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Week of Oct 27, 2025

38

Oct 29, 2025device recall271d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Outlook set utilized in gravity IV administration sets and pump administration sets utilized with BBMI's Infusomat Space Large Volume Pump, Outlook Pump, and Vista Basic Pump. Labeled as the following with corresponding catalog number: 1. OUTLOOK PUMP SET 3 CARESITE LADS 133 IN.; Catalog Number: 490564. — Reason: Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion). — Status: Ongoing

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Oct 30, 2025device recall270d agoCepheid device recall (Cls II)

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing

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Oct 30, 2025device recall270d agoOlympus Corporation of the Americas device recall (Cls I)

Brand Name: Single Use Ligating Device Product Name: Olympus HX-400U-30 Model/Catalog Number: HX-400U-30 Used with an Olympus endoscope to deliver a nylon loop snare. — Reason: Potential that the ligation loop was unable to release or detach as expected during use, causing the loop to become unintentionally fixed around patient anatomy. — Status: Ongoing

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Oct 30, 2025device recall270d agoCepheid device recall (Cls II)

Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 — Reason: Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. — Status: Ongoing

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Oct 30, 2025device recall270d agoInpeco S.A. device recall (Cls II)

FlexLab (FLX); Version: FLX-217-40; — 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 30, 2025device recall270d 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, 2025device recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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 recall269d 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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Oct 31, 2025device recall269d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX750. Product Number: 866471. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall269d agoAizu Olympus Co., Ltd. device recall (Cls II)

Olympus OER-Mini — 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 recall269d agoPhilips North America Llc device recall (Cls II)

IntelliVue Patient Monitor MX450. Product Number: 866062. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Oct 31, 2025device recall269d agoStryker Corporation device recall (Cls II)STRYKER CORP

NICO Myriad Illumination Pack Product No. NN-1000 11g Illumination Sleeve/Fiber; Product No. NN-1001 13g Illumination Sleeve/Fiber — 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 recall269d agoPhilips North America Llc device recall (Cls II)

IntelliVue MP70. Product Number: M8007A. — Reason: Potential issue where the IntelliVue monitors did not alarm. — Status: Ongoing

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Nov 2, 2025device recall267d agoMedtronic MiniMed, Inc. device recall (Cls II)Medtronic USA Inc

MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid under the skin. The MiniMed 780G system includes SmartGuard technology, which can be programmed to automatically adjust insulin delivery based on continuous glucose monitoring (CGM) sensor glucose values and can suspend delivery of insulin when the SG value falls below or is predicted to fall below predefined threshold values. — Reason: A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery. — Status: Ongoing

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Week of Nov 3, 2025

12

Nov 3, 2025device recall266d agoGET TESTED INTERNATIONAL AB device recall (Cls II)

Food Intolerance Test Small — Reason: Distribution without premarket approval/clearance. — Status: Ongoing

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Nov 3, 2025device recall

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