaii Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Maine Michigan Minnesota Missouri Mississippi North Carolina Nebraska New Jersey New Mexico New York Ohio Oklahoma Oregon Pennsylvania South Carolina South Dakota Tennessee Texas Utah Virginia Washington Wisconsin West Virginia
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0124-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.