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.

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.

7526–7550 of 76886

  • HighFDA (Devices)·Z-1247-2025·2025-03-05

    Leica Biosystems Cryostat CM1950 Firmware Update May Cause Tissue Loss

    A software issue in the Leica Biosystems CM1950 cryostat firmware update could result in loss of patient tissue. Serial numbers 12835 and 12854 are affected.

    Product
    Brand Name: Leica Biosystems Cryostats Product Name: CM1950 Model/Catalog Number: 1491950C4US Software Version: firmware V3.01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1211-2025·2025-03-05

    Tyber Medical recalls A.L.P.S. mvX Anatomic Lateral Fibula Plates due to screw malposition

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates (418 units, nationwide) because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX -ANATOMIC LAT FIB PLATE 6H LT- Anatomic Lateral Fibula Plate, 6-hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1238-2025·2025-03-05

    Pentax EPK-i8020c Video Processor Recalled for Thermal Burn Risk

    Pentax EPK-i8020c video processors can overheat during endoscopic procedures, creating a risk of thermal burns to patient tissues. The light guide tip becomes hot and may cause injury to mucous membranes.

    Product
    Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation. Model: EPK-i8020c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1222-2025·2025-03-05

    Orthopedic Tibia Plate Locking Screw Malfunction Nationwide Recall

    Tyber Medical is recalling 209 A.L.P.S. mvX Medial Tibia plates nationwide due to reports that locking screws can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 10H RT-Medial Tibia Plate, 10-Hole, Right Intended Fixation of fractures of the distal tibia. Model/Catalog Number: 770715102
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1223-2025·2025-03-05

    FDA Recalls Medial Tibia Plates for Intra-operative Screw Failure

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates due to reports that the locking screw can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 12H LT-Medial Tibia Plate, 12-Hole, Left Intended forFixation of fractures of the distal tibia Model/Catalog Number: 770715121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1214-2025·2025-03-05

    Orthopedic Surgical Plates Recalled Due to Intra-Operative Locking Screw Malfunction

    Tyber Medical is recalling A.L.P.S. mvX Anatomic Lateral Fibula Plates nationwide due to reports that locking screws may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H RT: Anatomic Lateral Fibula Plate, 8-hole, Right Indicated for use in Fixation of fractures of the distal tibia Model/Catalog Number: 77070802
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0246-2025·2025-03-05

    Estradiol Gel Recalled Nationwide for Defective Packet Sealing

    Padagis US LLC recalls Estradiol Gel 0.1% nationwide due to defective packets that may not be fully sealed, potentially allowing ethanol loss.

    Product
    Estradiol Gel, 0.1%, 0.25 mg/g, 30 packets per carton, Rx Only, For Topical Use Only, Manufactured by Padagis, Yeruham, Israel, NDC: 45802-0134-30
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighNHTSA·25T002000·2025-03-05

    Sumitomo Recalls Dunlop GPR-300F Tires Due to Inner Liner Defect

    Sumitomo is recalling specific Dunlop GPR-300F tires due to a defect causing inner liner bulging. The defect may lead to sudden air loss and vehicle control issues.

    Product
    TIRES recall
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1235-2025·2025-03-05

    Plato 17 Microcatheter Recall Due to Sterile Barrier Packaging Defect

    Scientia Vascular is recalling Plato 17 Microcatheter units due to manufacturing defects in the packaging seal that could compromise sterility during vascular procedures.

    Product
    Plato 17 Microcatheter REF PL17-160-090 To assist in delivery of therapeutic devices and embolization materials and infusion of diagnostic agents to the neuro and peripheral vasculature during interventional or diagnostic procedures.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V144000·2025-03-05

    Mercedes-Benz Tourrider Buses Recalled for Missing Driver Seat Bracket

    Daimler Coaches is recalling 2022-2025 Mercedes-Benz Tourrider buses because a missing driver's seat bracket may allow the backrest to fold forward in a crash.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ TOURRIDER PREMIUM, TOURRIDER BUSINESS
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1212-2025·2025-03-05

    A.L.P.S. mvX Fibula Plate Recall: Locking Screw Malfunction During Surgery

    Tyber Medical is recalling 408 units of the A.L.P.S. mvX Anatomic Lateral Fibula Plate because the locking screw can pass through the locking hole during surgery, causing surgical delays. No injuries have been reported.

    Product
    A.L.P.S. mvX- ANATOMIC LAT FIB PLATE 6H RT: Anatomic Lateral Fibula Plate, 6-hole, Right Model/Catalog Number: 770708062
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1226-2025·2025-03-05

    Medial Tibia Plate Recall Due to Locking Screw Malfunction During Surgery

    Tyber Medical recalls 109 units of the A.L.P.S. mvX Medial Tibia Plate nationwide due to reports of the locking screw passing through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 16H RT -Medial Tibia Plate, 16-Hole, Right Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715162
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1243-2025·2025-03-05

    GE SIGNA MR380 NMRI System SAR Limit Exceeded During Scan Resumption

    GE SIGNA MR380 NMRI systems may allow scans to resume when the 6-minute average SAR (tissue heating rate) exceeds safe limits, potentially causing excessive tissue heating especially in patients with implants or conductive contact.

    Product
    SIGNA MR380, NMRI system, Non-US Only
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1240-2025·2025-03-05

    MRI System May Resume Scanning Above Safe Thermal Limits

    GE Healthcare's Brivo MR355 MRI system can incorrectly resume scans when tissue heating limits are exceeded, potentially causing thermal burns if patients contact conductive materials. The recall affects 22 systems distributed nationwide and internationally.

    Product
    Brivo MR355, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1224-2025·2025-03-05

    A.L.P.S. mvX Medial Tibia Plate Locking Screw Malfunction Recall

    Tyber Medical recalls 208 units of A.L.P.S. mvX Medial Tibia Plates due to locking screws that can pass through the locking hole during surgery, causing surgical delays. No patient injuries have been reported.

    Product
    A.L.P.S. mvX--MEDIAL TIBIA PLATE 12H RT-Medial Tibia Plate, 12-Hole, Right Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715122
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1234-2025·2025-03-05

    Socrates 38 Aspiration Catheter Recall Due to Sterile Barrier Defect

    Scientia Vascular is recalling 120 Socrates 38 Aspiration Catheters due to manufacturing defects that created channels in the packaging seal. The defect could potentially compromise the sterile barrier on devices used for acute stroke treatment.

    Product
    Socrates 38 Aspiration Catheter 127 cm length REF SC038-127-001 The Socrates Aspiration System with a compatible suction pump is intended for use in the revascularization of patients with acute ischemic stroke
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1230-2025·2025-03-05

    BD Pyxis MedBank medication cabinets recalled for operating room contraindication labeling

    CareFusion is recalling BD Pyxis MedBank medication management cabinets due to inadequate labeling. A contraindication statement must be added to warn against use in procedure and operating rooms.

    Product
    139088-01 BD PYXIS MEDBANK MEDPASS MODULE 169-151 BD PYXIS MEDBANK MINI 1FH-2HH MEDPASS 169-152 BD PYXIS MEDBANK MINI 2HH-1FM MEDPASS 169-150 BD PYXIS MEDBANK MINI 4HH MEDPASS 169-140 BD PYXIS MEDBANK TWR MN 3FH-8HH MEDPASS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·25V142000·2025-03-05

    Blue Arc BA4L-800 Recalled for Headlight Adjustment Defect

    Shyft Group is recalling 2024-2025 Blue Arc BA4L-800 vehicles because missing headlight covers allow beam adjustment, potentially causing glare or reduced visibility.

    Product
    BLUE ARC — BLUE ARC BA4L-800
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1241-2025·2025-03-05

    GE Healthcare MRI system recalled for RF energy safety control failure

    GE Healthcare's Optima MR360 MRI systems may allow unsafe RF energy exposure if a scan resumes after power loss. The user interface can incorrectly enable scanning when tissue-heating levels exceed safe limits.

    Product
    Optima MR360, NMRI system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1221-2025·2025-03-05

    Medial Tibia Plate Recall: Locking Screw Defect During Surgery

    Tyber Medical is recalling A.L.P.S. mvX Medial Tibia Plates because the locking screw may not properly secure during surgery, causing surgical delays. No injuries have been reported.

    Product
    A.L.P.S. mvX- MEDIAL TIBIA PLATE 10H LT- Medial Tibia Plate, 10-Hole, Left. Intended Fixation of fractures of the distal tibia Model/Catalog Number: 770715101
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1219-2025·2025-03-05

    Orthopedic tibia plate locking screw failure causes surgical delays

    Tyber Medical recalls A.L.P.S. mvX Medial Tibia plates; the locking screw can pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-MEDIAL TIBIA PLATE 6H LT-Medial Tibia Plate, 6-Hole, Left Intended for Fixation of fractures of the distal tibia Model/Catalog Number: 770715061
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1231-2025·2025-03-05

    Infusion Pump Manual Instructs Users to Leave Safety Clamp Open

    BD Alaris Pump Module user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets, potentially causing accidental over-infusion.

    Product
    BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administra
    Category
    Medical Device
    Distribution
    51 states
  • HighFDA (Devices)·Z-1217-2025·2025-03-05

    Orthopedic Plate Locking Screw May Pass Through Hole During Surgery

    Tyber Medical is recalling A.L.P.S. mvX-P Anatomic Lateral Fibula Plates because the locking screw may pass through the locking hole during surgery, causing surgical delays.

    Product
    A.L.P.S. mvX-P: ANATOMIC LAT FIB PLATE 12H LT- Anatomic Lateral Fibula Plate, 12-Hole, Left. Inended for Fixation of fractures of the distal tibia Model/Catalog Number: 770708121
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1237-2025·2025-03-05

    PENTAX Medical Video Upper GI Endoscope Thermal Burn Risk Recall

    Pentax of America is recalling 138 PENTAX Medical Video Upper GI Scopes due to a thermal injury risk. The light guide tip can become excessively hot during endoscopic procedures, potentially burning patient tissue.

    Product
    PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract Model: EG29-i20c
    Category
    Medical Device
    Distribution
    Distributed nationwide