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All product recalls affecting Maryland.
Includes nationwide recalls (tagged “Nationwide”) and recalls with Maryland in the distribution area.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
The product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to generate an incorrect APO B patient result which could exceed the total allowable error for the APO B assay (11.6%). The error results in results with a positive bias up to 42%. However, based on the mitigating factors the risk to health is considered to be negligible or limited.
A new software update (v1.20) is introducing error codes for the Dxl 9000 which prevents the assay from being performed and a delay in results from being generated, and may require field service to resolve the delay.
Potential breach of sterile barrier packaging.
Potential breach of sterile barrier packaging.
Product contains undeclared sulfites (7.49mg/serving)
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Ford Motor Company (Ford) is recalling certain 2023 F-150 Lightning vehicles. The fasteners that secure the junction box bus bars inside the high-voltage battery pack may not have been tightened securely, which can cause electrical arcing at the busbars.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
cGMP deviations and lack of assurance of sterility.
Ford Motor Company (Ford) is recalling certain 2025 F-150 vehicles. The air bag warning label may be missing from the dashboard. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard number 208, "Occupant Crash Protection."
Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device will momentarily activate but will not cut or staple tissue, and additional steps will be required to open it and remove it from tissue. If user is unable to remove the device from the tissue, potential harms to patient include surgical delay, bleeding/hemorrhage, life threatening hemorrhage/hemorrhagic shock, and conversion to open therapy. Two adverse events received, including one patient death.
Internal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The Maximum Dose Limit is set in the LifeShield Drug Library Manager (DLM) within the LifeShield Medication Management Safety Software and specifies the highest dose at which the pump can be programmed for weight or BSA (body surface area) based medication rulesets. The limit can be configured for Dose, Loading Dose, and Bolus Dose.
Affected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with inadequate welds may break or separate.
Software issue with scanning equipment that can results in the filed rotation not being applied correctly.
Shyft Group (Shyft) is recalling certain 2022-2025 Utilimaster Aeromaster Upfit vehicles. The suspension seat mounting fasteners may have been improperly tightened. As such, these vehicles fail to comply with the requirements of Federal Motor Vehicle Safety Standard (FMVSS) number 207, "Seating Systems."
International Motors, LLC (International) is recalling certain 2025-2026 IC CESB and 2025 EVSB school buses. The driver's seat belt anchor bolt may come loose.