The Recall Desk
HighFDA (Devices)·Z-0124-2026·Announced 2025-10-15

Design Options Pain Management Trays Recalled for Connector Lid Malposition

B. Braun Medical Inc. is recalling Design Options Pain Management Trays because the catheter connector lid may be positioned incorrectly, affecting spinal and epidural anesthesia delivery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall of medical device trays used for spinal and epidural anesthesia. No illnesses or injuries have been reported. The recall addresses a potential defect—incorrect positioning of the catheter connector lid—which poses a risk that the trays may not function properly during procedures. This qualifies as a risk-of-harm product with no reported injuries.

Plain-English summary

B. Braun Medical Inc. is recalling Design Options, Pain Management Trays (Product Code: SESK) due to a potential defect where the catheter connector lid may be in an incorrect position. These are pre-assembled sterile trays used for spinal and epidural anesthesia procedures in hospital settings.

The incorrect positioning of the catheter connector lid could interfere with proper connector assembly or use during the procedure. This malfunction poses a risk that the tray may not function as intended for spinal or epidural catheter placement.

The recall affects 2,450 units distributed nationwide to hospitals and medical centers across all U.S. states. These pre-assembled surgical kits were supplied to numerous facilities including major medical centers.

Healthcare providers and hospitals that received affected trays should stop using them immediately and contact B. Braun Medical Inc. for replacement or return instructions. The affected lots have specific UDI codes and include lot numbers from 0062000738 through 0062014360, expiring July 31, 2026.

The recalled product

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 MAIMONI
Manufacturer
B BRAUN MEDICAL INC
Category
Medical Device — Surgical Anesthesia Trays
Hazard
  • connector-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1. REF: 530029
  • Product Code: SESK
  • UDI-DI (Primary): 04046964305245
  • UDI-DI (Unit of Use): 04046964305238
  • Lot Number: 0062012031. 2. REF: 530048
  • UDI-DI (Primary): 04046964305313
  • UDI-DI (Unit of Use): 04046964305306
  • Lot Number: 0062006298. 3. REF: 530155
  • UDI-DI (Primary): 04046964306211
  • UDI-DI (Unit of Use): 04046964306204
  • Lot Number: 0062012054. 4. REF: 530159
  • UDI-DI (Primary): 04046964669286
  • UDI-DI (Unit of Use): 04046964669279
  • Lot Number: 0062012025. 5. REF: 530169
  • UDI-DI (Primary): 04046964808920
  • UDI-DI (Unit of Use): 04046964808913
  • Lot Number: 0062012035. 6. REF: 530171
  • UDI-DI (Primary): 04046964950391
  • UDI-DI (Unit of Use): 04046964950384
  • Lot Number: 0062006303. 7. REF: 530180

Distribution

Distributed nationwide across the United States.

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