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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
The affected products may have been packaged with a defect in the sterile barrier seal. As a result, the integrity of the sterile barrier may be compromised.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
During sterile barrier testing performed on the decanter product line, the samples were identified to have pin holes and tears in the packaging film.
Potential issue causing a higher frequency of interference with locking screws and/or inserter rods than anticipated, resulting in screws stripping and/or not fully seating in the plates and/or interface issues between inserter rods and plates.
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
There is a potential for inadvertent tidal volume knob movement from the original setting when set at high (1000-1500 mL) and low (70-150 mL) settings.
G5 Semi-Automatic AED is shipped, with a protective film over its front panel, to protect the screen and shock button from cosmetic damage during shipping. It has come to our attention that customers may not be removing the protective film during deployment of the product. If the protective film is left adhered to the front bezel it may prevent the user from actuating the shock button and may lead to a delay or prevent delivery of defibrillation therapy to a victim suffering from sudden cardiac arrest
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Thermo King Corp. (Thermo King) is recalling certain Tripac-3 Auxiliary Power Units (APU) with part number 800908, manufactured between April 8, 2024, and May 15, 2024. The APU mounting kits contain mounting bolts that are too short and can loosen.
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Difficulties in pairing the wireless footswitch with the Soltive Laser, potentially delaying the surgical procedure.
Smiths Medical became aware of an issue related to a potential for the patient outlet connector to loosen/detach from the paraPAC Plus P300 and P310 ventilators impacting the active ventilation function.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Oshkosh Corporation (Oshkosh) is recalling certain Shepphard Steering Gears, with part number 3875726, sold as replacement parts for certain S-Series vehicles. The steering gears may have been assembled incorrectly, which can cause the gear to fracture.
Mislabeling; tourniquet cuff packaging labeled as dual port single bladder but contains a tourniquet cuff single port single bladder.
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.