FDA recall Z-2267-2026

B Braun Medical Inc · Class II · device

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

Reason for recall

B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL¿ Liquid Adhesive, that they have issued a voluntary recall due to potential cracking of the butyrate tubing (outside tube), which renders the product unusable.

Distribution

US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

Key facts

Status
Ongoing
Initiation date
2026-01-29
Report date
2026-06-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bethlehem, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2267-2026