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Design Options recallZ-2265-2026 · B Braun Medical Inc · initiated Jan 29, 2026

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Process control

What the company is doing

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 [email protected];

Recall details

Recall number
Z-2265-2026
Status
Open, Classified
Initiated by the company
Jan 29, 2026
Posted by the FDA
May 29, 2026
Recalling firm
B Braun Medical Inc
Quantity
1730
Product code
OFT
Distribution
US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.

Product description

Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description: NES1725KFXL SPINAL EPID CLOSED TIP CATH Component: No

Code information (models, lots, serial numbers)

Lot Code: Model No 530201, UDI-DI (Primary Device) 04046955672196, UDI-DI (Unit Device ID) 04046955672189, Lot Number 0062010965

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 98862).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page