Recall Z-2270-2026

B Braun Medical Inc · initiated January 29, 2026

Class II Open, Classified

Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature

Product

Brand Name: B. BRAUN MEDICAL INC. Product Name: SESK UPMC DOUBLE CATHETER TRAY Model/Catalog Number: 530134 Software Version: N/A Product Description: SESK UPMC DOUBLE CATHETER TRAY Component: No

Codes / lots: Lot Code: Model No 530134, UDI-DI (Primary Device) 04046964305856, UDI-DI (Unit Device ID) 04046964305849, Lot Number 0062019148

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.

FDA-determined cause: Process control

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;

Details

Recall number
Z-2270-2026
Initiated
January 29, 2026
Posted by FDA
May 29, 2026
Product code
OFT – Spinal Epidural Anesthesia Kit
Quantity
390
Distribution
US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
Recalling firm
B Braun Medical Inc, Bethlehem, PA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-2263-2026 Class IIBrand Name: B. BRAUN MEDICAL INC Product Name: CESK NORTHSIDE ANESTHESIA TRAY…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2264-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: BPSK, BLOCKJOCKS TRAY Model/Catalog…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2265-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: NES1725KFXL SPINAL EPID CLOSED TIP CATH…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2266-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK HARRIS METHODIST Model/Catalog…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2267-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: LYNDON B JOHNSON HOSPITAL SPINAL EPID…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2268-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified
Z-2269-2026 Class IIBrand Name: B. BRAUN MEDICAL INC. Product Name: CESK SHANDS JACKSONVILLE 20055717…B. Braun was notified by our supplier, Ferndale Laboratories, Inc., the manufacturer of MASTISOL Liquid… 01/29/2026Open, Classified