State

Montana product recalls

72,968 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 72,968 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5526–5550 of 76536

ModerateFDA (Devices)·Z-2477-2025·2025-09-03
Medication dispensing stations recalled because antivirus software was not consistently installed
BD Pyxis MedStation and Anesthesia Station devices are recalled because antivirus software was not consistently installed during implementation. 8,353 devices are affected, 6,738 of them in the US.
Product
BD Pyxis Product Name / UDI-DI code / Catalog No. BD Pyxis" MedStation" 4000 Main / 10885403512629 / 303 BD Pyxis" MedStation" ES Tower / 10885403512674 / 352 BD Pyxis" Anesthesia Station ES / 10885403477836 / 327 BD Pyxis" MedStation" ES (Main) / 10885403512667 / 323
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0596-2025·2025-09-03
Acetaminophen injection containers recalled after discoloration found in one lot
Baxter Acetaminophen Injection 1000 mg/100 mL in Viaflo containers, lot 24A27G66, is recalled nationwide because of discoloration. 13,000 containers are affected.
Product
ACETAMINOPHEN — ACETAMINOPHEN (ACETAMINOPHEN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2473-2025·2025-09-03
Coagulation analyzers recalled over potential reagent contamination in anti-Xa testing
STA Satellite analyzers are recalled because of the potential for contamination of STA-LIQUID ANTI-Xa by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 3,650 units are affected.
Product
STA Satellite. Product Code: All references. All software versions. The STA Satellite is a fully automated benchtop analyzer capable of simultaneously performing clotting, chromogenic, and immunologic assays.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2416-2025·2025-09-03
NovoTHOR light therapy devices recalled over welded nut that may shear
NovoTHOR devices, model S2188, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 80 units are affected.
Product
Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature fo
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2475-2025·2025-09-03
Anti-Xa test kits recalled over potential contamination by fibrinogen reagents
STA-Liquid Anti-Xa 8 kits are recalled because of the potential for contamination by Stago Fibrinogen reagents in unfractionated and low molecular weight heparin applications. 126,200 units are affected.
Product
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are intended for use with STA-R, STA Compact and STA Satellite analyzers, for the quantitative determination of the plasma levels of unfractionated (UFH) and low molecular weight (LMWH) heparin
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2417-2025·2025-09-03
NovoTHOR XL devices recalled over failed welded nut detaching gas strut
NovoTHOR XL devices, model S2190, are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift. 55 units are affected.
Product
Brand Name: THOR Product Name: NovoTHOR XL Model/Catalog Number: S2190 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissue temperature
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2421-2025·2025-09-03
Dental implant locating kits recalled over thread defect limiting full engagement
Atlantis IO FLO-S Kits are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 102 units are affected.
Product
Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04B / 68020033 Software Version: n/a Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure wit
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2418-2025·2025-09-03
NovoTHOR Gen 3.0 unit recalled because gas strut may detach from canopy
A single NovoTHOR Gen 3.0 Reg PRX unit, model S2189, is recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2189 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2422-2025·2025-09-03
Atlantis IO FLO-S kits recalled over thread defect limiting implant engagement
Atlantis IO FLO-S Kits, catalog A04S / 68020034, are recalled because a thread defect stops the device fully engaging an implant or analog, engaging about two rotations instead of five. 780 units are affected.
Product
Brand Name: Atlantis IO FLO Product Name: Atlantis IO FLO-S Kit Model/Catalog Number: A04S / 6802034 Product Description: The Atlantis intraoral feature locating object for suprastructures (IO FLO-S) is intended to support the prosthetic procedure with the aim of restoring che
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2419-2025·2025-09-03
Light therapy devices recalled over welded nut that may shear off
Two NovoTHOR Gen 3.0 Reg PRX units are recalled because a failed welded nut may shear off, detaching a gas strut from the canopy and making the canopy difficult to lift.
Product
Brand Name: THOR Product Name: NovoTHOR Gen 3.0 Reg PRX Model/Catalog Number: S2186 Software Version: N/A Product Description: The NovoTHOR and NovoTHOR XL are intended to emit energy in the visible and IR spectrum to provide topical heating for the purpose of elevating tissu
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2351-2025·2025-09-03
C10-4ec ultrasound transducer probes recalled to add useful life labelling
C10-4ec Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
C10-4ec Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2380-2025·2025-09-03
L18-5 ultrasound transducer probes recalled to add useful life labelling
L18-5 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
L18-5 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2389-2025·2025-09-03
S12-4 transducer probes recalled to clarify useful life in the field
S12-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S12-4 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2375-2025·2025-09-03
L12-5 38mm transducer probes recalled to add useful life labelling
L12-5 38mm Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
L12-5 38mm Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2347-2025·2025-09-03
3D9-3v ultrasound transducer probes recalled for useful life labelling clarification
3D9-3v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
3D9-3v Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2348-2025·2025-09-03
7.5 MHz Endo transducer probes recalled to clarify useful life labelling
The 7.5 MHz Endo Transducer Probe is the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
7.5MHZ Endo Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2358-2025·2025-09-03
C8-4v ultrasound transducer probes recalled to add useful life labelling
C8-4v Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
C8-4v Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2383-2025·2025-09-03
mC12-3 ultrasound probes recalled for labelling defining device useful life
mC12-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
mC12-3 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2400-2025·2025-09-03
L7-4 HDI transducer probes recalled to clarify device useful life
SCNHD LA L7-4 HDI Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
SCNHD LA L7-4 HDI Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2381-2025·2025-09-03
L8-4 transducer probes recalled to add field useful life labelling
L8-4 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
L8-4 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2398-2025·2025-09-03
S8-3t ultrasound probes recalled for labelling defining device useful life
S8-3t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S8-3t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2388-2025·2025-09-03
OMNI III TEE transducer probes recalled to add useful life labelling
OMNI III TEE Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
OMNI III TEE Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2397-2025·2025-09-03
S8-3 ultrasound probes recalled to add field useful life labelling
S8-3 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S8-3 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2412-2025·2025-09-03
X7-2t transducer probes recalled to add useful life labelling information
X7-2t Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
X7-2t Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide
LowFDA (Devices)·Z-2391-2025·2025-09-03
S4-1 transducer probes recalled for useful life labelling in the field
S4-1 Transducer Probes are the subject of a recall issued to provide clarification and labelling defining the useful life of ultrasound transducers in the field.
Product
S4-1 Transducer Probe
Category
Medical Device
Distribution
Distributed nationwide