Dexcom Uncovers Theft of Scrapped Product, Notifies Potentially Impacted Users
Summary Company Announcement Date: May 26, 2026 FDA Publish Date: May 29, 2026 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Sensors identified as scrap were diverted and sold by third-party Company Name: Dexcom, Inc. Brand Name:...MTS A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype
STN: 103756Proper Name: Blood Grouping Reagent Combination KitTradename: MTS A/B; MTS A/B/D; MTS A/B/D/Reverse and MTS Monoclonal Rh Phenotype CardManufacturer: Micro Typing Systems, Inc, In Vitro Blood Banking ReagentFor in vitro diagnostic use onlyFor the detection...KayserBetten Issues Correction for KayserBett IDA Beds
This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The FDA has identified this recall as the most serious type. This device may cause serious injury or death if you continue to use it without...Streamlined nonclinical studies
Submit Comments by 07/30/2026 Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written...
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