Z-2265-2026Class II

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

Name: Z-2265-2026 Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number...
Creator: B Braun Medical Inc
Published: 2026-01-29
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2026-01-29 / Open, Classified / root cause: manufacturing process

FDA source

B Braun Medical Inc began a recall of Brand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH Model/Catalog Number: 530201 Software Version: N/A Product Description... on 2026-01-29. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2265-2026
Classification: Class II
Status: Open, Classified
Initiated: 2026-01-29
Posted: 2026-05-29
Recalling firm: B Braun Medical Inc
Product: 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
Product code: OFT Spinal Epidural Anesthesia Kit
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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];
Quantity in commerce: 1730
Distribution: US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
Product codes and lots: Lot Code: Model No 530201, UDI-DI (Primary Device) 04046955672196, UDI-DI (Unit Device ID) 04046955672189, Lot Number 0062010965

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2265-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2263-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2264-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2265-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2266-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2267-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2268-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2269-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29
Z-2270-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-05-29

Product code OFT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)