State
73,388 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.
Of the 3,571 recalls naming Montana we have scored against our rubric, 689 (19%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 952 (27%) are Severe.
Which agencies issued them
These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,388 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Abbott Vascular recalls 14,544 Dragonfly OpStar Imaging Catheters due to potential separation of the proximal marker. The affected devices were distributed throughout the US and internationally.
Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.
Beckman Coulter is recalling DxM 1096 MicroScan WalkAway Instruments because some units may have an incorrect AC power entry connector rated at 1 ampere instead of 10 amperes, posing a potential electrical safety risk.
Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.
Beckman Coulter is recalling four MicroScan WalkAway-96 Plus systems that may have been assembled with a power connector rated at 1 ampere instead of the correct 10 amperes, creating an electrical hazard risk.
Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.
Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.
Pfizer is recalling Accupril (Quinapril HCl) 20 mg tablets nationwide and in Puerto Rico due to N-nitrosoquinapril levels exceeding acceptable limits. Affected lots include DX8682 and DG1188.
Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.
Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.
Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.
The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.
Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.
Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.
Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.
Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.
Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.
Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.
Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.
Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.
Boston Scientific is updating instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation during use and provide best clinical practices for insertion, advancement, and removal.
American Health Packaging is recalling Nitrofurantoin Capsules 100 mg due to dissolution failure. The drug release results were above specification. No illnesses have been reported.
Boston Scientific updated instructions for the EXALT Model D Single-Use Duodenoscope to address the known risk of duodenal perforation and provide best clinical practices for proper insertion, advancement, and removal of the device.
Apotex Corp. recalls Sirolimus Oral Solution lot RZ1598 for exceeding dissolution specifications at the 14-month timepoint. Approximately 2,353 bottles were distributed nationwide.
Pfizer is recalling 2,079 bottles of Accupril (Quinapril HCl) 10 mg tablets due to N-nitrosoquinapril exceeding acceptable limits. The affected lot was distributed nationwide and in Puerto Rico.