The Recall Desk

State

Maine product recalls

72,992 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.

Which agencies issued them

These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7276–7300 of 76886

  • HighFDA (Devices)·Z-1378-2025·2025-03-26

    Microstream CO2 sampling lines recalled for difficult adapter disconnection

    Microstream CO2 sampling lines may be difficult to disconnect from endotracheal tubes, potentially delaying treatment or causing unintended tube removal.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Filter Line Sets Adult/Pediatric & Infant/Neonatal, 10129497 - CapnoLine Neonatal-Infant Intubated Filter Line with Microstream Technology H, Length 7 (2.0 m), 006324COV; CapnoLine
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1360-2025·2025-03-26

    Lumbar Spine Pack Recalled Due to Sterilization Assurance Failure

    American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.

    Product
    SPINE LUMBAR PACK , Model No UTSL72AA UTSL72AB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1361-2025·2025-03-26

    Thoracic Packs Recalled for Unconfirmed Sterilization Assurance by Manufacturer

    American Contract Systems recalls 40 kits of Thoracic Packs (Models UTTC82Y and UTTC82AA-01) due to inability to confirm sterilization assurance was met. Unsterilized packs may lose functionality and delay emergency treatment.

    Product
    THORACIC PACK , Model No UTTC82Y UTTC82AA-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1349-2025·2025-03-26

    Laceration Trays Recalled Due to Sterility Assurance Concerns

    American Contract Systems Inc recalled 690 laceration trays because the company cannot confirm sterilization assurance requirements were met. The recalled devices may lose functionality, potentially delaying or prolonging patient treatment.

    Product
    LACERATION TRAY , Model No SGLA07A SGLA07B-01 SGLA07B-02 SGLA07B
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1339-2025·2025-03-26

    Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed

    American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.

    Product
    OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0284-2025·2025-03-26

    CVS Health Concealing Acne Treatment Cream Recalled for Benzene Contamination

    Fruit Of The Earth, Inc. is recalling CVS Health Concealing Acne Treatment Cream due to the presence of benzene, a chemical contaminant. The affected product was distributed nationwide.

    Product
    CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0277-2025·2025-03-26

    Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Safe Levels

    Rising Pharma is recalling Duloxetine Delayed-Release Capsules 30 mg (Lot DTB23111A) distributed nationwide due to N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This manufacturing impurity resulted from a CGMP deviation.

    Product
    Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1344-2025·2025-03-26

    Labor and Delivery System Recalled for Sterilization Assurance Issue

    American Contract Systems is recalling 1,836 Labor and Delivery PPS kits due to inability to confirm sterilization requirements were met. The affected units may lose functionality, potentially delaying patient treatment.

    Product
    LABOR & DELIVERY PPS , Model No LLLD64O LLLD64O-01 LLLD64O-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1336-2025·2025-03-26

    C-Section Surgical Packs Recalled Over Sterilization Assurance Failure

    American Contract Systems is recalling C-Section surgical packs (252 kits) after being unable to confirm sterilization assurance. Lack of verified sterilization could delay or prolong surgical treatment.

    Product
    C-SECTION PACK, Model Nos LLCS44F LLCS44F-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1392-2025·2025-03-26

    Medical Device Software May Merge Patient Records Without Notification

    Brainlab's Origin Data Management software versions 3.1.0 through 3.2.1 may automatically merge patient records from unrelated individuals without user notification, creating a risk of incorrect patient data being used in clinical care.

    Product
    Origin Data Management software versions 3.1.0, 3.1.1, 3.1.2, 3.2.0, 3.2.1
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1363-2025·2025-03-26

    Medline Proxima sterile surgical drapes recalled due to potential packaging breach

    Medline is recalling 1,482 units of Proxima sterile surgical drapes due to potential breaches in pouch packaging that could compromise sterility. No illnesses have been reported.

    Product
    Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW; SHEET, DRAPE, SPLIT, ST,10/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,LAPROSCOPY,CHOLE,W/TROUGH,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,ABDOMINAL,MAJOR,ST,8/CS; DRAPE,SPLIT,CVMAX,6/CS; DRAPE,ORTHOMAX ,BAR,6/CS; DRA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1362-2025·2025-03-26

    Vein Tray Models UTVT21C Unable to Confirm Sterilization Assurance

    American Contract Systems Inc is recalling certain Vein Tray models because sterilization assurance requirements could not be confirmed. The affected units may lack functionality and could lead to delayed treatment.

    Product
    VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1359-2025·2025-03-26

    Cardiac Surgical Training Kits Recalled for Sterilization Verification Failure

    American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.

    Product
    OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1342-2025·2025-03-26

    Surgical Positioning Device Recalled for Unconfirmed Sterilization Assurance

    American Contract Systems Inc is recalling C-Section PPS positioning systems due to inability to confirm sterilization assurance requirements were met. The failure could lead to loss of functionality and delayed treatment.

    Product
    C-SECTION PPS , Model No LLCI66M LLCI66M-02 LLCI66M-03 LLCI66M-04
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1383-2025·2025-03-26

    Microstream CO2 Sampling Line May Not Disconnect From Intubation Tube

    Microstream intubated CO2 sampling lines may be difficult or impossible to disconnect from endotracheal tubes. This could delay necessary procedures and cause unintended extubation, potentially leading to respiratory failure.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Microstream Luer Intubated Adult Pediatric, PT00156355 - Microstream Luer Adult-Pediatric Intubated CO2 Sampling Line 2m/6.5ft Short-term use: Procedural/Emergency, MLAI
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1347-2025·2025-03-26

    Hip Prosthesis Pack Recalled Due to Sterilization Assurance Concerns

    American Contract Systems Inc is recalling TOTAL HIP PACK models SMTH06O and SMTH06P due to inability to confirm sterilization requirements were met. Unsterilized devices could malfunction and delay patient treatment.

    Product
    TOTAL HIP PACK , Model No SMTH06O SMTH06P
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1354-2025·2025-03-26

    Diagnostic Neuro IR Tray recalled for unconfirmed sterilization

    American Contract Systems Inc is recalling 170 Diagnostic Neuro IR Tray kits due to inability to confirm sterilization assurance requirements were met. The units may lose functionality and cause treatment delays.

    Product
    DIAGNOSTIC NEURO IR TRAY , Model No WENE21
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1370-2025·2025-03-26

    Surgical drapes recalled due to potential sterility breach in packaging

    Medline Industries is recalling Proxima Drape surgical drapes nationwide due to a potential breach in pouch packaging that could lead to loss of sterility. The recall affects 1,118 units distributed in the US.

    Product
    Proxima Drape labeled as ORTHO TRAUMA CDS, TOTAL KNEE AUX PACK, TOTAL HIP PACK, TOTAL HIP, TOTAL KNEE, SPINE. Sterile surgical drape.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1377-2025·2025-03-26

    Microstream CO2 Sampling Lines May Be Difficult to Disconnect From Breathing Tubes

    Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: FilterLine Sets & VitaLine Sets Adult/Pediatric, MQ04616 - MICROSTREAM FilterLine H Set Long Adult-Pediatric CO2 Sampling Line and Airway Adapter for Humid Environments, 007737; MICR
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0290-2025·2025-03-26

    Levothyroxine Sodium Tablets Recalled for Out-of-Specification Potency

    Mylan Institutional is recalling Levothyroxine Sodium Tablets 150 mcg due to out-of-specification potency. The medication tested higher than specified, affecting 347 cartons distributed nationwide (Lot 3116074, expires 09/30/2025).

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1343-2025·2025-03-26

    PICC Line Catheters Recalled for Sterilization Assurance Issues

    American Contract Systems is recalling PICC line catheters because sterilization assurance requirements could not be confirmed. Unsterilized devices may lose functionality and delay patient treatment.

    Product
    CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1379-2025·2025-03-26

    CO2 Sampling and Airway Adapter Devices May Be Difficult to Disconnect

    Oridion Medical's CO2 sampling and airway adapter devices may be difficult to disconnect from endotracheal tubes, potentially causing treatment delays and serious respiratory complications in neonatal, infant, and pediatric patients.

    Product
    Microstream Instructions for Use and Part Number used with - Product Description, REF: Airway Adapter and CO2 Sampling Line, 01158 - Microstream Luer Adult-Pediatric Airway Adapter, 010989; Omnistream CO2 Sampling Line X25, 010991
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0278-2025·2025-03-26

    Cinacalcet Hydrochloride Tablets Recalled for Nitrosamine Impurity

    Slate Run Pharmaceuticals is recalling Cinacalcet Hydrochloride Tablets 30 mg due to nitrosamine impurity above acceptable daily intake limits. 56,790 bottles were distributed to 8 wholesalers nationwide.

    Product
    Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-007-04
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1341-2025·2025-03-26

    Birth Delivery Kit Recalled Due to Unconfirmed Sterilization Assurance

    American Contract Systems Inc recalls the Born on Arrival Kit due to inability to confirm sterilization assurance. Unsterilized equipment could delay or prolong newborn treatment.

    Product
    BORN ON ARRIVAL KIT , Model No LLBN11B
    Category
    Medical Device
    Distribution
    Distributed nationwide