FDA Medical Device Recalls (openFDA)
RECORDATI RARE DISEASES INC.: Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
- Recall number
- Z-2012-2025
- Recalling firm
- RECORDATI RARE DISEASES INC.
- Product
- Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
- Status
- Open, Classified
- Initiated
- 2025-06-11
- Posted
- 2025-06-23
- Terminated
- not on file
- Reason
- Out of specification stability test result for the Caphosol B solution from process validation lots
- Root cause
- Device Design
- Action
- Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.
- Quantity
- 3,754 boxes (120,128 doses)
- Distribution
- Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.
- Lot, serial or model codes
- UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10
- 510(k) numbers
- ["K234015"]
- PMA numbers
- not on file
- Product code
- LFD
- Firm FEI
- 3027554269
- Firm city
- Bridgewater
- Firm state
- NJ
- 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