State

Montana product recalls

72,971 recalls have nationwide distribution and so reach Montana. 3,568 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,568
Critical: 689
Severe: 783
Most recent: 2026-09-16

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 72,971 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

6301–6325 of 76539

SevereFDA (Drugs)·D-0465-2025·2025-06-18
Dietary Supplement Electro Buzz Recalled for Undeclared Active Pharmaceutical Ingredients
SAINI TRADE INC is recalling ELECTRO BUZZ dietary supplement (lot KT-1ST-43-01-07/2024, expiring 10/15/2026) distributed nationwide. Laboratory testing found undeclared chloropretadalafil, propoxyphenylsildenafil, and sildenafil.
Product
ELECTRO BUZZ, Dietary Supplement, 10 capsules per box, Distributed By: Health Fixer, Tempe, AZ 85288, UPC B0DK68LF6J.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0463-2025·2025-06-18
Dietary Supplement Male Ultra Recalled for Undeclared Drug Ingredients
Male Ultra dietary supplement, distributed nationwide in 3,000 boxes, has been recalled because laboratory testing found it contains undeclared pharmaceutical ingredients: propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
Product
Male Ultra, Unleash Your Force, Dietary Supplement,10 capsules per box, Distributed By; Health Fixer, Tempe, AZ 85288, UPC B0CMQ4FTHG.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1936-2025·2025-06-18
Philips SmartPath to dStream 1.5T MRI Gradient Coil Fire Risk
Philips SmartPath to dStream for 1.5T MRI systems are recalled due to potential gradient coil component failure that may produce smoke and fire, posing risks of inhalation injury, burns, asphyxia, and death.
Product
SmartPath to dStream for 1.5T¿; Product Number: 782146;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0467-2025·2025-06-18
Male Ultra Pro dietary supplement recalled for undeclared pharmaceutical ingredients
Male Ultra Pro capsules are being recalled because laboratory testing found undeclared propoxyphenylsildenafil and sildenafil. The product was marketed without an approved New Drug Application.
Product
Male Ultra Pro, Unleash Your Force 2, 10 capsules per box, Distributed by: Health Fixer Tempe AZ 85288, UPC B0CZN7C6YH.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1866-2025·2025-06-18
Z-800F Infusion System Recall Due to Unvalidated Software Versions
Zyno Medical LLC is recalling the Z-800F Infusion System because unreleased software versions were installed on distributed devices without verification or validation. This poses a risk to patients receiving intravenous infusion therapy.
Product
Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0466-2025·2025-06-18
Dietary Supplement ULTRA ARMOR Recalled for Undeclared Drug Ingredients
ULTRA ARMOR dietary supplement, distributed by Health Fixer, is recalled nationwide because it contains undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil. The product was marketed without FDA approval.
Product
ULTRA ARMOR, My Armor My Power, Dietary Supplement, 10 capsules per box, Distributed by Health Fixer, Tempe, AZ 85288, UPC B0CYJ7Y5H9.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Drugs)·D-0464-2025·2025-06-18
MALEXTRA Dietary Supplement Recalled for Undeclared Pharmaceutical Ingredients
MALEXTRA Recharge with Extra dietary supplement is being recalled nationwide because laboratory testing found undeclared pharmaceutical ingredients propoxyphenylsildenafil and sildenafil in the product.
Product
MALEXTRA, Recharge with Extra, Dietary Supplement, 10 capsules per box, Distributed by: Health Fixer, Tempe, AZ 85288, UPC B0CWKZ6ZP3.
Category
Drug
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1915-2025·2025-06-18
Covidien Newport HT70 and HT70Plus Ventilators Capacitor Failure Recall
Covidien is recalling Newport HT70 and HT70Plus ventilators due to capacitor failures that may cause the device to shut down unexpectedly or fail to alarm, risking respiratory failure and oxygen deprivation in patients.
Product
Newport HT70 Ventilator, REF: HT70M-JP-NA, HT70M-CN-NA, HT70M-ES-EU, HT70M-PT-BR, HT70M-SY-EU, HT70M-WW-EU, HT70M-WW-NA, HT70-SY-EU. Newport HT70Plus Ventilator, REF: HT70PM-ES-EU, HT70PM-ES-NA, HT70PM-JP-NA, HT70PM-PT-BR, HT70PM-SY-AS, DLHT70PM-WW-NA, HT70PM-SY-NA, HT70PM-SY-
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1867-2025·2025-06-18
Z-800W Infusion System Recalled for Unvalidated Software Installation
Zyno Medical LLC is recalling the Z-800W Infusion System because unreleased software versions were installed on devices without verification or validation.
Product
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1932-2025·2025-06-18
Philips Intera 1.5T Explorer/Nova Dual MRI Gradient Coil Fire Risk
Philips is recalling one Intera 1.5T Explorer/Nova Dual MRI system due to a gradient coil component that may overheat, produce smoke, or ignite, risking patient and operator injury.
Product
Intera 1.5T Explorer/Nova Dual Product Number: 781108;
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1972-2025·2025-06-18
BD Texium Closed System Drug Transfer Devices May Leak at Connector
BD Texium closed system drug transfer devices in multiple sizes may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, exposure to hazardous drugs, and underdosing.
Product
BD Texium: 3 mL, REF: MY8003-0006; 5 mL, REF: MY8005-0006; 10 mL, REF: MY8010-0006; 20 mL, REF: MY8020-0006; 30 mL, REF: MY8030-0006; 60 mL, REF: MY8060-0006
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-1935-2025·2025-06-18
Philips Intera Achieva 1.5T Pulsar MRI Systems Gradient Coil Fire Risk
Philips is recalling certain Intera Achieva 1.5T Pulsar MRI systems due to a potential component failure in the gradient coil that could generate smoke and/or fire, risking patient and operator injury or death.
Product
Intera Achieva 1.5T Pulsar; Product Number: 781171;
Category
Medical Device
Distribution
Distributed nationwide
SevereCPSC·25342·2025-06-18
AstroAI 4-Liter/6-Can Minifridges Recalled Due to Fire and Burn Hazards
AstroAI is recalling approximately 249,100 minifridges because the electrical switch can short circuit, causing fires and burn hazards. At least 70 incidents of smoking, burning, melting, or fire have been reported, including two fires that caused more than $360,000 in property damage.
Product
4 Liter/6 Can Minifridges
Category
Consumer Product
Distribution
Distributed nationwide
HighNHTSA·25V416000·2025-06-18
REV Recalls 2025-2026 Fleetwood and Holiday Rambler Motorhomes for Electrical Defect
REV is recalling 2025-2026 Fleetwood Altitude and Holiday Rambler Incline motorhomes because water intrusion may cause electrical components to fail, potentially disabling carbon monoxide or propane detectors.
Product
FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER ALTITUDE, INCLINE
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1971-2025·2025-06-18
BD Texium Needle-Free Syringe Recalled for Potential Leakage at Luer Interface
BD Texium Needle-Free Syringes (multiple sizes) may leak at the interface between the male luer component and needle-free connector, potentially causing treatment delays, medication underdosing, or exposure to hazardous drugs.
Product
BD Texium Needle-Free Syringe: 3 mL, REF: MY8003; 5 mL, REF: MY8005; 10 mL, REF: MY8010; 20 mL, REF: MY8020; 30 mL, REF: MY8030; 60 mL, REF: MY8060
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1927-2025·2025-06-18
EPIONE Stereotactic Device Software Bug Poses Instrument Guidance Risk
The EPIONE Model 30-0001 stereotactic device is recalled due to a software bug that may cause the robotic arm to incorrectly guide surgical instruments during CT-guided ablation procedures. Four units have been distributed in the U.S.
Product
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrument position during Computed Tomography
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1956-2025·2025-06-18
Contact Lens Insertion Solution Recalled for Potential Sterility Defect
Contamac Nutrifill Physiologic formula contact lens insertion solution is being recalled because it may lack sterility. The affected product was distributed nationwide.
Product
Contamac, Nutrifill Physiologic formula, Contact Lens Insertion solution
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1950-2025·2025-06-18
Tecfen Medical 2.2mm Slit Knife ophthalmic device sterility recall
Tecfen Medical is recalling its 2.2mm Slit Knife (Model QKN2261) due to sterility assurance concerns. The ophthalmic knife is used to create precise incisions for eye surgery.
Product
Brand Name: Tecfen Medical Product Name: 2.2mm Slit Knife, Angled Model/Catalog Number: QKN2261 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Slit knive
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1923-2025·2025-06-18
Soltive Reusable Laser Fibers Recalled for Thermal Incident Risk
Olympus Corporation of the Americas is recalling Soltive Reusable Laser Fibers due to risk of thermal incidents including smoke, sparks, burning, or unsteady flames during surgery, caused by fiber fracturing.
Product
Brand Name: Powered Laser Surgical Instrument Product Name: Soltive Reusable Laser Fibers Model/Catalog Number: TFL-FBX150R, TFL-FBX200R, TFL-FBX365R, TFL-FBX550R, TFL-FBX940R, TFL-FBX940R-JA (Japan Only), TFL-FBX365R-JA (Japan Only), TFL-FBX200BS-JA (Japan Only), TFL-FBX150R-J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1965-2025·2025-06-18
iBOT PMD Personal Mobility Device Software Update Recall
Mobius Mobility LLC is recalling 442 units of the iBOT PMD (Personal Mobility Device) with software version 01.05.24 due to a software issue that could cause the device to tip over during Balance Mode operation.
Product
iBOT PMD with software version 01.05.24. Personal Mobility Device.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1957-2025·2025-06-18
KWIK-STICK Quality Control Kit for Culture Media Swab Mix-Up
Microbiologics Inc is recalling KWIK-STICK quality control kits because products were packaged with incorrect microorganism swabs, which may lead to delayed diagnosis of patient samples in clinical laboratories.
Product
KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K, Oligella urethralis derived from ATCC¿ 17960; 0621K, Staphylococcus aureus derived from NCTC 12493
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1949-2025·2025-06-18
Tecfen Medical 15 degree Stab Knife sterility assurance recall
Tecfen Medical is recalling its 15 degree Stab Knife (Model QKN1501) due to sterility assurance concerns. The ophthalmic knife is used in eye surgeries and was distributed in the US and internationally.
Product
Brand Name: Tecfen Medical Product Name: 15 degree Stab Knife Model/Catalog Number: QKN1501 Software Version: No software Product Description: This is an ophthalmic knife (manual) that is to be sterile (gamma radiation) and packaged individually in Tyvek 1059B. Stab knives ar
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-0934-2025·2025-06-18
Instant Milk Tea Powder lacks milk allergen declaration
R&M Trading LLC is recalling Instant Milk Tea Original Flavor because the label does not declare milk, despite containing whey powder and sodium caseinate, which are milk-derived ingredients.
Product
Instant Milk Tea Original Flavor, R&M Refresher brand, B0D71YHZX4, net wt. 1lb. Product is sold in 1-pack or 3-pack. Parent ASIN #B0D728CZWS 1-pack ASIN #B0D71YHZX4 3-pack ASIN #B0D72BLQRW Label declares Ingredients: Non-Dairy Creamer (Glucose Syrup, Vegetable Oil, Whey Powder
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1962-2025·2025-06-18
Baxter Healthcare 2.5V Rechargeable Batteries for PocketScope Handles
Baxter Healthcare is recalling 2.5V rechargeable batteries for Welch Allyn PocketScope handles due to potential short circuits that can cause excessive heat and user burns.
Product
2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope handles, Product Code 72600
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1973-2025·2025-06-18
BD TEXIUM Closed Male Luer Drug Transfer Device Recall
BD TEXIUM Closed Male Luer devices may leak at the interface between the closed male luer component and needle-free connector. The leak could cause procedure delays, treatment interruptions, exposure to hazardous drugs, and underdosing of medication.
Product
BD TEXIUM CLOSED MALE LUER WITH FEMALE CAP, REF: 10012241-0500
Category
Medical Device
Distribution
Distributed nationwide