Pipeline and approval signals
Search agency notices, approvals, recalls, and regulatory updates from global authorities.
89 of 1,114 tracked regulatory updates from 40 agencies and publishers, page 2 of 2.
Device recall: InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030openFDA Device RecallsDevice recall: Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version: Software version 1.2.1 Product Description: The MiniMed Go app for iOS or MiniMed Go app for Android is compatible with the following components: " SimpopenFDA Device RecallsDevice recall: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290openFDA Device RecallsDevice recall: Medtronic Biopsy Needle Kit, REF: 9733068, Passive, Sterile EO, RxonlyopenFDA Device RecallsDevice recall: Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated SequenceropenFDA Device RecallsDevice recall: ROTOR ASSY-SW40, Reference Number 331302, when the rotors are installed in the following centrifuges: Optima XPN-100 (Model Numbers A99846 and A94469), Optima XPN-90 (Model Numbers A99842 and A94468), Optima XPN-80 (Model Numbers A99839 and A95765), Optima XE-100 (Model Numbers A99836openFDA Device RecallsDevice recall: Think Surgical Square Driver REF: 109126openFDA Device RecallsDevice recall: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilatory support.openFDA Device RecallsDevice recall: CareLink Clinic, REF: MMT-7350openFDA Device RecallsDevice recall: Techno-Path Multichem AE Unassayed Level 2 REF: AE622XopenFDA Device RecallsDevice recall: Brand Name: VACUETTE Product Name: LH Lithium Heparin Separator Model/Catalog Number: 454008P Product Description: Greiner VACUETTE Blood Collection Tube with Lithium Heparin and Gel Separator (13 x 75 mm, 3.5ml)openFDA Device RecallsEarly Alert: B. Braun Removes Streamline Bloodline Set for Dialog+FDA MedWatchDrug label update: HEB Cherry Cough DropsopenFDA Drug LabelsDrug label update: BM ColocynthisopenFDA Drug LabelsDrug label update: OxcarbazepineopenFDA Drug LabelsDrug label update: CarbamazepineopenFDA Drug LabelsDrug label update: Sertraline HClopenFDA Drug LabelsDrug label update: LAXATIVEopenFDA Drug LabelsDrug label update: CVS Diphenhydramine HydrochlorideopenFDA Drug LabelsDrug Alerts and StatementsFDA Drug Safety CommunicationsWedgewood Pharmacy Issues Recall of Certain Compounded Veterinary Medications Within Expiry Due to Potential Potency IssuesFDA MedWatchDrug recall: Sermorelin, 1 mg/mL, 10 ml vial, Sterile injectable solution, RX Only, Houston RX LLC, 15430 Vantage Parkway E STE 220, Houston, TX 77032.openFDA Drug RecallsDrug recall: HYDROCORTISONE SODIUM SUCCINATEopenFDA Drug RecallsDrug recall: METOCLOPRAMIDEopenFDA Drug RecallsDevice recall: Medline convenience kit labeled as: FOOT ANKLE. Medline Kit SKU DYNJ65395AopenFDA Device RecallsDevice recall: FORWARD Gunshot Wound Kit; Model: AFT-GSW;openFDA Device RecallsDevice recall: IntelePACS, InteleConnect Portal/Tech Portal Versions PACS-5-1-1-R102, PACS-5-2-1-R93, PACS-5-3-1-R83 through R128, PACS-5-4-1-R66 through R101, PACS-5-5-1-R50 through R89, PACS-5-6-1-R41 through R81, PACS-5-7-1-R21 through R61, PACS-5-8-1-R2 through R42, PACS-5-9-1-R8 through R19; SyopenFDA Device RecallsDevice recall: Convenience Kits containing CONMED AirSeal Access Ports ADVANCE LAPAROSCOPIC DYNJ911135A CHN GYN ONCOLOGY DYNJ906731MopenFDA Device RecallsDevice recall: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Product number/SKU DYNJ04584L; 2) OPEN HEART ACCESSORY PACK, Medline Product number/SKU DYNJT5715A; 3) CABG ACCESSORY PACK, Medline Product number/SKU DYNJ85751; 4) OPEN HEART PACK, Medline Product numopenFDA Device RecallsDevice recall: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.openFDA Device RecallsDevice recall: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, bladder neck, and bladder wall, Reference Part Number 090001-S26, Order Number (GPN) G16112openFDA Device RecallsDevice recall: Generic Name: GORE VIABIL Short Wire Biliary Endoprosthesis; Model/Catalog Number: VSWVH0808 and VSWVN1006 Product Description: The GORE VIABIL Short Wire Biliary Endoprosthesis is a flexible, self-expanding endoprosthesis designed to maintain luminal patency of the common bile duct wopenFDA Device RecallsDevice recall: iFuse TORQ Implant System Model/Catalog Number: 10055T(10x55mm), 10060T(10x60mm), 10065T(10x65mm), 10080T(10x55mm), 11580T(11.5x80mm)openFDA Device RecallsDevice recall: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretchers, Power X2, Item No. 0015816 and PowerX2 Premium, Item No. 0015821openFDA Device RecallsDevice recall: REF: P65 ST862 CoLag SCREW, FT, 6.7X62.5 mmopenFDA Device RecallsDevice recall: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)openFDA Device RecallsDevice recall: DxU 840m Iris, REF: C76947; DxU 850m Iris, REF: C49513openFDA Device RecallsDevice recall: RAPICIDE PA Part A High-Level Disinfectant, Model/Catalog Number: ML020115openFDA Device RecallsDevice recall: Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122005NA Product Description: LIKORALL 242 ES, NATURAL Product Code: 3122006 Product Description: LIKORALL 242 ES, WHITE PopenFDA Device Recalls