State

Montana product recalls

72,969 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 72,969 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

5676–5700 of 76537

CriticalFDA (Devices)·Z-2290-2025·2025-08-20
HeartMate mobile power unit cords recalled over locking feature that may disconnect
Abbott is recalling 53 HeartMate Mobile Power Unit AC power cords, model 107760, because a misaligned V-Lock may not engage and can allow an unintended disconnect. The FDA classified this as Class I.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit, AC Power Cord Model/Catalog Number: 107760 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device desi
Category
Medical Device
Distribution
Distributed nationwide
CriticalFDA (Devices)·Z-2173-2025·2025-08-20
Infusion pumps recalled over underinfusion when flow rate more than doubles
Baxter is issuing an urgent correction for 36,705 Novum IQ large volume pumps because the pump may underinfuse when moving to a flow rate more than double the current one.
Product
Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2227-2025·2025-08-20
DreamStation Auto CPAP units may hold an incorrect device configuration
DreamStation Auto CPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 57 units are affected.
Product
DreamStation Auto CPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2228-2025·2025-08-20
DreamStation Auto BiPAP units may hold an incorrect device configuration
DreamStation Auto BiPAP non-continuous ventilators are being recalled because the devices may possess a programming error resulting in an incorrect device configuration. 8 units are affected.
Product
DreamStation Auto BiPAP. Non-Continuous Ventilator.
Category
Medical Device
Distribution
Distributed nationwide
SevereNHTSA·25V533000·2025-08-20
Mercedes steering coupling bolt may loosen from the steering rack
Mercedes-Benz is recalling certain 2023-2026 EQE and GLC vehicles because the steering coupling bolt may have been improperly tightened, allowing the coupling to loosen from the steering rack.
Product
MERCEDES-BENZ — MERCEDES-BENZ EQE 500 4MATIC, EQE 350 4MATIC, AMG EQE 53 4MATIC, AMG GLC63 S E
Category
Vehicle
Distribution
Distributed nationwide
SevereUSDA FSIS·028-2025·2025-08-20
Sabrositos Hondurenos Recalls Meat Products Produced Without Federal Inspection
Sabrositos Hondurenos, LLC is recalling approximately 32,000 pounds of meat products that were produced without federal inspection and bear false USDA marks.
Product
Sabrositos Hondurenos, LLC, Recalls Various Meat Products Produced Without Benefit of Inspection
Category
Food
Distribution
Distributed nationwide
SevereNHTSA·25V532000·2025-08-20
Aston Martin Recalls 2025 Vanquish for Brake Assist Software Defect
Aston Martin is recalling 2025 Vanquish vehicles because a vacuum pump defect may cause loss of power brake assist, increasing stopping distance and crash risk.
Product
ASTON MARTIN — ASTON MARTIN VANQUISH
Category
Vehicle
Distribution
Distributed nationwide
SevereFDA (Devices)·Z-2291-2025·2025-08-20
HeartMate mobile power unit cords may disconnect from a misaligned lock
HeartMate Mobile Power Units are being recalled because misaligned V-Lock features on the power cords prevent the locking mechanism engaging properly and may cause unintended disconnect. 604 units affected.
Product
Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2322-2025·2025-08-20
Thyroglobulin assay reagent recalled after lot generated erroneously high patient results
Access Thyroglobulin assay reagent lot 439163 is recalled because it may generate erroneously high patient results, which could prompt unnecessary imaging or therapy changes. 453 units are affected.
Product
Access Thyroglobulin assay, a simultaneous one-step immunoenzymatic assay, Catalog Number 33860
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0464-2025·2025-08-20
Strawberry con crema paleta 6-packs recalled for cream without milk declaration
La Michoacana Strawberry Con Crema 6-Pack Paletas, 16.5 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 33,105 units are affected.
Product
La Michoacana Strawberry Con Crema 6-Pack Paleta 16.5oz UPC: 7-67778-00102-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2285-2025·2025-08-20
Knee tibial insert catalog number 341-16-704 recalled for mislabeled size or side
Enovis is recalling 18 EMPOWR 3D Knee tibial inserts, catalog number 341-16-704, lot 148T1057, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0425-2025·2025-08-20
Dessert dip recalled nationwide after plastic foreign material found in product
Park Street Deli Cinnamon Bun Dessert Dip in 7 oz plastic tubs is recalled nationwide for plastic foreign material. 19,368 retail units are affected.
Product
Park Street Deli Cinnamon Bun Dessert Dip Net WT 7oz. in plastic tub UPC 4061462440151
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0459-2025·2025-08-20
La Michoacana strawberry paletas list cream without declaring milk as source
La Michoacana Strawberry Con Crema Single Serve Paletas are being recalled because the label includes the ingredient cream but does not include milk as the source. 62,864 units affected.
Product
La Michoacana Strawberry Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00002-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0462-2025·2025-08-20
Cookies and cream paletas recalled because label lists cream without declaring milk
La Michoacana Cookies N Cream Single Serve Paletas, 3.75 oz, are recalled nationwide because the label names cream as an ingredient but does not declare milk as its source. 15,001 units are affected.
Product
La Michoacana Cookies N Cream Single Serve Paleta 3.75oz UPC: 7-67778-00007-5
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0471-2025·2025-08-20
Choco-dipped mini paletas recalled because label lists cream but omits milk
Helados Mexico Choco-Dipped Minis Variety Paletas, 12-count 18 oz, are recalled nationwide because the label lists cream without declaring milk as its source. 42,564 units are affected.
Product
Helados Mexico Choco-Dipped Minis Variety Paletas 12-Count 18oz UPC: 6-82082-81215-5 UPC: 6-82082-41215-7
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0576-2025·2025-08-20
Amlodipine and olmesartan tablets recalled after failing dissolution specification testing
Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, lot 23121560, are recalled nationwide for low dissolution results. The recall covers 8,568 bottles.
Product
AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0460-2025·2025-08-20
Mango con crema paletas recalled for listing cream without milk allergen declaration
La Michoacana Mango Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 24,228 units are affected.
Product
La Michoacana Mango Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00008-2
Category
Food
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0586-2025·2025-08-20
Sodium chloride injection containers recalled over potential fluid leakage at weld site
B. Braun 0.9% Sodium Chloride Injection USP, 1000 mL Excel containers, lot J5C919, is recalled for lack of assurance of sterility because of potential fluid leakage at a weld site. 23,100 containers are affected.
Product
SODIUM CHLORIDE — SODIUM CHLORIDE (SODIUM CHLORIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2286-2025·2025-08-20
EMPOWR 3D knee tibial inserts recalled over incorrect size or side labeling
Enovis is recalling 40 EMPOWR 3D Knee tibial inserts, catalog number 342-16-707, because the implants carry incorrect size or side labeling.
Product
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 7R 16MM, VE Model/Catalog Number: 342-16-707 Product Description: Enovis knee devices are intended for treatment of patients who are candidates for knee arthroplasty per the Indication for use.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0587-2025·2025-08-20
Glenmark carvedilol 12.5 mg tablets exceed the nitrosamine impurity limit
Carvedilol Tablets USP 12.5 mg from Glenmark are being recalled because N-Nitroso Carvedilol Impurity-1 was observed above the FDA-recommended limit of not more than 4.0 ppm. 17,496 bottles affected.
Product
CARVEDILOL — CARVEDILOL (CARVEDILOL)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2280-2025·2025-08-20
Cannulated fenestrated polyaxial screws recalled because they may be incorrectly labeled
PERLA TL MIS cannulated fenestrated polyaxial screws, model MPF-PS 55 45-S, lot 8-4266, are recalled because the screws may be incorrectly labeled.
Product
Brand Name: PERLA ¿ TL MIS Product Name: CANNULATED FENESTRATED POLYAXIAL SCREW Model/Catalog Number: MPF-PS 55 45-S Software Version: Not Applicable Product Description: CANNULATED FENESTRATED POLYAXIAL SCREW
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0499-2025·2025-08-20
Clover Valley instant coffee may contain glass pieces in jars
Clover Valley Instant Coffee in 8 oz glass jars is being recalled because of the potential presence of glass pieces. 84,240 units are affected.
Product
Clover Valley Instant Coffee, NET WT 8 OZ (227 g), packaged in a glass jar, packed 6 jars per case, UPC: 876941004069, Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072
Category
Food
Distribution
48 states
HighFDA (Food)·H-0458-2025·2025-08-20
Single serve coconut con crema paletas recalled for missing milk source declaration
La Michoacana Coconut Con Crema Single Serve Paletas, 3.75 oz, are recalled nationwide because the label lists cream but does not declare milk as its source. 74,654 units are affected.
Product
La Michoacana Coconut Con Crema Single Serve Paleta 3.75oz UPC: 7-67778-00001-3
Category
Food
Distribution
Distributed nationwide
HighFDA (Food)·H-0466-2025·2025-08-20
Variety paleta 16-count packs recalled over cream ingredient missing milk source
La Michoacana Variety Paletas, 16-count 44 oz packs, are recalled nationwide because the label lists cream but does not declare milk as its source. 2,241 units are affected.
Product
La Michoacana Variety Paletas 16-Count 44oz UPC:7-67778-03100-0
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2295-2025·2025-08-20
Custom manifold kit tubing may separate and trap air in line
Custom Manifold Kits are being recalled because high pressure tubing may relax over time and partially separate from the connector, creating a void that can trap air and introduce it into the patient. 6,327 units affected.
Product
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Category
Medical Device
Distribution
Distributed nationwide