The Recall Desk

State

Massachusetts product recalls

73,190 recalls have nationwide distribution and so reach Massachusetts. 8,240 additional recalls listed Massachusetts specifically in their distribution scope.

What the numbers show

Total
8,240
Critical
1,181
Severe
2,025
Most recent
2026-09-30

Of the 8,240 recalls naming Massachusetts we have scored against our rubric, 1,181 (14%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,025 (25%) are Severe.

These figures cover only the 8,240 recalls whose distribution notice names Massachusetts specifically. The 73,190 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13901–13925 of 81430

  • HighFDA (Devices)·Z-0691-2024·2024-01-17

    VISERA Cysto-Nephro Videoscope Model CYF-V2: Reusable Brush Cleaning Update

    Olympus is updating instructions for the VISERA Cysto-Nephro Videoscope (Model CYF-V2) nationwide, removing reusable brushes from manual cleaning procedures. Single-use brushes remain compatible.

    Product
    Model No. CYF-V2, VISERA Cysto-Nephro Videoscope
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0643-2024·2024-01-17

    Bard Mission Biopsy Instrument Kits Recalled for Improper Needle-Cannula Fit

    Bard is recalling Mission Disposable Core Biopsy Instrument Kits due to dimensional issues that may prevent the biopsy needle from fitting properly into the cannula, potentially causing tissue injury and prolonging procedures.

    Product
    Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM; 1416MSK/ Mission Kit 14G x 16CM; 1610MSK/ Mission Kit 16G x 10CM; 1616MSK/ Mission Kit 16G x 16CM; 1810MSK/ Mission Kit 18G x 10CM; 1816MSK/ Mission Kit 18G x 16CM; 1820MSK/ Mission…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0672-2024·2024-01-17

    SPRYSTEP VECTOR KAFO ankle-foot orthosis recalled for structural failure risk

    The SPRYSTEP VECTOR KAFO custom ankle-foot orthosis is being recalled by Townsend Design due to air pockets that could cause complete structural failure.

    Product
    SPRYSTEP VECTOR KAFO, Custom made device dynamic ankle-foot orthosis (KAFO) non locking, REF #s: 17VKCUS and 17VKCUSX
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0714-2024·2024-01-17

    Ambu aView 2 Monitor recalled for fire and burn hazard from oversized mounting screws

    Ambu is recalling the aView 2 A Monitor due to fire and burn hazards if mounting screws longer than 16mm are used. Improper installation can penetrate the lithium-ion battery, causing fires, severe burns, and smoke inhalation.

    Product
    Ambu aView 2 A Monitor, Catalog numbers 405011000 and 405011000US2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0697-2024·2024-01-17

    Olympus ENDOEYE HD II Videoscope Image Discoloration Recall

    Two Olympus ENDOEYE HD II Rigid Videoscope catalog numbers (WA50040A, WA50042A) have been recalled due to reports of pink or green image discoloration during use. The issue could require device exchange during surgery and potentially result in visual impacts or bleeding.

    Product
    Olympus ENDOEYE HD II Rigid Videoscope Catalog Numbers: WA50040A, WA50042A -used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·24V018000·2024-01-17

    Heartland Recalls 2024 Corterra Fifth Wheels for Incorrect Tire Labels

    Heartland is recalling 2024 Corterra fifth wheels because certification labels may have missing or incorrect tire size information, potentially leading to the installation of wrong tires.

    Product
    HEARTLAND — HEARTLAND CORTERRA
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0698-2024·2024-01-17

    Medtronic Percutaneous Surgical Pins Recalled Due to Potential Fitting Defects

    Medtronic is recalling 4,235 percutaneous surgical pins that may have a manufacturing defect preventing proper fit into or removal from the tap cap. The pins were distributed nationwide and internationally.

    Product
    Medtronic, REF 9733235, Pin, 100mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0677-2024·2024-01-17

    Philips BrightView Gamma Camera System Recalled for Extremity Entrapment Hazard

    Philips is recalling BrightView Gamma Camera Systems because a gap can form between patient support and detector during quality assurance scans, creating an extremity entrapment hazard that may cause fractures or crush injuries.

    Product
    BrightView, Gamma Camera System, Product Code 882480.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0676-2024·2024-01-17

    BD Recanalization System May Overheat or Break During Use

    Bard Peripheral Vascular is recalling BD Recanalization Systems due to a manufacturing defect that may allow continuous operation without required safety warnings, increasing risk of device overheating or breaking during patient treatment.

    Product
    BD Recanalization System, REF: BDRECANSYSTEM
    Category
    Medical Device
    Distribution
    34 states
  • HighFDA (Devices)·Z-0640-2024·2024-01-17

    Philips Incisive CT Scanner Software Issues May Cause Misdiagnosis

    Philips is recalling Incisive CT scanners due to nine software defects including image artifacts, incorrect orientation labels, display failures, and positioning errors that could lead to misdiagnosis or need for rescans. No illnesses have been reported.

    Product
    Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0641-2024·2024-01-17

    Medical diagnostic reagent recall: incorrect cell staining fluorescence

    BD Biosciences is recalling CD11b APC diagnostic reagent vials that may produce dim fluorescence signals, potentially causing false negative results and misdiagnosis of blood cancers.

    Product
    CD11b APC: ASR, REF: 340936, and CE, REF: 333143
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0703-2024·2024-01-17

    Diagnostic Test Kits for GI Panel May Return False Negatives Due to Manufacturing Issue

    BioFire FILMARRAY GI Panel diagnostic test kits may return false negative results due to a manufacturing event, potentially leading to missed diagnoses and inappropriate treatment. The affected kits were distributed to locations in 16 U.S. states.

    Product
    BIOFIRE FILMARRAY Gastrointestinal (GI) Panel is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for use with BIOFIRE FILMARRAY Systems.
    Category
    Medical Device
    Distribution
    16 states
  • HighFDA (Devices)·Z-0644-2024·2024-01-17

    Olympus ENDOEYE Videoscope Recalled for Reprocessing Instructions Deviations

    Olympus Corporation recalls 1,403 ENDOEYE Flex endoscopic videoscopes due to deviations in reprocessing instructions. Affected devices may not be reprocessed properly for safe reuse in surgical procedures.

    Product
    OLYMPUS ENDOEYE FLEX DEFLECTABLE VIDEOSCOPE (5.4 mm diameter) Model: LTF-S190-5 Used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0652-2024·2024-01-17

    Abiomed Introducer Kit Sterile Barrier Compromise Due to Pouch Defect

    Abiomed Introducer Kits may have holes in outer pouches that compromise sterility, exposing patients to bacterial contamination and risk of infection, bacteremia, or sepsis.

    Product
    Abiomed Kit, 14Fr Introducer, 13cm&25cm, Sterile Part of Pump Set (0048-0040, 0048-0045, 1000080)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3046
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0646-2024·2024-01-17

    Medical Device Recall: Abiomed Axillary Insertion Introducer Sterile Barrier Breach

    Abiomed Axillary Insertion Introducer Kits have holes in the outer pouch that may compromise sterility, potentially exposing patients to serious infections including bacteremia and sepsis.

    Product
    Abiomed Axillary Insertion Introducer -Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 0052-3006 Individual, and Part of Pump Set (005062, 0550-0008, 1000100, 0052-0011, 1000220)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0682-2024·2024-01-17

    ARCHITECT c4000 Processing Module recalled for unlabeled latex component

    Abbott ARCHITECT c4000 Processing Module laboratory analyzers are recalled due to unlabeled dry natural rubber (latex) subcomponents. Individuals with latex allergies may experience allergic reactions if exposed to the undisclosed component.

    Product
    ARCHITECT c4000 Processing Module REF: 02P24-01 02P24-02 02P24-40 01R24-56 01R25-56 The Abbott ARCHITECT c4000 Processing Module is designed to perform automated chemistry tests, utilizing photometry and potentiometric technology.
    Category
    Medical Device
    Distribution
    48 states
  • HighFDA (Devices)·Z-0715-2024·2024-01-17

    MRI systems at risk of unintended magnet shutdown during power loss

    Philips Ingenia Ambition X and S MRI systems may experience uncontrolled shutdown of the sealed magnet if cryo-cooling is lost due to power outages. This could disrupt patient scans and operations.

    Product
    (1) Ingenia Ambition X (Product Number 781356); (2) Ingenia Ambition S (Product Number 781359)
    Category
    Medical Device
    Distribution
    24 states
  • HighFDA (Devices)·Z-0649-2024·2024-01-17

    Abiomed Introducer Kit recalled due to sterile barrier compromise risk

    Abiomed is recalling Introducer Kits (part 0052-3021) with holes in the outer pouch that compromise the sterile barrier, potentially exposing patients to infection. The kits were distributed nationwide and internationally.

    Product
    Abiomed Introducer Kit, 23 Fr, w/Hlx Vlv Sterile Individual, and Part of Pump Set (004334, 0046-0035, 0052-0002) Part Number: 0052-3021. Intended for introduction of the Impella Catheter into the body
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0223-2024·2024-01-17

    Tizanidine 4mg Tablets Recalled for Contamination with 2mg Tablets

    Dr. Reddy's Laboratories is recalling Tizanidine 4mg tablets due to the presence of 2mg tablets in bottles. About 38,952 bottles were distributed nationwide.

    Product
    TIZANIDINE — TIZANIDINE (TIZANIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0655-2024·2024-01-17

    Abiomed Introducer Kits Recalled for Sterile Barrier Pouch Defect

    Abiomed is recalling 84 introducer kits that may have holes in the outer pouch, compromising the sterile barrier. This exposes patients to microbial contamination and risk of serious infections including bacteremia and sepsis.

    Product
    Abiomed Kit, 23Fr Introducer, 11cm, Sterile Part of Pump Set (1000323)-Introducer(s) are intended for introduction of the Impella Catheter into the body. Part Number: 2000342
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0689-2024·2024-01-17

    Olympus Updates Manual Cleaning Instructions for Cysto-Nephro Videoscope

    Olympus has updated cleaning instructions for the Model CYF-VH Cysto-Nephro Videoscope. Reusable cleaning brushes are no longer recommended for manual cleaning; single-use brushes remain compatible.

    Product
    Model No. CYF-VH, CYSTO-NEPHRO VIDEOSCOPE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0673-2024·2024-01-17

    Boston Scientific ZOOM LATITUDE Pacemaker Programmer Software Displays Incorrect Diagnostic Dates

    Boston Scientific is recalling pacemaker programmer software that displays certain diagnostic dates incorrectly, with dates showing years in the 1990s. Affected diagnostic information may impact clinical monitoring.

    Product
    Boston Scientific Model 3120 ZOOM LATITUDE Programmer/Recorder/Monitor (PRM) installed with Model 2892 Programmer Application Software used for the following pacemaker products: ALTRUA 20, ALTRUA 40, ALTRUA 60, INSIGNIA I Entra, INSIGNIA I Plus, INSIGNIA I Ultra, NEXUS I Entra…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0678-2024·2024-01-17

    Gamma Camera Gap Creates Extremity Entrapment Hazard During Quality Assurance

    Philips BrightView X gamma cameras may create a gap between patient support and detector during quality assurance scans, potentially trapping a patient's extremity.

    Product
    BrightView X, Gamma Camera, Product Code 882478
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0699-2024·2024-01-17

    Medtronic Percutaneous Pins Recalled for Potential Fitting and Removal Issues

    Medtronic is recalling 4,224 REF 9733236 percutaneous pins due to a manufacturing defect that may prevent proper fitting or cause difficult removal. Affected devices were distributed worldwide.

    Product
    Medtronic, REF 9733236, Pin, 150mm, STERILE, PERCUTANEOUS
    Category
    Medical Device
    Distribution
    Distributed nationwide