Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Sof

FDA device recall Z-2265-2026 · posted 2026-05-29 · Open, Classified

Recall details

Recalling firm

B Braun Medical Inc

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.

Action taken

On January 29, 2026 and May 6, 2026 URGENT MEDICAL DEVICE RECALL letters were sent to customers to notify them of a recall of a kit component. Actions to be taken include to review inventory to identify affected product, discontinue use and segregate. Using the acknowledgement form, respond to B Braun who will send further instructions to return the product. Should there be any questions, comments, or concerns regarding the product you have received, please feel free to contact (844-903-6417) or recalls@bbraunusa.com;

Root cause

Process control

Status

Open, Classified

Product code

OFT

Quantity affected

1730

Distribution

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

Date initiated

2026-01-29

Date posted

2026-05-29

Location

Bethlehem, PA