The Recall Desk

State

Maine product recalls

72,936 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total
3,894
Critical
468
Severe
791
Most recent
2026-09-02

Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,936 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

3201–3225 of 76830

  • HighFDA (Devices)·Z-1347-2026·2026-02-18

    Azurion 7 B20 systems recalled over tables that may move unexpectedly

    Philips is recalling 1 of the Azurion 7 B20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 B20 System Model Numbers: (1)722068, (2)722226, (3)722236; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1349-2026·2026-02-18

    Azurion 7 M20 systems recalled over tables that may move unexpectedly

    Philips is recalling 5 of the Azurion 7 M20 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 M20 System Model Numbers: (1)722079, (2)722224, (3)722234, (4)722282(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0328-2026·2026-02-18

    Testosterone 100mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 4,599 pellets of Testosterone 100mg, Triamcinolone Acetonide 20mcg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 100mg, Triamcinolone Acetonide 20mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC:79559-6100-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1350-2026·2026-02-18

    Azurion 5 M12 systems recalled over tables that may move unexpectedly

    Philips is recalling 326 units of the Azurion 5 M12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 5 M12 System Model Numbers: (1)722227, (2)722231; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1346-2026·2026-02-18

    Azurion 7 B12 systems recalled over tables that may move unexpectedly

    Philips is recalling 655 units of the Azurion 7 B12 because the table may move unexpectedly when the Reset Geometry button is pressed, even with a table lock active.

    Product
    Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0322-2026·2026-02-18

    Testosterone 87.5mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 62,581 pellets of Testosterone, 87.5 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 87.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1087-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2026·2026-02-18

    Vancomycin 2 gram bags recalled over a lack of assurance of sterility

    Fresenius Kabi Compounding is recalling vancomycin HCl 2 grams in 500 mL sodium chloride injection over a lack of assurance of sterility.

    Product
    vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0318-2026·2026-02-18

    Testosterone 25mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 89,074 pellets of Testosterone, 25.0 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 25.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1025-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1340-2026·2026-02-18

    GammaPlan software recalled over plans that may irradiate the wrong location

    Elekta is recalling Leksell GammaPlan versions 11.3 and 11.4 because an error when defining a new stereotactic reference may produce a treatment plan that irradiates the incorrect patient location.

    Product
    Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11,3, 11.4 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0317-2026·2026-02-18

    Testosterone 18mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 146 pellets of Testosterone, 18.0 mg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1318-2026·2026-02-18

    Spectral CT 7500 scanners recalled over rotor fasteners that may loosen

    Philips is recalling 3 units of the Spectral CT 7500 on Rails because fasteners attaching the rotor to the gantry bearing may not be torqued to specification.

    Product
    Spectral CT 7500 on Rails; Product Code (REF): 728334;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1329-2026·2026-02-18

    Port and line access kits recalled over open swabstick applicator seals

    Medline is recalling 7,570 kits of convenience kits containing BD ChloraPrep Triple Swabsticks, which BD determined may exhibit an open seal on the applicator packaging.

    Product
    Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0329-2026·2026-02-18

    Testosterone 200mg pellets recalled over potential metal particulate matter

    Asteria Health is recalling 7,840 pellets of Testosterone 200mg, Triamcinolone Acetonide 40mcg sterile pellets over the potential presence of metal particulate matter.

    Product
    Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0340-2026·2026-02-18

    Cetrorelix injection kits recalled over missing or duplicated needles inside

    Meitheal Pharmaceuticals is recalling 16,477 Cetrorelix Acetate for Injection kits over a defective delivery system, with needles either missing from or duplicated within the kit.

    Product
    CETRORELIX ACETATE — CETRORELIX ACETATE (CETRORELIX ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1342-2026·2026-02-18

    Navigation osteotomes recalled over incorrect array connection geometry

    Alphatec Spine is recalling 7 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1343-2026·2026-02-18

    Spinal navigation instruments recalled over incorrect array connection geometry

    Alphatec Spine is recalling 15 ATEC Lateral Navigation Disc Prep Instruments due to a design issue where the navigated array connection geometry is incorrect.

    Product
    ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 267-01-000-10-N UDI-DI code: 00190376541471; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1361-2026·2026-02-18

    Display adapters recalled after the wrong configuration file was used

    Steris is recalling 10 units of the Barco MNA with HexaVue IP Integration System because the supplier used the incorrect configuration file for a limited batch of adapter components.

    Product
    Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1341-2026·2026-02-18

    Compact suction units recalled over electromagnetic noise above aviation limits

    Laerdal Medical is recalling 1,202 Compact Suction Unit 4 RTCA units because those made in a limited period may emit electromagnetic noise beyond the acceptable RTCA limits.

    Product
    Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1360-2026·2026-02-18

    Extra large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Extra Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Extra Large REF: SP-163-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1358-2026·2026-02-18

    Newborn monitor caps recalled over an incorrect sizing guide on labeling

    SurePulse Medical is recalling the Surepulse VS Cap Medium because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Medium REF: SP-161-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1357-2026·2026-02-18

    Small newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Small because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Small REF: SP-160-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1359-2026·2026-02-18

    Large newborn monitor caps recalled over an incorrect sizing guide

    SurePulse Medical is recalling the Surepulse VS Cap Large because the labeling contains an incorrect sizing guide for the cap.

    Product
    Surepulse VS Cap Large REF: SP-162-A1 component of VS Newborn Heart Rate Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide