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Week of Feb 2, 2026

20

Feb 2, 2026device recall178d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 2, 2026device recall178d agoB Braun Medical Inc device recall (Cls II)B. Braun Medical Inc

Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A — Reason: The potential for the needle tip to be dull/blunt, difficult to advance, and/or break. — Status: Ongoing

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Feb 3, 2026device recall177d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05 — Reason: Impactor handle may be missing cross-pin — Status: Ongoing

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Feb 3, 2026device recall177d agoGE Medical Systems, LLC device recall (Cls II)

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP — Reason: There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. — Status: Ongoing

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Feb 3, 2026device recall177d agoExactech, Inc. device recall (Cls II)

Brand Name: Equinoxe Product Name: Equinoxe Core Instrument Kit Model/Catalog Number: KIT-311X — Reason: Impactor handle may be missing cross-pin — Status: Ongoing

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Feb 3, 2026device recall177d agoIon Beam Applications S.A. device recall (Cls II)

IBA Proton Therapy System - PROTEUS 235 — Reason: It was identified that eh Universal Beam Triggering Interface (UBTI) is disabled in the Therapy Safety System (TSS) configuration. In this condition, the TSS does not interrupt the beam delivery if the Healthy Signal from an external gating device is lost. This may lead to a risk of mistreatment when external gating devices are used. — Status: Ongoing

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Feb 4, 2026device recall176d agoDiagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing

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Feb 5, 2026device recall175d agoDiagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 00515 Product Description: The STA¿ - Liatest ¿ D-Di kit is an immuno-turbidimetric assay for the quantitative determination of D-dimer in venous plasma (in 3.2 % sodium citrate) for use on STA-R¿, STA Compact¿ and STA Satellite¿ analyzers by professional laboratory personnel. The STA¿ - Liatest¿ D-Di is intended for use in conjunction with a clinical pretest probability (PTP) assessment model to exclude pulmonary embolism (PE) and deep venous thrombosis (DVT) in outpatients suspected of PE or DVT. Component: No — Reason: After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range. — Status: Ongoing

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Feb 5, 2026device recall175d agoRemel, Inc device recall (Cls II)

Campy CVA Medium 100/PK, R01272 — Reason: Customer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium. — Status: Ongoing

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Feb 6, 2026device recall174d agoTrividia Health, Inc. device recall (Cls I)HENRY SCHEIN INC

Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX PRO Meter Only/RE4H01P-40, TRUE METRIX PRO Starter Kit/RE4H01P-43, PROCURE TRUE METRIX PRO Meter Only/RE4212P-00, Henry Schein TRUE METRIX PRO Meter Only/RE4099P-40, Henry Schein TRUE METRIX PRO Kit/RE4099P-43, McKESSON TRUE METRIX PRO Meter Only/RE4051P-00, Moore Medical TRUE METRIX PRO Meter Only/RE4068P-01. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing

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Feb 6, 2026device recall174d agoInternational Life Sciences device recall (Cls II)

Artelon FlexBand Dynamic Matrix Ref: 31057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing

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Feb 6, 2026device recall174d agoTrividia Health, Inc. device recall (Cls I)

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX AIR Kit/REA4001-01, Leader TRUE METRIX AIR Kit/REA4002-01, CVS TRUE METRIX AIR Kit/REA4007-01, GNP TRUE METRIX AIR Kit/REA4011-01, Meijer TRUE METRIX AIR Kit/REA4019-01, Publix TRUE METRIX AIR Kit/REA4020-01, Discount Drug Mart TRUE METRIX AIR Kit/REA4025-01, HEB TRUE METRIX AIR Kit/REA4031-01, SunmarkTRUE METRIX AIR Kit/REA4054-01, Rite AidTRUE METRIX AIR Kit/REA4066-01, Centerwell TRUE METRIX AIR Kit/REA4081-01, HumanaTRUE METRIX AIR Meter Only/REA4081-40, Centerwell TRUE METRIX AIR Starter Kit/REA4081-43, Healthmart TRUE METRIX AIR Kit/REA4089-01, Relion TRUE METRIX AIR Kit/REA4094-01, Relion TRUE METRIX AIR Kit/REA4094-01RX, Kroger TRUE METRIX AIR Kit/REA4203-01, Foster and Thrive TRUE METRIX AIR Kit/REA4211-01, TRUE METRIX AIR Kit/REA4H01-01, TRUE METRIX AIR NFRS Meter Only/REA4H01-40, TRUE METRIX AIR NFRS Starter Kit/REA4H01-43, TRUE METRIX AIR Kit (mg/dL)/REA4i03-01, TRUE METRIX AIR Starter Kit (mg/dL)/REA4i03-02, Walmart (MediMart) TRUE METRIX AIR Meter Only (Mexico - mg/dL)/REA4i04-00, TRUE METRIX AIR Kit (Australia - mmol/L)/REA4i81-11, TRUE METRIX AIR Kit (United Kingdom - mmol/L)/REA4i82-11, TRUE METRIX AIR Starter Kit (United Kingdom - mmol/L)/REA4i82-12 — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing

Feb 6, 2026device recall174d agoBD KIESTRA LAB AUTOMATION device recall (Cls II)

BD Kiestra" ReadA; Catalog No.: 446948. — Reason: In certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this occurred, there was potential for delays in plate retrieval from the incubator while connectivity was restored. This issue was intermittent and did not affect test results, performance of the assay, or sample integrity. — Status: Ongoing

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Feb 6, 2026device recall174d agoDatascope Corp. device recall (Cls III)

Battery Charging Station; Model: 0998-00-0802; — Reason: The Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used to operate the IABP. Getinge has identified that a protruding screw in the left battery bay limits full insertion of certain batteries and prevents proper charging. The right bay of the Battery Charging Station is not affected by this issue. — Status: Ongoing

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Feb 6, 2026device recall174d agoTrividia Health, Inc. device recall (Cls I)

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX GO Kit/RF4001-01BK, CVS TRUE METRIX GO Kit/RF4007-01, Meijer TRUE METRIX GO Kit/RF4019-01, Fred's Phamarcy TRUE METRIX GO Kit/RF4023-01, HEB TRUE METRIX GO Kit/RF4031-01, Hyvee TRUE METRIX GO Kit/RF4048-01, Rite Aid TRUE METRIX GO Kit/RF4066-01, TopCo TRUE METRIX GO Kit/RF4209-01, TRUE METRIX GO Kit/RF4H01-01BK, TRUE METRIX GO NFRS Meter Only/RF4H01-40, TRUE METRIX GO Kit (Jamaica - mmol/L)/RF4i29-11BK, TRUE METRIX GO Kit (Australia - mmol/L)/RF4i81-11BK, TRUE METRIX GO Kit (United Kingdom - mmol/L)/RF4i82-11BK, TRUE METRIX GO Starter Kit (United Kingdom - mmol/L)/RF4i82-12BK — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing

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Feb 6, 2026device recall174d agoHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha device recall (Cls II)

Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR — Reason: Software anomaly in the patient positioning system may result in positional discrepancy. — Status: Ongoing

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Feb 6, 2026device recall174d agoInternational Life Sciences device recall (Cls II)

Artelon FLEXBAND TWIST .12 Ref: TW012 3.85x17mm HEX Anchor (Qty 2) 5.0x17mm HEX Anchor (Qty 1) 0.5x12cm FLEXBAND (Qty 1) — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing

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Feb 6, 2026device recall174d agoInternational Life Sciences device recall (Cls II)

Artelon FlexBand Plus Ref: 41054 & 41057 — Reason: Augmentation devices failed bacterial endotoxin testing. — Status: Ongoing

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Feb 6, 2026device recall174d agoTrividia Health, Inc. device recall (Cls I)HENRY SCHEIN INC

Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRUE METRIX Kit/RE4001-01, Leader TRUE METRIX Kit/RE4002-01, Leader TRUE METRIX Meter Only/RE4002-40, CVS TRUE METRIX Kit/RE4007-01SB, GNP TRUE METRIX Meter Only/RE4011-00, GNP TRUE METRIX Kit /RE4011-01, MEIJER TRUE METRIX Kit/RE4019-01, FRED'S TRUE METRIX Kit/RE4023-01, DISCOUNT DRUG TRUE METRIX Kit/RE4025-01, KINRAY TRUE METRIX Kit/RE4027-01, HEB TRUE METRIX Kit/RE4031-01, McKesson TRUE METRIX Starter Kit/RE4051-43, SUNMARK TRUE METRIX Meter Only/RE4054-00, SUNMARK TRUE METRIX Kit/RE4054-01, Signature Care TRUE METRIX Kit/RE4060-01, CareOne TRUE METRIX Kit/RE4061-01, RITE AID TRUE METRIX Kit/RE4066-01, Liberty TRUE METRIX Meter Only/RE4078-40, HUMANA TRUE METRIX Starter Kit/RE4081-03, Wegmans TRUE METRIX Kit/RE4087-01, HEALTHMART TRUE METRIX Meter Only/RE4089-00, HEALTHMART TRUE METRIX Kit/RE4089-01, ARRIVA TRUE METRIX Meter Only/RE4095-40, HealthyAccents TRUE METRIX Kit/RE4097-01, Shopko TRUE METRIX Kit/RE4098-01, Henry Schein TRUE METRIX Kit/RE4099-40, Henry Schein TRUE METRIX Meter Only/RE4099-45, Millennium Pharmay Services TRUE METRIX Kit/RE4202-43, Kroger TRUE METRIX Kit/RE4203-01, TOPCARE TRUE METRIX Kit/RE4209-01, Foster and Thrive TRUE METRIX Kit/RE4211-01, TRUE METRIX Meter Only/RE4H01-00, TRUE METRIX Kit/RE4H01-01, TRUE METRIX Starter Kit/RE4H01-04, TRUE METRIX NFRS Meter Only/RE4H01-40, TRUE METRIX NFRS Starter Kit/RE4H01-43, TRUE METRIX Kit/RE4H01-51, TRUE METRIX Meter Only (mg/dL)/RE4i01-00, TRUE METRIX Kit (mg/dL)/RE4i01-01, TRUE METRIX Kit (mg/dL)/RE4i01-02, TRUE METRIX Starter Kit (mg/dL)/RE4i03-02, TRUE METRIX Kit (mmol/L)/RE4i03-11, Farmacia Benavides TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i05-00, Farmacia del Ahorro TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i07-00, TRUE METRIX Meter Only (Mexico - mg/dL)/RE4i23-00, TRUE METRIX Meter Only (Jamaica - mmol/L)/RE4i29-11, TRUE METRIX Kit (mg/dL)/RE4i61-02, TRUE METRIX Kit (mg/dL)/RE4i61-02THI, TRUE METRIX Kit (United Kingdom - mmol/L)/RE4i82-11, TRUE METRIX Starter Kit (United Kingdom - mmol/L)/RE4i82-12. — Reason: The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code description and recommended actions for the E-5 error code in the labeling do not: (a) clearly emphasize that an E-5 error code could represent a very high blood glucose level, and (b) prominently convey the appropriate immediate actions, such as contacting a healthcare professional. This could lead to a delay in treatment if the user does not seek medical attention immediately when receiving an E-5 error code and experiencing symptoms of high glucose. — Status: Ongoing

Feb 6, 2026device recall174d agoHitachi, Ltd. Radiation Oncology Systems, Kashiwanoha device recall (Cls II)

Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR — Reason: Software anomaly in the patient positioning system may result in positional discrepancy. — Status: Ongoing

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Week of Feb 9, 2026

30

Feb 9, 2026device recall171d agoReflexion Medical, Inc. device recall (Cls II)

RefleXion X1 Radiotherapy System Model RXM1000, Part #800-00006-00 — Reason: Due to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll corrections applied in the initial localization scan are not carried through to treatment delivery leading to the treatment plan dose being delivered to the incorrect location, potentially a displacement of 5mm or higher, with a 10% to 20% underdose. — Status: Ongoing

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Feb 9, 2026

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