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All product recalls affecting Maine.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maine in the distribution area.
Respiratory pathogen panel may report an elevated rate (7.6% predicted probability of occurrence) of non-specific hMPV target (human Metapneumovirus) results, risk identified predominantly in clinical samples that present positivity for another target, leading to an erroneous co-infection result, can potentially result in hMPV false positives.
May exhibit endotoxin levels greater than 2.15 EU/device, fever and inflammation may occur from endotoxin exposure and meningitis may only occur if there is contact with cerebrospinal fluid and thus, neurosurgical/spinal procedures may be considered a population at greatest risk.
Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was connected to the AVVIGO+ Multi-Modality Guidance System while in either Live or Record mode. The Boston Scientific investigation determined that, due to a software anomaly, a 9-grid mark overlay is incorrectly displayed during Live mode when AVVIGO+ is connected to an OptiCross 18 Peripheral Imaging Catheter. Note that the correct overlay display for this catheter is the 15-grid mark overlay, which allows for a reference depth setting of 14.9mm for peripheral catheters. This software anomaly is limited to Live or Record mode. In Review mode, the correct 15-grid mark overlay is displayed, and the vessel image is correctly scaled to the appropriate size.
Chrysler (FCA US, LLC) is recalling certain 2019, 2021-2024 Ram 1500 vehicles. Due to a software malfunction, the anti-lock brake system (ABS) control module may disable the electronic stability control system. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 126, "Electronic Stability Control Systems."
Chrysler (FCA US, LLC) is recalling certain MOPAR anti-lock braking system (ABS) control modules, used as replacement parts in certain 2019, 2021-2024 Ram 1500 vehicles. Please see the recall report for the complete list of part numbers. Due to a software malfunction, the ABS control module may disable the electronic stability control system. As such, these ABS control modules fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 126, "Electronic Stability Control Systems."
Chrysler (FCA US, LLC) is recalling certain 2020-2024 Jeep Gladiator and 2018-2024 Jeep Wrangler vehicles. The instrument panel cluster may experience an internal short circuit and fail. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 101, "Controls and Displays."
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Felling Trailers, Inc. (Felling Trailers) is recalling certain 2011-2022 Avtron D40548 trailers. The axle bracket may experience cracking and break, allowing the axle to detach from the trailer.
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
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It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Volkswagen Group of America, Inc. (Volkswagen) is recalling certain 2021-2024 ID.4 vehicles. The door handles may allow water to enter the circuit board assembly, which can cause the doors to open unexpectedly.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
The internal power connections at the power inlet of the ultrasound devices can come loose resulting in the potential for excessive heat which could lead to a thermal event or the device becoming inoperable.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
As part of our post market surveillance, we recognized that some customers are using flammable freezing sprays within the cryostat chamber. All flammable freezing sprays can potentially ignite and therefore can cause serious injuries. The flammability is indicated on the labelling of these sprays. The cryostat labelling, however, did not include any specific warning about usage of flammable freezing sprays prior to 2019.
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.