The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

2801–2825 of 52938

  • HighNHTSA·25V825000·2025-12-01

    KTM and Husqvarna motorcycles recalled for engine control software stalling defect

    KTM and Husqvarna are recalling certain 2024-2025 motorcycles because faulty engine control software may cause the engine to stall at low RPMs, creating a risk of crashes.

    Product
    KTM — KTM, HUSQVARNA 390 SMC R, 390 ENDURO R, 390 ADVENTURE X, VITPILEN 401
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V823000·2025-12-01

    2025 Ford Expedition and Other Models Recalled for Brake Booster Malfunction

    Ford is recalling 679 2025 Expedition, Ranger, F-150, Bronco, and Navigator vehicles due to a potential Electronic Brake Booster malfunction that can cause loss of power brake assist, increasing crash risk.

    Product
    FORD — FORD, LINCOLN F-150, EXPEDITION, BRONCO, RANGER
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V826000·2025-12-01

    2025-2026 RAM Pickup Trucks: Blank Instrument Panel Display Software Error

    Chrysler is recalling 2025-2026 RAM pickup trucks (1500, 2500, 3500, 4500, 5500) because a software error causes the instrument panel display to go blank, preventing drivers from seeing critical warning lights and gear selection.

    Product
    RAM — RAM 1500, 2500, 3500, 4500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·25V831000·2025-12-01

    2025 Lincoln Navigator Rear Lightbar Cracks May Disable Reverse Lights

    Ford is recalling certain 2025 Lincoln Navigator vehicles. The rear lightbar may develop cracks allowing moisture accumulation, potentially disabling reverse lights and reducing visibility when backing up.

    Product
    LINCOLN — LINCOLN NAVIGATOR
    Category
    Vehicle
    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-0527-2026·2025-11-26

    Gynecology surgery kits recalled over smoke pencils that may activate

    Medline is recalling 570 gynecology laparotomy, lithotomy and hysterectomy convenience kits containing SafeAir Smoke Evacuation Pencils, after Stryker expanded its recall by 47 lots.

    Product
    MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF DYNJ0160684F; 2) MAJOR LITHOTOMY PACK-LF, REF DYNJ0425778O; 3) MINOR VAGINAL #76-RF, REF DYNJ27434R; 4) ABDOMINAL HYST PACK, REF DYNJ44848M; 5) DA VINCI HYSTERECTOMY, REF DYNJ44863Q; 6) VAGINA
    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-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
  • 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-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-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-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-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-0508-2026·2025-11-26

    HeartMate II controllers recalled over corrosion at the battery connector

    Thoratec is recalling 2,424 HeartMate II Pocket Controllers because potential corrosion at the backup battery cable connector may cause a Backup Battery Fault Alarm.

    Product
    Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) Model/Catalog Number: 106017, HeartMate II¿ Pocket Controller, US; 106762, HeartMate II¿ Pocket Controller, US; 107801, HeartMate II¿ Pocket Controller Software Version: N/A Product Description: The Hea
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V821000·2025-11-26

    2025 Nissan Murano vehicles recalled for rearview camera display software fault

    Nissan is recalling certain 2025 Murano and 2025–2026 Armada vehicles, along with 2025–2026 Infiniti QX80 models, due to a software error that may prevent the rearview camera from displaying when the vehicle is in reverse, reducing visibility and increasing crash risk.

    Product
    NISSAN — NISSAN, INFINITI ARMADA, QX80, MURANO
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0515-2026·2025-11-26

    Breast biopsy packs recalled over smoke pencils that may activate

    Medline is recalling 301 breast biopsy and mastectomy 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) BREAST BIOPSY PACK-LF, REF DYNJ0160598C; 2) BIOPSY BREAST PACK, REF DYNJ65361A; 3) BREAST BIOPSY/MASTECTOMY, REF DYNJ908839A.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0573-2026·2025-11-26

    Non Siemens imaging catheters recalled after exceeding validated reprocessing cycles

    Sterilmed is recalling six reprocessed ACUSON AcuNav diagnostic ultrasound catheters, the variant not for use with Siemens systems, because they were reprocessed beyond validated cycles.

    Product
    Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Product Name: CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WITH SIEMENS SYSTEM Model/Catalog Number: ACU10135910 Software Version: N/A Product Description: ACUSON, CATHETER
    Category
    Medical Device
    Distribution
    8 states
  • 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-0520-2026·2025-11-26

    Basin packs recalled over smoke pencils that may activate unprompted

    Medline is recalling 1,921 basin 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) MINOR SINGLE BASIN PACK, REF DYNJ37698L; 2) BASIN PACK, REF DYNJ50123D; 3) MAJOR BASIN PACK, REF DYNJ59816A; 4) OSC BASIN PACK, REF DYNJ68217A.
    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