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Week of Oct 27, 2025

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Oct 30, 2025device recall290d agoInpeco S.A. device recall (Cls II)

FlexLab (FLX); Version: FLX-217-10; — Reason: The Aliquoter Module (mALX) may generate secondary sample tubes without labels or with mismatched labels which may result in delayed results or erroneous results. This error occurs if the operators open the printer head of mALX to perform error recoveries or maintenance procedures and do not empty the printer tubes buffer to remove all the secondary sample tubes. — Status: Ongoing

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: FOR SOLUTION. Route: ORAL

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Oct 31, 2025approval289d agoVOQUEZNA TRIPLE PAK (AMOXICILLIN) — FDA approvalamoxicillin + clarithromycin + vonoprazan

Sponsor: PHATHOM. Form: CAPSULE, TABLET, TABLET. Route: ORAL

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Oct 31, 2025approval289d agoVOQUEZNA DUAL PAK (AMOXICILLIN) — FDA approvalamoxicillin + vonoprazan fumarate

Sponsor: PHATHOM. Form: CAPSULE, TABLET. Route: ORAL

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

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Oct 31, 2025approval289d agoPENICILLIN V POTASSIUM — FDA approvalNorthstar Rx LLC

Sponsor: CHARTWELL RX. Form: TABLET. Route: ORAL

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Oct 31, 2025device 510k289d agoApplied Medical Resources Corp. — Kii Structural Balloon Access System (510k cleared)

Product code: GCJ. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Oct 31, 2025device 510k289d agoApplied Medical Resources Corporation — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator) (510k cleared)

Product code: GEI. Advisory committee: General, Plastic Surgery. Type: Traditional

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Oct 31, 2025device 510k289d agoVigodent Indústria E Comercio Ltda — Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); (510k cleared)

Product code: ELW. Advisory committee: Dental. Type: Traditional

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Oct 31, 2025device 510k289d agoPhasor Health, LLC — GREEN (510k cleared)

Product code: HBE. Advisory committee: Neurology. Type: Traditional

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Oct 31, 2025device 510k289d agoPropper Manufacturing Co., Inc. — Chex-All Sterilization Pouches and Tubes (510k cleared)Simpson Manufacturing Co., Inc.

Product code: FRG. Advisory committee: General Hospital. Type: Abbreviated

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Oct 31, 2025device 510k289d agoActuated Medical, Inc. — GripTract-GI Endoscopic Tissue Manipulator Upper GI Model GT-GS100 (510k cleared)

Product code: FDS. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Oct 31, 2025device 510k289d agoPersyst Development, LLC — Persyst 15 EEG Review and Analysis Software (Persyst 15 (P15)) (510k cleared)

Product code: OMB. Advisory committee: Neurology. Type: Traditional

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Oct 31, 2025device 510k289d agoCanon Medical Systems Corporation — Aplio i900, Aplio i800 and Aplio i700 Software V9.0 Diagnostic Ultrasound System (510k cleared)

Product code: IYN. Advisory committee: Radiology. Type: Traditional

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Oct 31, 2025device 510k289d agoTerrats Medical SL — DESS Dental Smart Solutions (510k cleared)

Product code: NHA. Advisory committee: Dental. Type: Traditional

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Oct 31, 2025device 510k289d agoOrthofix US, LLC — Firebird SI Navigation System (510k cleared)

Product code: OLO. Advisory committee: Neurology. Type: Traditional

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Oct 31, 2025device 510k289d agoBecton, Dickinson and Company — BD Enteric Bacterial Panel for BD COR System, BD Enteric Bacterial Panel plus for BD COR System, and Enteric Bacterial Panel Diluent for BD COR System (510k cleared)BECTON DICKINSON & CO

Product code: PCI. Advisory committee: Microbiology. Type: Traditional

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Oct 31, 2025device 510k289d agoCeribell, Inc. — Ceribell Instant EEG Headcap (Small: C251, Medium: C252) (510k cleared)Ceribell, Inc.

Product code: GXY. Advisory committee: Neurology. Type: Abbreviated

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Oct 31, 2025device 510k289d agoSanhe Meditech Co., Ltd. — Diode Laser Hair Removal Machine (GLD01) (510k cleared)

Product code: GEX. Advisory committee: General, Plastic Surgery. Type: Traditional

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Oct 31, 2025device 510k289d agoMedacta International S.A. — MSS - Humeral reverse liners extension (510k cleared)Stemedica International S.A.

Product code: PHX. Advisory committee: Orthopedic. Type: Traditional

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Oct 31, 2025device 510k289d agoMaxx Orthopedics, Inc. — Freedom Metaphyseal Cone Implants (Metaphyseal Cones) (510k cleared)

Product code: MBH. Advisory committee: Orthopedic. Type: Traditional

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Oct 31, 2025device 510k289d agoPulsenmore, Ltd. — Pulsenmore ES (510k cleared)Pulsenmore Ltd.

Product code: SGJ. Advisory committee: Radiology. Type: Direct

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Oct 31, 2025device 510k289d agoShenzhen Sanping Image Technology Co., Ltd. — Flexible Ureterorenoscope system (Electronic Endoscope Image Processor, model: SP-TXCLQ12.1, Flexible Ureterorenoscope, model: SP-SNGSYJ 2.0, SP-SNGSYJ 2.2, SP-SNGSYJ 2.5, SP-SNGSYJ 2.8) (510k cleared)

Product code: FGB. Advisory committee: Gastroenterology, Urology. Type: Traditional

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Oct 31, 2025device pma289d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: Normal 180 Day Track. Product code: NPW. Advisory committee: CV. Decision: APPR

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP90. Product Number: M8010A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP30. Product Number: M8002A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX800. Product Number: 865240. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips Ultrasound, LLC device recall (Cls II)Ocuvex Therapeutics Inc

Lumify Diagnostic Ultrasound System models : 795005, 795161, 989605449841, — Reason: Ultrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX700. Product Number: 865241. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX500. Product Number: 866064. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX850. Product Number: 866470. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoStryker Corporation device recall (Cls II)STRYKER CORP

NICO BrainPath; Product Number/Product Name NN-8024 BrainPath Shephard's Hook - Greenberg; NN-8025 BrainPath Shephard's Hook - Sugita; NN-8026 BrainPath Shephard's Hook - Budde; NN-8042 BrainPath Shephard's Hook - Greenberg LK; — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing

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Oct 31, 2025device recall289d agoStryker Corporation device recall (Cls II)STRYKER CORP

NICO Myriad Handpiece Product Number/Product Name: NN-8000 15x10 MHP; NN-8001 15x 13 MHP; NN-8002 15x 25 MHP - MINOP; NN-8003 13x10 MHP; NN-8004 13x13 MHP; NN-8005 15x25 MHP GAAB; NN-8006 11X10 MHP; NN-8007 11x13 MHP; NN-8008 19x28 MHP OI; NN-8010 17x31.5 MHP DECQ; NN-8015 NICO Fluid System (NFS); NN-8017 11x13 MHP/PB; NN-8018 13X13 MHP/PB; NN-8019 19x28 MHP Little LOTTA; NN-8020 19x21.5 MHP PaediScope; NN-8021 15x26.5 MHP LOTTA; NN-8500 15x10 MHP; NN-8501 15x13 MHP; NN-8502 15x25 MINOP MHP; NN-8503 13x10 MHP; NN-8504 13x13 MHP; NN-8505 15x25 GAAB MHP; NN-8506 11X10 MHP; NN-8507 11x13 MHP; NN-8508 19x28 OI MHP; NN-8510 17x31.5 DECQ MHP; NN-8517 13X13 MHP/PB; NN-8518 11x13 MHP/PB; NN-8519 19x28 Little LOTTA MHP; NN-8520 19x21.5 PaediScope MHP; NN-8521 15X26.5 LOTTA MHP; — Reason: Tape used to secure components within packaging contains latex, despite products being labeled as latex-free. Latex could potentially cause an allergic reaction. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP2. Product Number: M8102A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP50. Product Number: M8004A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP80. Product Number: M8008A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX100. Product Number: 867033. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP40. Product Number: M8003A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoAizu Olympus Co., Ltd. device recall (Cls II)

Olympus OER-Elite — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Multi Measurement Server X2. Product Number: M3002A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP60. Product Number: M8005A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP5. Product Number: M8105A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP20. Product Number: M8001A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX600. Product Number: 865242. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoStryker Medical Division of Stryker Corporation device recall (Cls II)

Stryker Arise 1000EX mattress, Part Number 2236000000 — Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. — Status: Ongoing

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Oct 31, 2025device recall289d agoStryker Medical Division of Stryker Corporation device recall (Cls II)

Stryker MV3 bariatric bed, Part Number 5900000001 — Reason: Stryker has issued a voluntary recall of certain MV3 beds and Arise 1000EX mattresses because some of these products have been sold in close proximity, suggesting a potential intent for them to be used together. These products have not been tested for compatibility and thus are not designed to be used together. The combination of both is not recommended by Stryker. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX400. Product Number: 866060. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Multi-Measurement Module X3. Product Number: 867030. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall289d agoAizu Olympus Co., Ltd. device recall (Cls II)

Olympus OER-Pro — Reason: Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance. — Status: Ongoing

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Oct 31, 2025device recall289d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX550. Product Number: 866066. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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