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Week of Dec 15, 2025

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Dec 15, 2025device pma248d agoETHICON, Inc. — ETHIZIA (PMA)

Product code: SGV. Advisory committee: SU. Decision: APPR

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Dec 15, 2025device pma248d agoVentana Medical Systems, Inc. — HER2 Dual ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

Supplement type: Normal 180 Day Track. Product code: NYQ. Advisory committee: PA. Decision: APPR

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Dec 15, 2025device pma248d agoMedibeacon, Inc. — MediBeacon® Transdermal GFR Measurement System (TGFR) (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: SDK. Advisory committee: GU. Decision: APPR

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Dec 15, 2025device pma248d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Dec 15, 2025device pma248d agoScibase AB — Nevisense (PMA supplement)

Supplement type: 30-Day Notice. Product code: ONV. Advisory committee: SU. Decision: OK30

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Dec 15, 2025device pma248d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Dec 15, 2025device pma248d agoRoche Molecular Systems, Inc. — COBAS HPV TEST (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

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Dec 15, 2025device recall248d agoImmunotech A.S. device recall (Cls II)AIM ImmunoTech Inc.

Estrone RIA, REF: DSL8700 — Reason: The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause Temporary injury of Remote probability. Only in some (very rare) cases may the issue occur. — Status: Ongoing

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Dec 15, 2025device recall248d agoIntuitive Surgical, Inc. device recall (Cls II)INTUITIVE SURGICAL INC

da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box) — Reason: Access Port System tray may develop cracks potentially resulting in a sterility breach. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10F; Model Number: 722002; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoSunMed Holdings, LLC device recall (Cls I)Sagent Pharmaceuticals Inc

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No — Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10/10; Model Number: 722027; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20; Model Number: 722028; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Product Name: Allura Xper FD10C; Model number: 722001; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10; Model Number: 722003; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines) — Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. — Status: Ongoing

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Dec 15, 2025device recall248d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines) — Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10/10; Model Number: 722011; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/20; Model Number: 722038; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoLEASEIR TECHNOLOGIES SLU device recall (Cls II)

Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and destroying them without unnecessary damage to surrounding tissue. This is achieved by controlled emission of laser radiation to the target tissue. The system consists of a main console and two interchangeable applicators that delivers pulsed light in the range of 800-820nm with a peak in the 810nm in different spot sizes. Two of the applicators emitting radiation at 810 nm wavelength for two areas 13.5¿15 mm¿ and 14.5¿25.5 mm¿. Two different operation modes are available: static mode and dynamic mode, which are differentiated basically by the frequency range defined for each mode (1-4 Hz for static and 10 Hz for dynamic). The principle of operation consists in the photons travel along the axis and reflected again back into the crystal, continuing the chain reaction, while photons travelling in different directions leave the crystal. In one of the two mirrors, a tiny hole allows a small amount of light to leak out and the resulting beam is focused with lenses and is emitted from the laser. The total energy emitted by the Leaseir MHR Xcell is produced by an array of diodes. The laser emission is activated by the hand piece trigger, deliver a continuous pulse pattern while the button is pressed. Component: NO — Reason: The console label for affected devices is missing the "DANGER" symbol. — Status: Ongoing

Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10/10; Model Number: 722005; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20; Model Number: 722012; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoDiagnostica Stago, Inc. device recall (Cls II)

Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA. — Reason: Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20/10; Model Number: 722029; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021003 (Philippines) — Reason: Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed. — Status: Ongoing

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Dec 15, 2025device recall248d agoSunMed Holdings, LLC device recall (Cls I)Sagent Pharmaceuticals Inc

Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No — Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10; Model Number: 722010; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoSysmex America, Inc. device recall (Cls II)

TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17 — Reason: Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane; Model Number: 722008; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoSunMed Holdings, LLC device recall (Cls I)Sagent Pharmaceuticals Inc

Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no — Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. — Status: Ongoing

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Dec 15, 2025device recall248d agoICU Medical, Inc. device recall (Cls II)ICU MEDICAL INC/DE

Plum Duo Infusion System, List Number 40002-04-01 — Reason: ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs. — Status: Ongoing

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Dec 15, 2025device recall248d agoSunMed Holdings, LLC device recall (Cls I)Sagent Pharmaceuticals Inc

Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No — Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. — Status: Ongoing

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Dec 15, 2025device recall248d agoHologic, Inc device recall (Cls II)

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. — Reason: Presence of particulates in affected devices that can be deposited into breast tissue during use. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 OR Table; Model Number: 722023; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20 Biplane; Model Number: 722013; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoWilson-Cook Medical Inc. device recall (Cls II)

Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 — Reason: Nasal feeding tube packaged without the nasal transfer tube component. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD10; Model Number: 722026; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025device recall248d agoPHILIPS MEDICAL SYSTEMS NEDERLAND B.V. device recall (Cls II)

Allura Xper FD20; Model Number: 722006; — Reason: Philips has identified that in a limited number of impacted systems the drip tray beneath the cooling unit was not installed under previous field corrections, or evidence of the implementation was not adequately documented. If it is not installed, there is a potential for coolant liquid to contact electrical components. This could lead to electrical short-circuits, which may trigger system fuses and result in system shutdown. — Status: Ongoing

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Dec 15, 2025grant248d agoJACKSON LABORATORY — Genetic dissection of microglia functions in complement-mediated synapse loss...

AG grant. $716,579. PI: Erik Bradley Bloss

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Dec 15, 2025grant248d agoUNIVERSITY OF VIRGINIA — Model-Based Syllabic Prediction in the Avian Auditory PalliumUniversity of Virginia

DC grant. $41,394. PI: Bao Le

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Dec 15, 2025grant248d agoRUTGERS BIOMEDICAL AND HEALTH SCIENCES — The Role of APP-metabolites on Extracellular Vesicle Cargo and Function

AG grant. $639,838. PI: MARC D TAMBINI

full page →nih reporter ↗

Dec 15, 2025grant248d agoCLEVELAND CLINIC LERNER COM-CWRU — Endothelial TLR2/4 signaling in sex dimorphism of pathological angiogenesis a...

AG grant. $659,309. PI: Tatiana V Byzova

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Dec 15, 2025grant248d agoUNIVERSITY OF MISSOURI-COLUMBIA — Targeting LARP6 in aging-associated heart failure

AG grant. $429,394. PI: Shawn Brady Bender

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Dec 16, 2025approval247d agoTIZANIDINE HYDROCHLORIDE — FDA approvalTIZANIDINE HYDROCHLORIDE

Sponsor: APOTEX INC. Form: CAPSULE. Route: ORAL

full page →TIZANIDINE HYDROCHLORIDE →fda approvals ↗

Dec 16, 2025approval247d agoHYMPAVZI (MARSTACIMAB-HNCQ) — FDA approvalmarstacimab

Sponsor: PFIZER INC. Form: INJECTABLE. Route: SUBCUTANEOUS

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Dec 16, 2025approval247d agoEXDENSUR (DEPEMOKIMAB-ULAA) — FDA approvaldepemokimab

Sponsor: GLAXOSMITHKLINE LLC. Form: INJECTION

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Dec 16, 2025approval247d agoHYDROXYZINE HYDROCHLORIDE — FDA approvalHYDROXYZINE HYDROCHLORIDE

Sponsor: NOVITIUM PHARMA. Form: SYRUP. Route: ORAL

full page →HYDROXYZINE HYDROCHLORIDE →fda approvals ↗

Dec 16, 2025approval247d agoFLUTICASONE PROPIONATE — FDA approvalFluticasone Propionate Glenmark

Sponsor: AUROBINDO PHARMA LTD. Form: SPRAY, METERED. Route: NASAL

full page →Fluticasone Propionate Glenmark →fda approvals ↗

Dec 16, 2025approval247d agoLOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (HYDROCHLOROTHIAZIDE) — FDA approvalAlembic Pharmaceuticals Inc

Sponsor: ALEMBIC PHARMS LTD. Form: TABLET. Route: ORAL

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Dec 16, 2025approval247d agoCARIPRAZINE HYDROCHLORIDE — FDA approvalCARIPRAZINE HYDROCHLORIDE

Sponsor: AUROBINDO PHARMA LTD. Form: CAPSULE. Route: ORAL

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