The Recall Desk

State

Maine product recalls

72,820 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 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

326–350 of 76714

  • HighFDA (Devices)·Z-2883-2026·2026-08-12

    Knee Prosthesis Trial Recall for Manufacturing Defect

    United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.

    Product
    Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2884-2026·2026-08-12

    USTAR II Knee System Hinge Box Trial Recall

    United Orthopedic Corp. is recalling USTAR II Knee System Hinge Box Trials due to a manufacturing defect that could prevent proper assembly of the stem trial component.

    Product
    Brand Name: USTAR II Knee System Product Name: Hinge Box Trial, L, #1-6 and Hinge Box Trial, R, #1-6 Model/Catalog Number: 9325-5711 thru 9325-5716 and 9325-5721 thru 9325-5726 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2878-2026·2026-08-12

    GE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability

    GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.

    Product
    GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2904-2026·2026-08-12

    Tissium COAPTIUM CONNECT Nerve Repair Device Shelf Life Recall

    Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device because the labeled 36-month shelf life is not supported by real-time data; the validated shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2075 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2906-2026·2026-08-12

    COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling

    TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2861-2026·2026-08-12

    DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results

    Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.

    Product
    Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chai
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2898-2026·2026-08-12

    United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings

    United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2858-2026·2026-08-12

    Medical Action Industries Recalls Dialysis Change Tray Kits Due to Seal Defect

    Medical Action Industries is recalling 3,740 Dialysis Change Tray Clear Sequence kits because the needle-free access device may have an improper seal.

    Product
    Brand Name: Medical Action Industries Product Name: Dialysis Change Tray Clear Sequence Model/Catalog Number: 78791
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2892-2026·2026-08-12

    Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures

    Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.

    Product
    Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 7222
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·26E055000·2026-08-12

    Mack Recalls Grote Replacement Marker Lights for Visibility Failure

    Mack Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.

    Product
    GROTE — GROTE CLEARANCE/MARKER LAMP
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2901-2026·2026-08-12

    COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.

    Product
    Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2874-2026·2026-08-12

    Merge PACS Medical Imaging Workstation Recalled Due to Patient Data Display Error

    Merge Healthcare is recalling 53 Merge PACS medical imaging workstations due to a software issue where thumbnails from one patient's study may incorrectly display when viewing a different patient's study, potentially compromising patient confidentiality.

    Product
    Merge PACS, medical imaging diagnostic workstation
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2902-2026·2026-08-12

    Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life

    Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.

    Product
    Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2890-2026·2026-08-12

    Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall

    Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.

    Product
    Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2886-2026·2026-08-12

    United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System

    United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.

    Product
    Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product De
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2893-2026·2026-08-12

    Philips Fluoroscopy System Recall Over Hard Disk Drive Issue

    Philips is recalling 257 Allura/Centron interventional fluoroscopic X-ray systems due to potential loss of imaging, motorized movement, or data caused by unauthorized hard disk drives.

    Product
    Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Interventional Fluoroscopic X-Ray System.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2844-2026·2026-08-12

    Quantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue

    Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.

    Product
    Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2865-2026·2026-08-12

    Stryker Single Spike Tube Set Recalled for Leaking During Use

    Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.

    Product
    STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2846-2026·2026-08-12

    Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall

    Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.

    Product
    Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2848-2026·2026-08-12

    Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks

    The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.

    Product
    Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2863-2026·2026-08-12

    Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use

    Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.

    Product
    STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2859-2026·2026-08-12

    Anti-Torque Instrument in Vector Pedicle Screw System Recalled

    Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.

    Product
    Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2851-2026·2026-08-12

    Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues

    A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.

    Product
    Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2836-2026·2026-08-12

    FORWARD Oral Airway Kit Recall for Potential Airway Obstruction

    Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.

    Product
    FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
    Category
    Medical Device
    Distribution
    Distributed nationwide