State
72,992 recalls have nationwide distribution and so reach Montana. 3,568 additional recalls listed Montana specifically in their distribution scope.
Of the 3,568 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 783 (22%) are Severe.
Which agencies issued them
These figures cover only the 3,568 recalls whose distribution notice names Montana specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
Karl Storz ureteroscopes are being recalled because their instructions contain reprocessing procedures that have not been reviewed or approved by the FDA. The recall affects 3,069 units distributed nationwide.
Boston Scientific's AXIOS Stent Delivery System (47 units affected) is recalled because the outer sheath can detach and prevent proper stent expansion, requiring device exchange.
LivaNova's SenTiva DUO vagus nerve stimulation device may stop delivering therapy due to an internal component issue. The recall affects 84 units distributed worldwide.
Medline has recalled 749 procedure kits containing surgical masks that failed to meet bioburden testing standards under EN 14683. The affected kits were distributed nationwide.
Duloxetine Delayed-Release Capsules USP 20 mg are being recalled nationwide due to presence of nitrosamine impurity above FDA acceptable limits. No adverse events have been reported.
Karl Storz is recalling 65 Uretero-Renoscope units because the instructions contain reprocessing procedures that have not been FDA-reviewed or approved.
The AXIOS Stent with Electrocautery-Enhanced Delivery System may have a defective outer sheath that can detach and prevent proper stent expansion, requiring device replacement during the procedure.
The FDA is recalling approximately 33,589 BD Pyxis MedStation automated dispensing cabinets due to door latch assembly failures that may leave doors open, potentially delaying medication access and enabling medication diversion.
The muRata Vios Monitoring System Model 2050 bedside cardiac monitor has been recalled due to a software issue causing patient vital signs and ECG waveforms to flicker and become distorted on the Central Station Monitor. No injuries have been reported.
Boston Scientific is recalling AXIOS Stent devices due to outer sheath distal tip detachment that can prevent proper stent expansion and require device replacement during the procedure.
Boston Scientific is recalling 38 units of AXIOS Stent and Delivery System (15mmx10mm) because the outer sheath's distal tip may detach, preventing proper stent expansion and requiring device replacement.
Karl Storz ureteroscopes contain reprocessing instructions that have not been reviewed and approved by the FDA. Affected devices should not be reprocessed using unapproved methods.
LivaNova is recalling approximately 8,223 SenTiva VNS Therapy generators due to a potential internal component failure that may cause the implanted device to stop delivering seizure therapy. Affected patients should contact their physician.
Karl Storz Endoscopy has recalled the KARL STORZ ENDOSKOPE Uretero-Renoscope nationwide because its instructions for use contain reprocessing procedures that lack FDA review and approval for safety and efficacy.
McKesson is recalling Inflectra (infliximab-dyyb) injectable drug due to manufacturing quality deviations. A batch intended for quarantine was inadvertently distributed to patients nationwide.
Boston Scientific is recalling HOT AXIOS Stent systems due to potential outer sheath detachment that can prevent proper stent expansion. This defect may require device replacement during the procedure.
Snap rings may detach from internal shafts in CyberKnife Treatment Delivery Systems, potentially causing uncontrolled rotation on treatment axes. This affects 212 units distributed worldwide for stereotactic radiosurgery.
Boston Scientific is recalling HOT AXIOS Stent systems because the outer sheath's tip can detach and prevent proper stent expansion, requiring device replacement during procedures.
Boston Scientific's HOT AXIOS stent delivery system may have an outer sheath that detaches and prevents proper stent expansion. The defective tip can remain around the stent, requiring device exchange during the procedure.
Medline SHORT TERM INFUSAPORT ACCESS KIT with reorder number DYNDC3188 is recalled because included surgical masks failed bioburden testing, potentially compromising sterility during procedures.
Karl Storz Endoscopy is recalling its Pediatric Uretero-Renoscope 7.3 Fr. due to unapproved reprocessing instructions. The device instructions contain procedures not reviewed or approved by the FDA for safety and efficacy.
Instrumentation Laboratory recalls HemosIL Heparin Calibrators worldwide due to quality control failures. The diagnostic controls did not meet expected performance standards, potentially affecting accuracy of heparin testing in clinical laboratories.
Karl Storz is recalling its Ureteroscope (Model 27001K) because the Instructions for Use contain reprocessing procedures that have not been reviewed or approved by the FDA. All 185 units distributed nationwide are affected.
The AXIOS Stent and Delivery System is being recalled because the outer sheath can detach and prevent proper stent expansion, requiring device replacement during the procedure.
Medtronic is recalling sterile percutaneous reference pins used in image-guided surgery because the pins may not fit into the patient reference frame or adapter, potentially affecting proper surgical tracking.