The Recall Desk

State

Maine product recalls

73,576 recalls have nationwide distribution and so reach Maine. 3,922 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,922
Critical
478
Severe
964
Most recent
2026-09-23

Of the 3,922 recalls naming Maine we have scored against our rubric, 478 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 964 (25%) are Severe.

Which agencies issued them

These figures cover only the 3,922 recalls whose distribution notice names Maine specifically. The 73,576 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

576–600 of 77498

  • HighFDA (Devices)·Z-3197-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components manufactured with aged polyethylene material that may oxidize and increase wear.

    Product
    ALL POLY CONSTRAINED INSERT 54MM 69-2854 NRG KNEE CR 82-2-0512 82-2-0518 82-2-0912 NRG KNEE P/S 82-3-0318 SCORPIO + MOBILE BEARING PCS 78-5-0910 SCORPIO C-DOME PATELLA 73-2710 SCORPIO INSET PATELLA 73-2610 SCORPIO M-DOME PATELLA…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3169-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Server V7 Due to Data Association Error

    GE Healthcare is recalling 116 Centricity PACS Server V7 systems because historical imaging data may be incorrectly associated with the wrong patient, potentially leading to misdiagnosis.

    Product
    Centricity PACS Server V7, intended for managing digital medical images and associated data, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3185-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B12LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 12X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3202-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implant Components Due to Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made from aged polyethylene. The material may oxidize and wear excessively, potentially causing device failure.

    Product
    BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640 DIA STEM C-M113-5-600 SELF-PRESSURIZING GLENOID SIZE 9 C-M063-5-800 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3168-2026·2026-09-23

    GE Healthcare Recalls Centricity PACS Software Due to Data Association Errors

    GE Healthcare is recalling Centricity PACS software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity PACS V2, V3, V4, V6, V7, software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices, All versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3166-2026·2026-09-23

    GE Healthcare Recalls Centricity Enterprise Archive Software Due to Data Association Errors

    GE Healthcare is recalling Centricity Enterprise Archive software because historical imaging data may be incorrectly associated with different patients, potentially leading to misdiagnosis or delayed care.

    Product
    Centricity Enterprise Archive V2, V3, and V4, software product for receiving, archiving, and sending electronic medical data, All Versions
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3205-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Polyethylene Material Aging

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components because aged polyethylene material may cause increased wear and device failure.

    Product
    SCORPIO + MOBILE BEARING PCS 78-5-0910 SYSTEM ONE BIPOLAR 40MM 6074-4022 SYSTEM ONE BIPOLAR 43MM 6074-4322 SYSTEM ONE BIPOLAR 44MM 6074-4422 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3141-2026·2026-09-23

    Philips Patient Information Center iX Software Malfunction Recall

    Philips North America is recalling 7,359 Patient Information Center iX units due to a software malfunction that may cause the system to freeze and become unresponsive.

    Product
    Philips Patient Information Center iX REF:866389
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3145-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet is recalling Percutaneous Insertion Kits because the packaging may not consistently maintain sterile barrier integrity.

    Product
    Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3178-2026·2026-09-23

    restor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides

    restor3d Inc. is recalling two Kinos Axiom Total Ankle Systems because they were packaged with incorrect patient-specific cutting guides, which may lead to surgical complications.

    Product
    Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3209-2026·2026-09-23

    Medline Myringotomy Kits Recalled for Potential Sterility Compromise

    Medline Industries is recalling 60 Myringotomy Pack-LF kits due to open seals that may compromise sterility and lead to patient infection.

    Product
    Convenience kits MYRINGOTOMY PACK-LF DYNJ59097A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3199-2026·2026-09-23

    Howmedica Recalls Orthopaedic Implants Due to Aged Polyethylene Material

    Howmedica Osteonics Corp. is recalling specific orthopaedic implant components made with aged UHMWPE material. The material may oxidize, leading to increased wear, device fracture, or the need for revision surgery.

    Product
    ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR INSERT 48/50/52mm OD x 28mm ID C-M071-6-700 ARC2F ACETABULAR INSERT 50mm OD x 28mm ID 10DEGREE HOOD C-M071-8-400 BEARING AND AXLE BUSHING ASSY STANDARD ELBOW…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3203-2026·2026-09-23

    Howmedica Recalls Scorpio Receded Metal Backed Patella Implants

    Howmedica Osteonics Corp. is recalling specific Scorpio knee implant components due to aged polyethylene material that may cause increased wear and potential device failure.

    Product
    SCORPIO RECESSED METAL BACKED PATELLA 3045-0026 3045-0028 3045-0030 3045-0032 Orthopaedic implant components manufactured from UHMWPE (polyethylene)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3165-2026·2026-09-23

    NOxBOXi Nitric Oxide Delivery System Recalled for Tubing Leak Risk

    NOXBOX LTD is recalling 1,547 NOxBOXi Nitric Oxide Delivery Systems due to potential oxygen tubing leaks that may cause oxygen desaturation.

    Product
    NOxBOXi Nitric Oxide Delivery System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3187-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocars Due to Cracking Risk

    Stryker is recalling 9,072 XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3186-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3144-2026·2026-09-23

    Maquet Percutaneous Insertion Kit Recalled for Sterile Barrier Integrity Issues

    Maquet Cardiopulmonary GmbH is recalling Percutaneous Insertion Kits because packaging may not consistently maintain sterile barrier integrity.

    Product
    Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS);
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3183-2026·2026-09-23

    Stryker Recalls XCEL Bladeless Trocar Due to Cracking Risk

    Stryker is recalling XCEL Bladeless Trocars because the reusable access port system may crack or separate during use.

    Product
    REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEEVE 5MM X 75MM
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3190-2026·2026-09-23

    Datex-Ohmeda Aisys CS2 Anesthesia Systems Recalled for Gas Mixer Defect

    Datex-Ohmeda is recalling 140 Aisys CS2 anesthesia systems because electronic gas mixer assemblies may fail, interrupting anesthetic delivery and requiring clinician intervention.

    Product
    Aisys CS2, Datex-Ohmeda anesthesia system, Part Number 1011-9055-000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-3181-2026·2026-09-23

    Blood Culture Kits Recalled Due to Potential Sterile Barrier Compromise

    Medical Action Industries is recalling blood culture kits containing BD ChloraPrep applicators with potentially compromised sterile seals, posing a risk of localized skin infection.

    Product
    Blood Culture Collection Venipuncture Kit 20/Cs, REF: 77451; Blood Culture Kit 20/Cs, REF: 81834B; Blood Culture Collection Kit, REF: 81834C. All containing BD ChloraPrep Clear - 1 mL Applicators
    Category
    Medical Device
    Distribution
    Distributed nationwide