State
73,104 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 785 (22%) are Severe.
Which agencies issued them
These figures cover only the 3,571 recalls whose distribution notice names Montana specifically. The 73,104 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
OptumHealth Care Solutions LLC is recalling 208 units of the Optum Nimbus II Plus ambulatory infusion pump distributed nationwide due to potential battery failure, system errors, and drug leakage.
Sammy's Milk Goat Milk Toddler Formula is recalled because the manufacturer made false claims it was safe for infants as a sole nutrition source. The product lacks FDA premarket approval and does not meet infant formula manufacturing standards.
Merit Medical Systems is recalling 18 units of Prelude Guide Sheath Roadster due to sheaths labeled as .018 dilators potentially containing .038 dilators instead. The mismatch poses a risk if the wrong-sized component is used during medical procedures.
Cadwell Industries is recalling the Cascade IOMAX Cortical Module because an incorrectly installed insulator could cause electrical arcing and potential patient shock.
A Philips Achieva 3.0T for PET MR diagnostic system (Serial 43006) may have a loose mains distribution unit terminal that could overheat and cause smoke or fire.
Philips is recalling MR RT Upgrades Magnetic Resonance diagnostic systems due to a loose terminal connection in the mains distribution unit that could cause smoke or fire. Two units with serial numbers 70980 and 71569 are affected worldwide.
Unreleased software in Scopis ENT surgical navigation systems causes visual guidance to display inaccurately relative to physical reference points, affecting surgical precision. Affects 705 units nationwide.
Philips is recalling 10 MR System 1.5T Marlin MRI devices worldwide due to a fire and smoke hazard. A loose electrical connection in the mains distribution unit may create a hotspot that causes smoke or fire in hospital technical rooms.
MEDLINE non-sterile syringes (Model 91827) are recalled because piston sizes and configurations are outside the FDA clearance range. The manufacturer is recalling 44,800 units distributed in six U.S. states.
Integra LifeSciences is recalling 1,822 units of its Cranial Access Kit due to potential holes and tears in the sterile packaging that may compromise device sterility. The kits are used in ventriculostomy procedures.
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
Philips is recalling Ingenia 1.5T CX Magnetic Resonance systems due to a loose power distribution connection that may create a fire hazard in hospital technical rooms.
Loose terminal connections in the mains distribution unit of Philips MRI systems may create electrical hotspots that could cause smoke or fire. The company is recalling 617 affected units worldwide.
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
Philips is recalling Achieva 1.5T MR diagnostic systems worldwide due to a potential loose connection in the mains distribution unit that could create a hotspot and cause smoke or fire in hospital technical rooms.
Medline is recalling 2.1 million non-sterile syringes (Model 83081) because the piston syringe sizes and configurations exceed the FDA 510(k) clearance scope. Affected products were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Philips Incisive CT scanner systems may have a defective metal mounting box that could fracture and expel fragments during operation. Eighteen units are affected nationwide.
American Regent Inc. is recalling Vasopressin Injection nationwide because some vials are subpotent and contain out-of-specification impurities.
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
Philips is recalling 139 Ingenia 1.5T S MRI scanners due to a loose terminal connection in the power distribution unit that could create an electrical hotspot and cause smoke or fire. No injuries have been reported.
Jiangsu Shenli Medical Production Co., Ltd. is recalling Medline brand 10ML non-sterile syringes (Model 91874) because piston sizes and configurations exceed the range approved under the firm's FDA 510(k) clearance.
Philips has recalled 81 Marlin 1.5T MR diagnostic systems due to a loose g-MDU terminal connection that may create a fire hazard in hospital technical rooms.
Philips is recalling its Upgrade dStream MR system due to a potential fire hazard. A loose terminal connection in the g-MDU may create a hotspot causing smoke or fire.
Medline non-sterile syringes (Model 91858) are recalled for manufacturing outside FDA-cleared specifications. The recall covers 50,400 units distributed nationwide.
Jiangsu Shenli Medical is recalling Medline non-sterile syringes (Model 91862, Lot 63722030001) because sizes and configurations exceed FDA-cleared specifications. The recall affects 400 units distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.