FDA Medical Device Recalls (openFDA)
B Braun Medical Inc: Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
- Recall number
- Z-2268-2026
- Recalling firm
- B Braun Medical Inc
- Product
- Brand Name: B. BRAUN MEDICAL INC. Product Name: CESK RIVERSIDE HEALTH SYSTEM Model/Catalog Number: 552126 Software Version: N/A Product Description: CESK RIVERSIDE HEALTH SYSTEM Component: No
- Status
- Open, Classified
- Initiated
- 2026-01-29
- Posted
- 2026-05-29
- Terminated
- not on file
- Reason
- 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
- 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 recalls@bbraunusa.com;
- Quantity
- 690
- Distribution
- US Nationwide distribution in the states of AL, FL, PA, TX, VA, WA.
- Lot, serial or model codes
- Lot Code: Model No 552126, UDI-DI (Primary Device) 04046955056903, UDI-DI (Unit Device ID) 04046955056897, Lot Number 0062031274
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OGE
- Firm FEI
- 2521402
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28