State

Maine product recalls

73,218 recalls have nationwide distribution and so reach Maine. 3,922 additional recalls listed Maine specifically in their distribution scope.

What the numbers show

Total: 3,922
Critical: 478
Severe: 803
Most recent: 2026-09-23

Of the 3,922 recalls naming Maine we have scored against our rubric, 478 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 803 (20%) are Severe.

Which agencies issued them

These figures cover only the 3,922 recalls whose distribution notice names Maine specifically. The 73,218 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

13651–13675 of 77140

HighFDA (Devices)·Z-0609-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridge Sodium Sensor Negative Bias Risk
Siemens RAPIDPoint 500 measurement cartridges may produce inaccurate sodium readings, risking delayed diagnosis of dangerous electrolyte imbalances or unnecessary treatment.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491449
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0559-2024·2023-12-27
Philips Azurion Ceiling-Mount Systems Rotation Cover May Fall
Philips is recalling Azurion ceiling-mount imaging systems because a rotation cover may fall if the L-arm collides with hospital equipment, potentially causing injury or affecting sterilization.
Product
Philips Azurion systems with monoplane fixed ceiling mounts: 722078 Azurion 7 M12 722079 Azurion 7 M20 722223 Azurion 7 M12 722224 Azurion 7 M20 722227 Azurion 5 M12 722228 Azurion 5 M20
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0579-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for vacuum loss in bags
Exactech Equinoxe Reverse Shoulder implants have been recalled due to loss of vacuum in the storage bag. The manufacturer received 3 complaints involving 4 devices.
Product
Exactech Equinoxe Reverse Shoulder System, Catalog Numbers: a) 320-36-00, b) 320-36-03, c) 320-36-04, d) 320-36-10, e) 320-36-13, f) 320-38-00, g) 320-38-13, h) 320-40-00, i) 320-40-10, j) 320-42-00, k) 320-42-10, l) 320-42-13, m) 320-46-10, n)…
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0567-2024·2023-12-27
AC Power Adapter for LIFEPAK 15 Defibrillator May Fail to Charge or Power On
AC power adapters for LIFEPAK 15 Monitor/Defibrillators may fail to charge batteries or power on the device. Physio-Control is recalling 18,732 units manufactured between November 2021 and April 2023.
Product
AC Power Adapter for use with the LIFEPAK 15 Monitor/Defibrillator, REF: 11140-000098
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0576-2024·2023-12-27
Philips Inclusive CT Systems: Software Errors in Image Display and Interpretation
Philips North America is recalling 330 Philips Inclusive CT imaging systems due to software issues causing incorrect image display, errors in image interpretation, and patient exposure to incorrect images and system functions during clinical use.
Product
The device is a whole-body CT x-ray system. The acquired x-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. The system also includes signal analysis and display equipment, patient and equipment…
Category
Medical Device
Distribution
25 states
HighFDA (Devices)·Z-0581-2024·2023-12-27
Exactech Novation Hip System Recalled for Vacuum Seal Loss
Exactech is recalling the Novation Hip System due to loss of vacuum in the sterile packaging. The company has received complaints about this defect affecting 4 devices.
Product
Exactech Novation Hip System, Catalog Numbers: 134-36-45
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0585-2024·2023-12-27
Exactech Truliant Knee System Recalled Due to Vacuum Bag Failure
Exactech recalls certain Truliant Knee System units due to loss of vacuum in the inner vacuum bag. The affected units were distributed across multiple U.S. states and international locations.
Product
Exactech Truliant Knee System, Catalog Numbers: a) 02-012-35-3509, b) 02-022-35-1509, c) 02-022-35-1513, d) 02-022-35-3010, e) 02-022-35-3509, f) 02-022-35-3510, g) 02-022-35-3511, h) 02-022-35-4511, i) 02-022-44-3512, j) 02-022-47-2509, k) 02-022-51-4519
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0558-2024·2023-12-27
Philips Allura Medical Imaging Systems Ceiling Mount May Fall
Philips is recalling Allura imaging systems where the ceiling-mounted rotation cover may fall during equipment collisions, risking injury or sterility issues. Approximately 9,991 units are affected worldwide.
Product
Philips Allura systems with monoplane fixed ceiling mounts: 722001 Allura Xper FD10C 722003 Allura Xper FD10 722006 Allura Xper FD20 722010 Allura Xper FD10 722012 Allura Xper FD20 722015 Allura Xper FD20 OR Table 722016 Integris H5000 C / Allura 9C 722018 Integris…
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0583-2024·2023-12-27
Exactech Optetrak Logic Knee System Recalled for Vacuum Bag Failure
Exactech is recalling certain Optetrak Logic Knee System devices due to loss of vacuum in the inner-most vacuum bag. The company has received three complaints involving four affected devices.
Product
Exactech Optetrak Logic Knee System, Catalog Numbers: a) 02-012-47-3011, b) 02-012-47-5009, c) 02-012-47-5011, d) 02-012-65-3013
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0587-2024·2023-12-27
Exactech Vantage Ankle System Recalled Due to Vacuum Loss
Exactech is recalling two catalog numbers of Vantage Ankle System devices due to loss of vacuum in the inner-most vacuum bag. Three complaints have been received relating to four affected devices.
Product
Exactech Vantage Ankle System, Catalog Numbers: a) 350-21-04, b) 350-22-03
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0601-2024·2023-12-27
Siemens epoc NXS Blood Analysis System Software Causes Erroneous Test Results
Siemens epoc NXS blood analysis systems have a software defect causing incorrect test results to be printed or transmitted. Results may include data from previous patients, potentially leading to misdiagnosis.
Product
epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506 (CA), 11413517 (MX), 11413518 (ROW), 11413498 (JP), 11413583 (CN, KR), 11413879 (IN) with software versions from 4.9.4 to the current version 4.11.11
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0606-2024·2023-12-27
RAPIDPoint 500 Measurement Cartridges Recalled for Sodium Sensor Bias
Siemens is recalling RAPIDPoint 500 Systems Measurement Cartridges because the sodium sensor can develop a negative measurement bias that could delay diagnosis of serious electrolyte disorders or cause treatment errors.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10844813
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0607-2024·2023-12-27
RAPIDPoint 500 Diagnostic Cartridges Recall Due to Sodium Sensor Measurement Bias
Siemens is recalling RAPIDPoint 500 measurement cartridges because the sodium sensor can produce inaccurate readings, potentially leading to delayed diagnosis or incorrect treatment of electrolyte imbalances.
Product
RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use and is designed to provide the determination in whole blood. SMN: 10491447
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0605-2024·2023-12-27
Venous probe connection cable defects in Cardiohelp-i extracorporeal support systems
Maquet Medical Systems USA is recalling venous probe connection cables for the Cardiohelp-i System due to insulation and wire breaks. Defective cables may prevent the system from receiving critical blood flow and temperature information.
Product
Venous probe connection cable (REF 701069333 and 701048804) used with the Cardiohelp-i System, part numbers 701072780 and 701041802
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0577-2024·2023-12-27
AcuMatch Hip System Recalled for Loss of Vacuum Integrity
Exactech is recalling AcuMatch Hip System devices due to loss of vacuum in the inner-most vacuum bag, with 3 complaints reported affecting 4 devices. Vacuum loss could compromise device packaging integrity.
Product
AcuMatch Hip System, Catalog Number 142-32-27
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0588-2024·2023-12-27
Exactech Vantage Mobile Bearing Tibial Inserts Recalled Due to Vacuum Loss
Exactech is recalling Vantage Mobile Bearing Tibial Inserts due to loss of vacuum in the innermost vacuum bag. Three complaints involving four devices have been reported.
Product
Exactech Vantage Mobile Bearing Tibial Inserts, Catalog Numbers: a) 350-41-23, b) 350-42-03
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0584-2024·2023-12-27
Exactech Optetrak Logic PS Knee System Vacuum Loss Recall
Exactech is recalling certain Optetrak Logic PS Knee Systems due to potential loss of vacuum in the inner-most vacuum bag. The company has received 3 complaints involving 4 devices.
Product
Exactech Optetrak Logic PS Knee System, Catalog Numbers: 02-012-35-5009
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0580-2024·2023-12-27
Exactech Equinoxe Shoulder System recalled for loss of vacuum
Exactech is recalling specific models of its Equinoxe Shoulder System implants due to loss of vacuum in the inner-most vacuum bag. Four devices have been affected according to three complaints received.
Product
Exactech Equinoxe Shoulder System, Catalog Numbers: a) 314-23-02, b) 314-23-03, c) 314-23-13, d) 314-23-14, e) 314-23-15, f) 314-24-22, g) 314-24-23, h) 314-24-24, i) 314-24-32, j) 314-24-33, k) 314-24-34, l) 314-24-35
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0582-2024·2023-12-27
Exactech Optetrak Knee Implant System Recalled for Vacuum Seal Failure
Exactech is recalling specific catalog numbers of the Optetrak Knee Implant System due to loss of vacuum in the protective inner bag. Three complaints affecting four devices have been reported.
Product
Exactech Optetrak Knee System, Catalog Numbers: a) 200-02-26, b) 200-02-29, c) 200-02-32, d) 200-02-35, e) 200-02-38, f) 200-02-41, g) 200-03-32, h) 200-07-29, i) 200-07-32, j) 200-07-35, k) 204-21-13, l) 204-22-26, m) 208-23-18, n) 208-24-13
Category
Medical Device
Distribution
16 states
HighFDA (Devices)·Z-0578-2024·2023-12-27
Hip Implant Liner Recalled Due to Loss of Vacuum in Inner Bag
Exactech has recalled certain Alteon Hip XLE Liner hip implant components due to vacuum loss in the inner vacuum bag. The company has received 3 complaints involving 4 devices related to this issue.
Product
Exactech Alteon Hip XLE Liner, Catalog Numbers: a) 01-030-40-0636, b) 01-030-40-0640, c) 01-030-42-0536
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0560-2024·2023-12-27
Roche Cobas Interface Module Firmware May Cause Delayed Sample Processing
Inpeco is recalling firmware versions for the Roche Cobas 8000 and PRO Interface Module that may cause delayed sample tube processing in laboratory automation systems.
Product
Roche Cobas 8000 and Cobas PRO Interface Module (CO8 IM)- IVD FlexLab Automation System -a modular system designed to automate Pre-Analytical and Post-Analytical processing, sample handling in order to automate sample processing in the Laboratory. Hardware versions…
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0586-2024·2023-12-27
Exactech knee replacement inserts recalled for vacuum seal loss
Exactech is recalling Truliant and Activit-E knee replacement inserts for loss of vacuum in storage packaging. The defect was identified in 3 complaints involving 4 devices, with no reported injuries.
Product
Exactech Truliant, Activit-E Knee Insert, Catalog Numbers: a) 02-023-02-0029, b) 02-023-02-0032, c) 02-023-02-0035, d) 02-023-02-0038, e) 02-024-35-1512, f) 02-024-35-1515, g) 02-024-35-1519, h) 02-024-35-2010, i) 02-024-35-2013, j) 02-024-35-2015, k)…
Category
Medical Device
Distribution
16 states
ModerateFDA (Devices)·Z-0595-2024·2023-12-27
CARDIOHELP-i Heart-Lung Support System not properly tested for leakage current
The CARDIOHELP-i Heart-Lung Support System was not properly tested to measure leakage current, an electrical safety concern. The FDA is recalling 1,594 units distributed worldwide.
Product
CARDIOHELP-i Heart Lung Support System: Blood oxygenation and carbon dioxide removal system used to pump blood through the extracorporeal bypass circuit for circulatory and/or pulmonary support for periods appropriate to cardiopulmonary bypass (up to six hours). Product REF…
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·23V900000·2023-12-26
Volvo Recalls One 2020 VNL Truck for Steering Gear Assembly Defect
Volvo Trucks North America is recalling one 2020 VNL truck because the steering gear assembly may have been assembled with fewer recirculating balls than required, potentially causing a loss of steering control.
Product
VOLVO — VOLVO VNL
Category
Vehicle
Distribution
Distributed nationwide
HighNHTSA·23V899000·2023-12-26
2024 Mack Commercial Trucks Steering Gear Assembly Defect Recall
Mack is recalling approximately 284 certain 2024 Pinnacle, Anthem, and Terrapro commercial trucks with incorrectly assembled steering gear assemblies that could cause loss of steering control and increase crash risk. Dealers will inspect and replace defective gears free of charge.
Product
MACK — MACK ANTHEM (AN), PINNACLE (PI/PN), TERRAPRO (TE)
Category
Vehicle
Distribution
Distributed nationwide