The Recall Desk

State

Maine product recalls

20,322 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.

12876–12900 of 20322

  • 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-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-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-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-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 (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-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-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-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-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-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 (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
  • 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
  • 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
  • HighCPSC·23223·2023-06-15

    Trek Bicycles with Promax Hydraulic Disc Brakes Recalled for Crash Hazard

    Trek Bicycle Corp. is recalling about 96,900 bicycles equipped with Promax hydraulic disc brakes because the brake hose can detach from the brake lever, posing a crash hazard. Trek has received 195 reports of this issue with no injuries reported.

    Product
    Promax hydraulic disc brakes sold on Trek bicycles
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighCPSC·23222·2023-06-15

    Oceanic SCUBA Buoyancy Compensating Devices Recalled for Drowning Hazard

    Huish Outdoors is recalling Oceanic brand SCUBA diving buoyancy compensating devices because the weight pocket handle can break during use, preventing divers from dumping weight in an emergency to surface safely. No injuries have been reported, but 73 broken handles have been documented.

    Product
    SCUBA Diving Buoyancy Compensating Devices OceanPro, Excursion, Hera
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • CriticalFDA (Devices)·Z-1650-2023·2023-06-14

    Philips Trilogy and LifeVent ventilator models recalled for flow sensor debris

    Environmental debris accumulation may block flow sensors in Philips ventilators, potentially preventing accurate pressure and flow delivery to patients.

    Product
    Trilogy Evo O2 and LifeVent EVO2, Model Numbers DS2100X11B, IN2100X15B, IN2100X19, FX2100X15B, LA2100X15B, IA2100X15B, FP2100X10, FR2100X14B, ND2100X15B, IT2100X21B, ES2100X15B, DE2100X13B, EU2100X15B, EU2100X19, EE2100X15B, and SP2100X26B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1651-2023·2023-06-14

    Trilogy Evo O2 EV300 respiratory devices recalled for debris accumulation

    Philips Respironics recalled 18,855 Trilogy Evo O2 EV300 devices because environmental debris may accumulate on the flow sensor, potentially causing inaccurate delivery of pressure or flow. This could result in patient hypoxemia if not promptly addressed.

    Product
    Trilogy Evo O2 EV300, Model Numbers DS2200X11B, IN2200X15B, FX2200X15B, CA2200X12B, FR2200X14B, ND2200X15B, ES2200X15B, BL2200X15B, GB2200X15B, EU2200X15B, EE2200X15B, and TR2200X15B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1652-2023·2023-06-14

    Trilogy Evo Universal Ventilator Class I Recall—22,237 Units Affected

    The FDA has issued a Class I recall for the Trilogy Evo Universal Ventilator Model DS2000X11B, affecting 22,237 units distributed nationwide and globally. The device is manufactured by Philips Respironics, Inc.

    Product
    Trilogy Evo Universal Ventilator, Model Number DS2000X11B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1649-2023·2023-06-14

    Philips Respironics Ventilators Recalled for Flow Sensor Debris Accumulation

    Philips Respironics recalled approximately 57,395 ventilators due to environmental debris potentially accumulating on the flow sensor, which may prevent accurate delivery of pressure and volume to patients, risking hypoxemia.

    Product
    Trilogy Evo, Garbin Evo, and Aeris EVO, Model Numbers DS2110X11B, IN2110X15B, JP2110X16B, AU2110X15B, LA2110X15B, CA2110X12B, BR2110X18B, KR2110X15B, IA2110X15B, FP2110X10, FR2110X14B, ND2110X15B, IT2110X21B, ES2110X15B, DE2110X13B, BL2110X15B, GB2110X15B, EU2110X15B, EE2110X15B,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1633-2023·2023-06-14

    FDA Recalls Walnut Wearable Smart Thermometer Due to Reported Skin Burns

    BearCare's Walnut Wearable Smart Thermometer (Model WT20) is being recalled due to reports of skin burns in children ages 0-6. The device was distributed nationwide; 1818 units were affected.

    Product
    Walnut Wearable Smart Thermometer, intended for continuous chest temperature monitoring of children ages 0-6 years in non-emergency medical situations, Model Number WT20
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1630-2023·2023-06-14

    StealthStation Cranial Software Depth Gauge Synchronization Failure Risk

    A software anomaly in StealthStation Cranial Software causes depth gauge displays to lose synchronization during cranial biopsy procedures, risking inaccurate surgical guidance and tissue injury.

    Product
    StealthStation Cranial Software, Models: 9735585, 9735586 (kit), 9735587 (kit), used with StealthStation S7/i7 systems
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1683-2023·2023-06-14

    QIAstat-Dx Respiratory SARS-CoV-2 Test Kit Recalled for False Result Risk

    Qiagen Sciences LLC recalls 347 QIAstat-Dx Respiratory SARS-CoV-2 test kits due to faulty cartridges that could produce false results. Affected kits were distributed nationwide in nine states.

    Product
    QIAstat-Dx Respiratory SARS-CoV-2 Panel multiplexed nucleic acid real-time PCR test, Reference Number 691223
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1687-2023·2023-06-14

    Avanos Medical Recalls ambIT Reusable Cassettes Missing Air-Inline Filter

    Avanos Medical is recalling SMMT ambIT Reusable cassettes (Product Code 220568, Lot 30191805) that were potentially distributed without a required air-in-line filter. The missing component affects units in Texas, Oregon, and Australia.

    Product
    SMMT ambIT Reusable Program - Luer Cass, Product Code: 220568
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1680-2023·2023-06-14

    DePuy Mitek surgical anchor inserter may fracture during use

    DePuy Mitek BIOKNOTLESS Rapid surgical anchor inserters may fracture during use, potentially retaining fragments in patients. Removal during surgery may cause bone damage and extended surgical time.

    Product
    DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in association with adequate postoperative immobilization Model Number: 212722
    Category
    Medical Device
    Distribution
    Distributed nationwide