The Recall Desk

State

Maine product recalls

72,986 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 72,986 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6476–6500 of 76880

  • ModerateFDA (Devices)·Z-1821-2025·2025-06-04

    Atellica IM Homocysteine Calibrator recalled for assay instability

    Siemens Healthcare Diagnostics is recalling certain lots of Atellica IM Homocysteine Calibrator because calibrator instability causes increased positive bias and does not meet the assay reference interval requirements.

    Product
    Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1876-2025·2025-06-04

    VITROS Chemistry Products CRP Slides Incorrectly Labeled Coating Generation

    Ortho-Clinical Diagnostics is recalling VITROS Chemistry Products CRP Slides because the product carton, foil wrapper, and cartridge label were incorrectly marked with "GEN 88" instead of the correct "GEN 83" designation.

    Product
    VITROS Chemistry Products CRP Slides. One sales unit contains 5 cartridges, of 18 slides per cartridge, for a total of 90 slides.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1830-2025·2025-06-04

    Abbott HbA1c Hemoglobin Afinion Test Kit Cold Chain Failure

    Abbott HbA1c Hemoglobin Afinion test kits are being recalled due to transit delays caused by severe thunderstorms that may have exposed products to storage temperatures outside the manufacturer's recommended range, potentially causing incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC HBA1C HEMOGLOBIN AFINION GLYCTD (15TST/BX) TEST KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1838-2025·2025-06-04

    HemoCue Inc Hemotrol Low Control affected by cold chain transit delays

    HemoCue Inc Hemotrol Low Level 1 control product was subject to transit delays during severe thunderstorms that may have caused storage outside recommended temperature conditions, potentially leading to incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL LOW 2X1ML LEVEL 1 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1862-2025·2025-06-04

    GM Helix Acqua Implant labeled 11.5 mm may contain 13 mm

    Straumann USA LLC is recalling GM Helix Acqua Implants (Article Number 140.984) because packages labeled as 11.5 mm implants may contain 13 mm implants instead.

    Product
    GM Helix Acqua Implant, Article Number: 140.984
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1858-2025·2025-06-04

    Catalyst+ Patient Positioning Software May Fail to Apply Rotation Correctly

    C-RAD POSITIONING AB has recalled Catalyst+ and related patient positioning devices due to a software issue where field rotation may not be applied correctly during scanning.

    Product
    Brand Name: Catalyst+ Product Name: C4D software used in conjunction with Catalyst (SP001-0025), Catalyst HD (SP001-0026), Catalyst PT (SP001-0027), Catalyst X4 (SP002-0035), Catalyst+ (SP003-0001), Catalyst+ HD (SP003-0002), Catalyst+ PT (SP003-0008), Cataly
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0452-2025·2025-06-04

    Theophylline Extended-Release Tablets recalled for dissolution test failure

    Glenmark Pharmaceuticals is recalling Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, due to out-of-specification results on dissolution testing. The recall affects 8,520 bottles distributed nationwide.

    Product
    THEOPHYLLINE — THEOPHYLLINE (THEOPHYLLINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1834-2025·2025-06-04

    Ortho Clinical Diagnostics Diluent Pack Recall Due to Cold Chain Failure

    McKesso Medical-Surgical Inc. is recalling Ortho Clinical Diagnostics FS Diluent Packs due to transit delays from severe thunderstorms that may have caused improper storage conditions. The affected products could produce incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC FS(3PK/BX)ORCLNL DILUENT PACK 3.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1854-2025·2025-06-04

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set Recall

    Sekisui Diagnostics LLC Serum HCG Osomgenzme Control Set units may have been exposed to improper storage conditions during transit due to severe thunderstorms, which could result in incorrect or delayed test results.

    Product
    SEKISUI DIAGNOSTICS LLC SERUM HCG OSOMGENZME CONTROL SET.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1828-2025·2025-06-04

    BD Microbiology Fluid Thioglycollate Medium Tubes Recall

    McKessan Medical-Surgical is recalling BD Microbiology Fluid Thioglycollate Medium tubes due to transit delays and severe thunderstorms that may have caused storage outside recommended conditions, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY FLUID THIOGLYCOLLATE MED TUBE 1004321196 (100/CT) MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1836-2025·2025-06-04

    Ortho Clinical Diagnostics Anti-B Bioclone diagnostic reagent recalled

    Ortho Clinical Diagnostics Anti-B Bioclone reagent is recalled due to cold-chain failures during transit caused by severe thunderstorms. Products may have been stored outside recommended conditions, potentially increasing the risk of incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC ANTI-B BIOCLONE 10ML3X10ML.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1824-2025·2025-06-04

    Abbott Rapid DX Multi Analyte Control Affected by Storage Temperature Excursion

    Abbott Rapid DX Multi Analyte Level 1 & 2 control products were exposed to temperatures outside recommended storage conditions due to transit delays caused by severe thunderstorms, which may result in incorrect or delayed test results.

    Product
    ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1840-2025·2025-06-04

    Abbott Diagnostics ARC Carbon Dioxide Calibrator Cold Chain Storage Issue

    Abbott Diagnostics ARC Carbon Dioxide 6x5mL B Calibrator units experienced transit delays due to severe thunderstorms, potentially exposing products to storage conditions outside the manufacturer's recommendations. This may increase the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC CARBON DIOXIDE6X5ML B CALIBRATOR.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1847-2025·2025-06-04

    Abbott ARCHITECT HBSAG Assay Reagent Recall Due to Storage Condition Failure

    Abbott ARCHITECT HBSAG Assay reagent may have been stored outside recommended conditions due to transit delays caused by severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARCHITECT HBSAG ASSAY(100TST/BX) BDS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1832-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS Phosphorus Reagent Recall

    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS reagent units may have been stored outside recommended cold chain conditions due to severe thunderstorms, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS PHOSPHORUS (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1846-2025·2025-06-04

    Abbott Point of Care Creatinine Test Cartridges Recalled for Storage Failure

    McKesson Medical-Surgical is recalling Abbott Point of Care Test Creatinine I-STAT cartridges distributed nationwide after transit delays during severe thunderstorms caused improper storage conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT POINT OF CARE TEST CREA I-STAT (25/BX) ABBTPT CARTRIDGE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1843-2025·2025-06-04

    Abbott Diagnostics ARC Anti-TPO Assay Reagent Affected by Transit Delays

    Abbott Diagnostics ARC Anti-TPO Assay 100TST B Reagent is being recalled because transit delays due to severe thunderstorms may have caused products to be stored outside recommended temperature conditions, increasing the risk of incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ARC ANTI-TPO ASSAY 100TST B REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1855-2025·2025-06-04

    HemoCue Glucose Control Kit Affected by Improper Storage During Transit

    HemoCue Glucose Aqueous Control Kit units may have been stored outside recommended conditions due to transit delays during severe thunderstorms, potentially affecting test result accuracy.

    Product
    HEMOCUE INC GLUC AQUEOUS 1HI/LO HEMCUE CONTROL KIT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1853-2025·2025-06-04

    Abbott Diagnostics Alinity I Anti-CCPS Reagent Recall

    Abbott Diagnostics Alinity I Anti-CCPS Reagent is being recalled due to transit delays from severe thunderstorms that may have exposed the product to storage conditions outside the manufacturer's recommendations, potentially causing incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS ALINITY I ANTI-CCPS REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1852-2025·2025-06-04

    Abbott Diagnostics Alinity I Free PSA Reagent Affected by Storage Conditions

    Abbott Diagnostics Alinity I Free PSA reagent units may have been stored outside recommended conditions due to transit delays from severe thunderstorms, potentially affecting test accuracy or timing.

    Product
    ABBOTT DIAGNOSTICS ALINITY I FREE PSA US(200TEST/EA) REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1839-2025·2025-06-04

    HemoCue HemoTrol High Control Product Recalled Due to Storage Conditions

    HemoCue Inc HemoTrol High Level 3 control product (Catalog No. 171003002) is being recalled because transit delays and severe thunderstorms may have caused it to be stored outside recommended temperature ranges, potentially resulting in incorrect or delayed test results.

    Product
    HEMOCUE INC HEMOTROL HIGH 2X1ML LEVEL 3 HEMCUE CONTROL.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1827-2025·2025-06-04

    HemoCue Glucose 201 Analyzer Microcuvettes Recalled for Storage Conditions

    HemoCue INC F/Glucose 201 Analyzer microcuvettes are being recalled due to transit delays caused by severe thunderstorms that may have resulted in storage outside recommended conditions, which could cause incorrect or delayed test results.

    Product
    HEMOCUE INC F/GLUCOSE 201 ANALYZER (25/VL 4VL/BX) MICROCUVETTE.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1837-2025·2025-06-04

    ORTHO CLINICAL DIAGNOSTICS VITROS BUN Reagent Recall Nationwide

    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN clinical reagent is being recalled due to transit delays caused by severe thunderstorms that may have exposed products to improper storage conditions, risking incorrect or delayed test results.

    Product
    ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1829-2025·2025-06-04

    BD Microbiology MacConkey II Agar Media Storage Condition Recall

    BD Microbiology MacConkey II Agar media may have been stored outside recommended temperature conditions due to transit delays from severe thunderstorms, potentially resulting in incorrect or delayed test results.

    Product
    BD MICROBIOLOGY MAC CONKEY II AGAR (100/CT) 21270 MEDIA.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1841-2025·2025-06-04

    Abbott Diagnostics Probe Conditioning Solution Recall

    Abbott Diagnostics Probe Conditioning Solution for Architect analyzers is being recalled due to cold chain failures during severe thunderstorms. Products may have been stored outside recommended conditions, risking incorrect or delayed test results.

    Product
    ABBOTT DIAGNOSTICS PROBE CONDITIONING F/ARCHITECT ANLYZ ABBDIA SOLUTION.
    Category
    Medical Device
    Distribution
    Distributed nationwide