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Lack of Assurance of Sterility
Lack of Assurance of Sterility: Firm did not perform process validation.
Jayco, Inc. (Jayco) is recalling certain 2021-2024 Jayco Solstice LI, Swift, Terrain, Terrain LE, Entegra Coach Ethos LI, Expanse LI, Launch LE motorhomes. The battery relay contactors may become stuck in the closed position.
The potential for trocar seal disengagement when using mesh products incorrectly with the device.
A new contraindication was added to the IFU which states that Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices and Supple Peri-Guard Repair Patch should not be used in neurosurgery since the product endotoxin level may be higher than the allowable limit for cerebrospinal fluid-contacting devices.
Nissan North America, Inc. (Nissan) is recalling certain 2023 Rogue vehicles. The driver and front passenger seat belt pretensioners may have been incorrectly manufactured, which can cause the seat belts to not properly restrain occupants. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection," 209, "Seat Belt Assemblies," and 210 "Seat Belt Assembly Anchorages."
Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
Isuzu Motors Limited (Isuzu) is recalling certain 2019-2024 FTR, 2020-2024 Chevrolet LCF 6500XD, 2022-2024 FVR, and 2023-2024 Chevrolet LCF 7500XD vehicles equipped with a Mobileye Collision Warning System. The Mobileye camera cable may have been routed improperly, which can result in wiring damage and an overloaded electrical circuit.
It was found that the Care Assist mobile application (version 4.1.1 and earlier) would not play custom ringtones when iOS device screens were locked with a passcode.