The Recall Desk

State

North Dakota product recalls

72,940 recalls have nationwide distribution and so reach North Dakota. 2,921 additional recalls listed North Dakota specifically in their distribution scope.

What the numbers show

Total
2,921
Critical
265
Severe
727
Most recent
2026-09-02

Of the 2,921 recalls naming North Dakota we have scored against our rubric, 265 (9%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 727 (25%) are Severe.

These figures cover only the 2,921 recalls whose distribution notice names North Dakota specifically. The 72,940 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

4201–4225 of 75861

  • HighFDA (Devices)·Z-0541-2026·2025-11-26

    Flow cytometers recalled over software that crashes during sample acquisition

    Beckman Coulter is recalling 25 DxFLEX Flow Cytometers because a software error crashes the system during acquisition on a patient sample when running a customer defined protocol.

    Product
    DxFLEX Flow Cytometer Catalog Number C78500 UDI-DI code: 15099590754013 The DxFLEX Flow Cytometer is intended for use as an in vitro diagnostic device for immunophenotyping up to ten fluorescent detection channels using three lasers (488 nm, 638 nm and 405 nm) and two light s
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighCPSC·26114·2025-11-26

    Pressure mounted safety gates recalled over a torso sized opening

    About 100 Ikuso pressure-mounted safety gates are being recalled because a child's torso can fit through the opening between the gate slat and the side wall.

    Product
    Ikuso Safety Gates
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0518-2026·2025-11-26

    Port insertion packs recalled over smoke pencils that may stay live

    Medline is recalling 12 Port Insertion Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0503-2026·2025-11-26

    Oncology software recalled because appended medication orders may mismatch the schedule

    Elekta is recalling four systems running MOSAIQ Oncology Information System builds 3.1.3 through 3.2.3.0 because appended wave medication orders may not match the intended schedule.

    Product
    MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.2.3.0 Software Version and UDI Codes: 3.1.3.0 (01)07340201500026(10)3.1.3.0 3.1.3.1 (01)07340201500026(10)3.1.3.1 3.1.3.2 (01)07340201500026(10)3.1.3.2 3.1.3.3 (01)07340201500026(10)3.1.3.3 3.1.3
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0526-2026·2025-11-26

    Caesarean section kits recalled over smoke pencils that may activate

    Medline is recalling 11,032 C-section convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0529-2026·2025-11-26

    Minor eye trays recalled over smoke pencils that may stay active

    Medline is recalling 345 Minor Eye Tray #81 convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) MINOR EYE TRAY #81, REF DYNJ27466T.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0523-2026·2025-11-26

    Major vaginal surgery packs recalled over smoke pencil activation defect

    Medline is recalling 424 major vaginal surgery convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF DYNJ0161768G; 2) ACH MAJOR VAGINAL PACK, REF DYNJ67757B.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0504-2026·2025-11-26

    Luer tip caps recalled after trays failed routine biocompatibility testing

    Becton Dickinson is recalling 4,180,000 BD Luer Tip Caps after internal testing confirmed that certain device trays failed routine biocompatibility testing.

    Product
    BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0533-2026·2025-11-26

    Hemostasis valves recalled because the valve cap may remain depressed

    Merit Medical is recalling 217,141 PhD Hemostasis Valves because a manufacturing defect can leave the valve cap depressed, leading to potential leakage and possible hemorrhage.

    Product
    PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A, MAP800/B, MAP800/T, MAP801/B, MAP802/B, MAP802/CNB, MAP802/T, MAP804/B, MAP852/B, SKY1802.
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0540-2026·2025-11-26

    Bone void implants recalled over an incorrect product name on packaging

    Berkeley Advanced Biomaterials is recalling 62 Tribio Implants 7.5mm x 40mm because the outer packaging carries an incorrect product name.

    Product
    Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0524-2026·2025-11-26

    Gynecology and robotic kits recalled over smoke pencils that may self activate

    Medline is recalling 2,844 gynecology laparoscopy and robotic convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CDS920099S; 2) GYN LAPAROSCOPY CDS-LF, REF CDS983764J; 3) ROBOTIC, REF CDS984262N; 4) ROBOTIC, REF CDS984262P; 5) ROBOTIC UROLOGY-RF, REF DYNJ38844N; 6) DA VINCI PROSTATE/COLPOPEXY, REF DYNJ44864
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0542-2026·2025-11-26

    Cell morphology analyzers recalled over barcodes read from the previous slide

    Cellavision is recalling 688 DI-60 automated digital cell morphology analyzers because the barcode reader may read the previous slide's barcode, misattributing diagnostic results.

    Product
    REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, IVD in conjunction with a Honeywell Vuquest or Jadk FM-5 barcode reader component.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0514-2026·2025-11-26

    Central line and flap packs recalled over smoke pencils that may activate

    Medline is recalling 142 central line and free flap convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2) FREE FLAP PACK, REF DYNJ68213C.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0528-2026·2025-11-26

    LEEP procedure packs recalled over smoke pencils that may self activate

    Medline is recalling 18 GP-LEEP convenience packs containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0506-2026·2025-11-26

    Heart pump controllers recalled over corrosion at the backup battery connector

    Thoratec is recalling 35,376 HeartMate 3 Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Model/Catalog Number: 106531US, HeartMate 3 Controller, US; 106531INT, HeartMate 3 Controller, OUS; 106531LF2, HeartMate 3 Low Flow 2.0 Controller Software Version: N/A Product Description: The HeartMate
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0513-2026·2025-11-26

    Vascular and open heart kits recalled over smoke pencils that may activate

    Medline is recalling 5,133 vascular, carotid and open heart convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261AB; 2) CAROTID ENDARTERECTOMY CDS-LF, REF CDS983637I; 3) PERIPHERAL VASCULAR CDS, REF CDS983723J; 4) ACH OPEN HEART, REF CDS983773J; 5) VASCULAR, REF CDS984255K; 6) OPEN HEART CHILDRENS PACK-LF,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0521-2026·2025-11-26

    General surgery and knee kits recalled over smoke pencil activation defect

    Medline is recalling 20,941 general surgery, laparoscopy and total knee convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJO
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0505-2026·2025-11-26

    Heart pump kits recalled over corrosion at the backup battery connector

    Thoratec is recalling 29,059 HeartMate 3 Left Ventricular System kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVAS) Kits Model/Catalog Number: 106524US, HeartMate 3 LVAS KIT, US; 106524INT, HeartMate 3 LVAD KIT, OUS; 106524 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0509-2026·2025-11-26

    ECMO consoles recalled after eleven reports of a blank touchscreen error

    Medtronic is recalling 167 MC3 VitalFlow Consoles after eleven reports of an E70 error code that leaves the touchscreen blank for up to two minutes during operation.

    Product
    MC3 VitalFlow Console, REF 58100; Blood pump of ecmo
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0525-2026·2025-11-26

    Circumcision packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 120 Circumcision Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0519-2026·2025-11-26

    Breast and plastics packs recalled over smoke pencils that may activate

    Medline is recalling 4,214 breast, abdominoplasty and plastics convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF DYNJ00264M; 4) BREAST ABDOMINOPLASTY MZ PK-LF, REF DYNJ0428947L; 5) BREAST ABDOMINOPLASTY MB PK-LF, REF DYNJ0428947M; 6) AUGMENTATION #
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0507-2026·2025-11-26

    Heart pump implant kits recalled over corrosion at the battery connector

    Thoratec is recalling 248 HeartMate II LVAS Implant Kits because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Catalog Number: 106015, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, US; 106016, HeartMate II¿ LVAS Kit, with Pocket Controller, Sealed, EU Software Version: N/A Product Description: The Heart
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0511-2026·2025-11-26

    Local basic kits recalled over smoke pencils that may stay active

    Medline is recalling 48 LOCAL BASIC convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0512-2026·2025-11-26

    Pacemaker packs recalled over smoke pencils that can remain active

    Medline is recalling 12 Cath Lab Pacemaker Pack convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall of the pencils by 47 lots.

    Product
    MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A
    Category
    Medical Device
    Distribution
    Distributed nationwide