The Recall Desk

State

Maine product recalls

20,308 recalls have nationwide distribution and so reach Maine. 0 additional recalls listed Maine specifically in their distribution scope.

About recalls in Maine

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Maine consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

12851–12875 of 20308

  • HighFDA (Devices)·Z-1972-2023·2023-06-21

    Driver Instrument May Break During Surgery, Leaving Metal Fragments

    The Superion Indirect Decompression System's driver instrument may fracture during implantation if excessive force is applied, potentially leaving metal fragments in the surgical site. Retained fragments contraindicate MRI scans.

    Product
    Driver Instrument, part of the Superion Indirect Decompression System, REF: 102-9800, used with the Superion Indirect Decompression System IFU, Superion IDS Kit IFU, Surgical Technique Manual
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1968-2023·2023-06-21

    Tearaway Introducer Kit Recalled Due to Potential Connector Defect

    Galt Medical Corporation is recalling Tearaway Introducer Kits due to potential cracking or dislodging of the luer connection during use, which can render the device unusable and require replacement.

    Product
    Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1917-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray May Have Non-Opening Valve

    Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly malfunction that could prevent fluid drainage.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1912-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled for valve assembly malfunction

    Merit Medical Systems is recalling the Aspira Pleural Drainage Catheter Insertion Tray because valve assemblies may not open, preventing proper fluid drainage.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992506, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1970-2023·2023-06-21

    SteriPack Sterile Polyester Spun Swabs recalled due to breakage risk

    LumiraDx recalled 1,003 kits of SteriPack Sterile Polyester Spun Swabs due to failed post-sterilization testing. Swabs may break in the nasal cavity, potentially causing injury or requiring medical intervention to remove fragments.

    Product
    SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1919-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray recalled due to valve malfunction

    Merit Medical Systems is recalling Aspira Drainage Catheter Insertion Tray 15.5F due to potential valve assembly failure that may prevent fluid drainage. No injuries reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0988-2023·2023-06-21

    Hu Vanilla Crunch Dark Chocolate recalled for undeclared tree nuts

    HU PRODUCTS is recalling Hu Vanilla Crunch Dark Chocolate bars nationwide because they may contain undeclared tree nuts, which pose a risk to consumers with tree-nut allergies.

    Product
    Hu Vanilla Crunch Dark Chocolate bar
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1824-2023·2023-06-21

    External Fixation System Post Component Recall Due to Thread Stripping

    New Standard Device Inc is recalling 222 units of 'n'-Hole Posts used in the Revolution External Fixation System because the threads strip out during tensioning, potentially compromising fracture fixation.

    Product
    'n'-Hole Post which is a component of the Revolution External Fixation System Catalog Numbers: 100801, 100802, 100803, 100804, 100805
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1908-2023·2023-06-21

    Aspira Peritoneal Drainage Catheter Insertion Tray Valve Malfunction Recall

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays due to a potential valve assembly malfunction that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1966-2023·2023-06-21

    bellavista 1000 Ventilator Recalled for Software Hang and Use Error Risk

    Vyaire Medical is recalling approximately 910 units of the bellavista 1000 Ventilator due to a software issue that can cause the touchscreen to become unresponsive and a potential use error risk if operators do not confirm settings are appropriate for the patient.

    Product
    bellavista 1000 Ventilator, Catalogue Number 301.100.030; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2023·2023-06-21

    Merit Medical Peritoneal Drainage Catheter Insertion Tray Recalled for Valve Failure

    Merit Medical Systems is recalling Aspira Peritoneal Drainage Catheter Insertion Trays because valve assemblies may fail to open, potentially preventing proper fluid drainage in affected lots.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992209 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2023·2023-06-21

    FDA Recalls Aspira Peritoneal Drainage Catheter Insertion Tray for Valve Failure

    Merit Medical Systems recalls Aspira Peritoneal Drainage Catheter Insertion Tray due to a potential valve failure that could prevent necessary fluid drainage.

    Product
    Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992207 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1969-2023·2023-06-21

    Tearaway Introducer Set Recall Due to Potential Luer Connection Failure

    Galt Medical Corporation is recalling Tearaway Introducer Sets due to potential cracks or dislodgement of the luer connection during use. The defect, linked to improper storage conditions, could render the device unusable.

    Product
    Tearaway Introducer Set, REF: INT-028-27, INT-105-25, INT-106-09, INT-106-12, INT-106-17, DSS-007-04, DSS-007-05, DSS-010-065, DSS-012-07 (bulk)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1693-2023·2023-06-21

    p-Chip Wand Reader Recalled for Laser Classification Safety Issue

    FDA is recalling 329 p-Chip Wand Reader units due to laser operation potentially exceeding its classified safety level. Affected models are WA-4000, WA-4500, WA-8000, and WA-8500 distributed nationwide.

    Product
    p-Chip Wand Reader
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1918-2023·2023-06-21

    Aspira Drainage Catheter Tray Recalled for Potential Valve Malfunction

    Merit Medical Systems recalls Aspira Drainage Catheter Insertion Trays due to potential valve assembly failure that may prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-11-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1703-2023·2023-06-21

    Medicine Dropper Recalled for Potential Glass Particulate Contamination

    Apothecary Products, LLC is recalling 1,596 units of Medicine Dropper (Lot 021623) due to potential glass particles on the dropper bulb exterior. Glass particles could contaminate medication or cause injury.

    Product
    Medicine Dropper, Product Code K508
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1915-2023·2023-06-21

    Aspira Pleural Drainage Catheter Insertion Tray recalled due to valve failure

    Merit Medical Systems recalls the Aspira Pleural Drainage Catheter Insertion Tray due to a potential valve failure that could prevent fluid drainage. The recall affects approximately 1054 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0872-2023·2023-06-21

    Hand Sanitizer Recalled Due to Manufacturing Deficiency and Methanol Risk

    Jarman's Midwest Cleaning Systems recalled 1,276 gallons of isopropyl alcohol hand sanitizer nationwide due to manufacturing deficiencies and potential methanol contamination risk found at the production site.

    Product
    Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS Midwest Cleaning Solutions, 404 Noid Rd., Canton, SD 57013. NDC: 74663-002-01
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1920-2023·2023-06-21

    Aspira Drainage Catheter Insertion Tray valve assembly may fail to open

    Merit Medical Systems is recalling certain Aspira Drainage Catheter Insertion Trays (Model 15.5F) due to a potential valve assembly defect that could prevent fluid drainage. No injuries have been reported.

    Product
    Aspira Drainage Catheter Insertion Tray 15.5F, REF: ASP-15-5, STERILE EO, Rx Only *EU Distribution only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1825-2023·2023-06-21

    Philips Tempus LS-Manual Defibrillator pacing failure due to communication error

    A communication failure in the Philips Tempus LS-Manual Defibrillator may prevent pacing delivery. The device displays an error message and potentially becomes ineffective, affecting approximately 1,147 units distributed nationwide.

    Product
    Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1916-2023·2023-06-21

    Aspira Valve Repair Kit may fail to open and obstruct fluid drainage

    Merit Medical Systems is recalling Aspira Valve Repair Kits because valve assemblies may fail to open, preventing fluid drainage. The FDA Class II recall affects 2,559 units distributed across the US and internationally.

    Product
    Aspira Valve Repair Kit, REF: 4992306 Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1967-2023·2023-06-21

    bellavista 1000e Ventilator Software May Hang, Affecting Device Interface

    Vyaire Medical is recalling certain bellavista 1000e ventilators due to software issues that may cause the touchscreen to become unresponsive. The recall also addresses potential operator error risks if ventilator settings are not confirmed before application.

    Product
    bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1914-2023·2023-06-21

    Aspira Pleural Drainage Catheter trays recalled for valve failure

    Merit Medical Systems recalls Aspira Pleural Drainage Catheter Insertion Trays because valve assemblies may not open, preventing fluid drainage. The recall affects 436 units distributed nationwide and internationally.

    Product
    Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF 4992508, Version A, Sterile EO, Rx Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0871-2023·2023-06-21

    Tranexamic Acid Tablets Recalled for Failed Manufacturing Specifications

    Amring Pharmaceuticals is recalling 48,989 bottles of Lysteda (tranexamic acid) USP 650 mg tablets due to failed manufacturing specifications for impurities and degradation. The affected lots did not meet conductivity specifications during quality testing.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0875-2023·2023-06-21

    Tranexamic Acid tablets recalled due to failed specification testing

    AVKARE LLC is recalling Tranexamic Acid USP 650mg tablets nationwide due to failed quality control specifications for conductivity. No illnesses have been reported.

    Product
    TRANEXAMIC ACID — TRANEXAMIC ACID (TRANEXAMIC ACID)
    Category
    Drug
    Distribution
    Distributed nationwide