FDAJune 11, 2025device
Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Out of specification stability test result for the Caphosol B solution from process validation lots
What to do
FDA enforcement status: Ongoing
Brands named
recordati rare diseasesrecordatirecordati rare
UPCs
5060146293129
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDACDC, Influenza A/H5 Subtyping Kit, Model/Catalog Number: FluIVD03-112024-04-26
- FDAMedtronic Medical Device Identification Card for SureScan pacemaker patients. The front of this card identifies the implanted pacing system components currently registered to the patient. The back of the card lists patient's following physician as well as specific messaging regarding the MR condi...2015-09-15
- FDAMedtronic CryoConsole, models 106A3, 106E2, and 106A2-K For use in performing cardiac ablation procedures.2015-09-01
- FDACovidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT80803...2015-03-23
- FDAMedtronic Dual Chamber Temporary External Pacemaker, Model 5392. Product Usage: The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand...2015-03-17
- FDAMedtronic, 10 Fr FlexCath Select Steerable Sheath 990065. The FlexCath Select Steerable Sheath (10 Fr Select) is used for percutaneous catheter introduction into the vasculature and chambers of the heart. The sheath is a single-use device and is not implantable.2015-02-23
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