Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2267-2026·Announced 2026-06-10

B. Braun spinal epidural kits contain Mastisol with cracking tubing

B. Braun Lyndon B Johnson Hospital spinal epidural kits are being recalled because they contain Mastisol Liquid Adhesive whose butyrate tubing may crack, rendering it unusable.

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: FDA Class II recall where the described consequence is that the component becomes unusable rather than any patient hazard, which fits the Moderate band.

Plain-English summary

The B. Braun Medical Inc. Lyndon B Johnson Hospital Spinal Epidural kit, model/catalog number 530184, is being recalled. The action covers 620 units.

B. Braun was notified by its supplier, Ferndale Laboratories, Inc., the manufacturer of Mastisol Liquid Adhesive, that Ferndale has issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable. The FDA classified the action as Class II. The source does not describe any patient hazard beyond the product being unusable.

Distribution was within the United States, in Alabama, Florida, Pennsylvania, Texas, Virginia and Washington. The kits are supplied to healthcare facilities rather than sold to consumers.

Facilities should identify affected kits using the model number and UDI-DI codes in the recall notice and follow the instructions issued by B. Braun.

The recalled product

Product: Brand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID Model/Catalog Number: 530184 Software Version: N/A Product Description: LYNDON B JOHNSON HOSPITAL SPINAL EPID Component: No
Manufacturer: B Braun Medical Inc
Category: Medical Device — Procedure kit
Hazard: component-defect
cracking-tubing
supplier-recall
class-ii
Affected units: 620

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 (4)

Lot Code: Model No 530184
UDI-DI (Primary Device) 04046955156528
UDI-DI (Unit Device ID) 04046955156511
Lot Number 0062019858

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · B Braun Medical Inc

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