The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0126-2026·Announced 2025-10-15

Custom epidural anesthesia trays recalled over catheter connector lid position

B. Braun is recalling 5,770 Design Options PERIFIX FX Epidural Anesthesia Trays because the lid of the catheter connector may be in the incorrect position.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: Scored 2 because the record describes a component position defect without stating a hazard, clinical consequence or reported harm.

Plain-English summary

Design Options PERIFIX FX Epidural Anesthesia Trays, product code CESK, are being recalled because of the potential for the lid of the catheter connector to be in the incorrect position. The affected configurations include the CESK Robert Wood Johnson University Hospital, CESK East Jefferson General Hospital 20071769, CESK Fletcher Allen Hospital and CESK Washoe Medical Center trays.

The recall covers 5,770 units, including REF 551028 with primary UDI-DI 04046964306334 and unit-of-use UDI-DI 04046964306327. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.

The enforcement record describes the connector lid position and does not state any injury or clinical consequence. Facilities should check affected lots and follow B. Braun's instructions.

The recalled product

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…
Manufacturer
B BRAUN MEDICAL INC
Category
Medical Device — Anesthesia tray
Hazard
Affected units
5,770

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: 551028
  • Product Code: CESK
  • UDI-DI (Primary): 04046964306334
  • UDI-DI (Unit of Use): 04046964306327
  • Lot Number: 0062017630. 2. REF: 551474
  • UDI-DI (Primary): 04046964306938
  • UDI-DI (Unit of Use): 04046964306921
  • Lot Number: 0062006292. 3. REF: 551630
  • UDI-DI (Primary): 04046964307560
  • UDI-DI (Unit of Use): 04046964307546
  • Lot Number: 0062017605. 4. REF: 551749: Product Code: CESK
  • UDI-DI (Primary): 04046964307942
  • UDI-DI (Unit of Use): 04046964307935
  • Lot Number: 0062017615. 5. REF: 551769: Product Code: CESK
  • UDI-DI (Primary): 04046964308024
  • UDI-DI (Unit of Use): 04046964308017
  • Lot Number: 0062006304. 6. REF: 551998: Product Code: CESK
  • UDI-DI (Primary): 04046964310942
  • UDI-DI (Unit of Use): 04046964310928
  • Lot Number: 0062014368. 7. REF: 552006: Product Code: CESK

Distribution

Distributed nationwide across the United States.

The notice also names 39 states specifically:

Part of a larger recall action

This product is one of 13 recalled by B BRAUN MEDICAL INC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

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