State

Montana product recalls

20,096 recalls have nationwide distribution and so reach Montana. 0 additional recalls listed Montana specifically in their distribution scope.

About recalls in Montana

Most US product recalls have nationwide distribution — the manufacturer ships into every state and the recall sweeps the same way. We include those in this listing because they affect Montana consumers even though the source notice doesn’t name the state. State-specific recalls are usually for products with regional distribution (a regional dairy, a local store brand) or where the agency was able to narrow the affected shipments to specific destinations.

If you’re checking whether a recall affects your purchase, the recall detail page lists the exact production lot codes, UPCs, and best-by dates. Match those against your package — distribution scope is a starting filter, not the final answer.

6326–6350 of 20096

HighFDA (Devices)·Z-0930-2025·2025-01-22
Medical procedure kit recall due to sterile barrier packaging breach risk
Sklar Instruments is recalling ECONO STERILE nasal procedure kits due to packaging issues that may compromise sterility. The recall affects 175 units distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2236; 2) ECONO STERILE VIENNA NSL SPEC MD STRL CS/25, Model Number 96-2237M; 3) ECONO STERILE VIENNA NSL SPEC LG STRL CS/25, Model Number 96-2238; for nasal
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0931-2025·2025-01-22
Medical Procedure Kits Recalled for Potential Sterile Barrier Breach
Sklar Instruments is recalling ECONO STERILE Curette Excavator surgical kits due to packaging issues that may compromise sterile barriers. Affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE" CURETTE EXCAVATOR STRL CS/25, Model Number 941-1320; general surgical
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0901-2025·2025-01-22
Digoxin Test Slides May Report Inaccurately Due to Hemoglobin Interference
QUIDEL ORTHO is recalling VITROS DGXN test slides because hemoglobin can interfere with digoxin measurements at lower-than-expected levels, potentially causing inaccurate test results.
Product
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products DGXN Slides Model/Catalog Number: 8343386 Software Version: Not Applicable Product Description: The VITROS DGXN Slide is a multilayered, analytical element coated on a polyester support. Digoxi
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0203-2025·2025-01-22
Prescription Drug Cardura Recalled for Specification Failures in Manufacturing
Viatris Inc is recalling Cardura (doxazosin mesylate) XL 8 mg tablets due to failed stability testing revealing out-of-specification impurity levels. Approximately 1,215 bottles distributed nationwide are affected.
Product
CARDURA — CARDURA (DOXAZOSIN MESYLATE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0925-2025·2025-01-22
ECONO STERILE ear cleaning kits recalled for packaging sterile barrier issues
Sklar Instruments is recalling ECONO STERILE medical procedure kits for ear cleaning due to packaging issues that may result in a breach of the sterile barrier. The kits have been distributed nationwide.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE" BUCK EAR CUR BL STR#0STRLCS/25, Model Number 96-2273; 2) ECONO STERILE" BILLEAU EAR LOOP MD STRL CS/25, Model Number 96-2283; for ear cleaning
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0938-2025·2025-01-22
Surgical Suction Tubes Recalled for Sterile Packaging Defects
ECONO STERILE suction tubes and surgical instruments (150 units, nationwide) are recalled for packaging defects that may breach the sterile barrier and create infection risk during medical procedures.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE YANKAUER SUCTION TUBE 8.5" C10, Model Number 96-4176; 2) ECONO STERILE YANKAUER SUCTION TUBE 11" CS10, Model Number 96-4177; 3) ECONO STERILE FRAZIER TUBE 6FR STERILE CS/25, Model Number 96-5434; 4) ECONO
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0962-2025·2025-01-22
Olympus LithoCrushV Mechanical Lithotriptor Recalled for Distal Tip Tearing Risk
Olympus Corporation recalls the LithoCrushV Single Use Mechanical Lithotriptor due to potential distal tip tearing during endoscopic procedures. The FDA Class II recall affects 989 units distributed nationwide.
Product
LithoCrushV Single Use Mechanical Lithotriptor V. Model Number: BML-V442QR-30. Single Use Mechanical Lithotriptor V used with Olympus endoscope for crushing calculi inside the bile duct.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0945-2025·2025-01-22
Gynecological Procedure Kits Recalled for Potential Sterile Barrier Packaging Defects
Sklar Instruments is recalling ECONO STERILE gynecological procedure kits due to packaging issues that may compromise the sterile barrier. The affected kits may no longer maintain their sterile condition.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE KOGAN ENDOCERV SPEC STER CS/5, Model Number 96-4142A, gynecological procedures
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0923-2025·2025-01-22
Tenaculum Forceps for da Vinci Surgical Systems Recalled Due to Pitch Cable Failures
Intuitive Surgical is recalling 8MM Tenaculum Forceps used with da Vinci X/Xi Surgical Systems due to pitch cable failures. These instruments are used for tissue manipulation and retraction during surgical procedures.
Product
8MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci X/Xi Surgical Systems in a wide variety of procedures to perform a variety of surgical tasks including manipulation and retraction of tissue.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0932-2025·2025-01-22
ECONO STERILE Nail Nippers and Tissue Nippers Recalled for Sterile Barrier Issues
Sklar Instruments is recalling ECONO STERILE nail nipper and tissue nipper kits due to packaging defects that may compromise their sterile barrier. The affected kits were distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE D/A NAIL NIPPER 5.75" STER CS5, Model Number 96-2424A; 2) ECONO STERILE TISS NIPPER 14MM CVX 5"CS/25, Model Number 96-2427; 3) ECONO STERILE NAIL NIPPER 4.5" STERILE 25, Model Number 96-2666; 4) ECONO STER
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0950-2025·2025-01-22
Strabismus Surgical Scissors Kits Recalled Due to Sterile Barrier Packaging Issues
Sklar Instruments is recalling 350 strabismus surgical scissors kits nationwide due to packaging issues that may compromise the sterile barrier.
Product
Medical procedure kits labeled as: 1) ECONO STERILE STRABIS SCISS STR 4.5"STER 50, Model Number 96-2540; 2) ECONO STERILE STRABIS SCISS CVD 4.5"STER 50, Model Number 96-2541; 3) ECONO STERILE STRABIS SCISS STR 4.5"STER 25, Model Number 96-2542; 4) ECONO STERILE STRABISM
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0934-2025·2025-01-22
ECONO STERILE Dental Cement Spatula Kits Recalled for Packaging Issues
Sklar Instruments is recalling ECONO STERILE dental cement spatulas (Model 96-2245M) due to packaging defects that may compromise the sterile barrier. The product was distributed nationwide.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE CEMENT SPATULA #24 STRL CS/25, Model Number 96-2245M, mixing utensil, dental
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0910-2025·2025-01-22
Cardinal Health Presource Aneurysm Packs recalled for potential endotoxin contamination
Cardinal Health Presource surgical kits used in aneurysm procedures may contain endotoxin contamination in non-sterile surgical strips and patties. Approximately 512,786 units distributed worldwide; no illnesses reported.
Product
Cardinal Health Presource Kits: 1 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM1; 2 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM3; 3 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM5; 4 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM6; 5 ) ANEURYSM PACK , Catalog Number: SCVHFAPBM7
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0908-2025·2025-01-22
Cardinal Health Presource Surgical Kits Recalled for Endotoxin Contamination
Cardinal Health is recalling Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. No illnesses have been reported.
Product
Cardinal Health Presource Kits: 1) KIT,PLASTIC FLAP,Catalog Number PGHDOT951; 2) KIT,ORP PLASTIC FLAP,Catalog Number PGHDOT952; 3) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT910; 4) KIT,ORP PLASTIC FLAP,Catalog Number PWHDOT911; 5) KIT,ORP PLASTIC FLAP,Catalog Number PWHD
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0961-2025·2025-01-22
VerifyNow P2Y12 Platelet Reactivity Test distributed without FDA market clearance
Accriva Diagnostics distributed the VerifyNow P2Y12 Platelet Reactivity Test (Lot WL1145) without required FDA clearance. Healthcare professionals could use the unapproved test to guide treatment decisions for P2Y12 inhibitor therapy.
Product
VerifyNow P2Y12 Platelet Reactivity Test, REF: 85064
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0909-2025·2025-01-22
Surgical Kit Recall: Potential Endotoxin Contamination in Cardinal Health Presource Kits
Cardinal Health recalls Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. Affected units were distributed in the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 1 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHH1:; 2 ) TRIPLE ENDO PACK, Catalog Number: SBAOCTEHHA:; 3 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERM5:; 4 ) RIVERSIDE SINUS ENDOSCOPY PK, Catalog Number: SEN15SERMO:; 5 ) RIVERSIDE S
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0958-2025·2025-01-22
Change Healthcare Cardiology Hemo software autosave defect recall
A software defect in Change Healthcare Cardiology Hemo software may cause clinicians to administer incorrect medications. The defect affects the autosave mechanism in affected versions.
Product
Change Healthcare Cardiology Hemo software
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0941-2025·2025-01-22
Sklar Instruments Sterile Surgical Kits Recalled for Packaging Defects
Sklar Instruments is recalling 252,865 sterile surgical kits nationwide due to packaging defects that may compromise the sterile barrier, risking instrument contamination.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE IRIS SCISS 4 1/2" CVD CASE/50,Model Number 941-0918; 2) ECONO STERILE METZENBAUM SCIS STR 9"STER C25,Model Number 941-1556; 3) ECONO STERILE MAYO SCISS STRT STRL 9" CS/25,Model Number 941-1613; 4) ECONO ST
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0913-2025·2025-01-22
Cardinal Health Presource Surgical Kits Recalled for Potential Endotoxin Contamination
Cardinal Health is recalling 512,786 Presource surgical kits due to potential endotoxin contamination in non-sterile surgical strips and patties. The kits were distributed to the US, Canada, and Saudi Arabia.
Product
Cardinal Health Presource Kits: 0 ) DESCRIPTION Catalog Number: CATALOG #; 1 ) KIT, NASAL , Catalog Number: PE23NSMEA; 2 ) KIT, NASAL , Catalog Number: PE23NSMEC; 3 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number: PE23SENLA; 4 ) KIT,SEPTOPLASTY NEW HAN , Catalog Number:
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0947-2025·2025-01-22
ECONO STERILE Gynecologic Biopsy Kits Recalled for Sterile Packaging Issues
Sklar Instruments is recalling ECONO STERILE gynecologic biopsy procedure kits because of packaging issues that may breach the sterile barrier.
Product
ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE MINI TISCH 2.3X4.2MM STER CS10, Model Number 96-4134M; 2) ECONO STERILE OVAL BIOPSY FCP 3X7MM STER10, Model Number 96-4137M; gynecologic biopsy
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0919-2025·2025-01-22
Bone Graft Putty Recalled for Polymer Hydration Issue Affecting Handling
IsoTis OrthoBiologics is recalling OsteoCove Putty and Cove Putty due to a polymer hydration defect that reduces product cohesiveness and moldability.
Product
OsteoCove Putty, 1.25cc, REF 56920013 and Cove Putty, 1.25cc REF 02-9200-01.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0927-2025·2025-01-22
Sklar Instruments Recalls ECONO STERILE Trousseau Dilator Kits for Packaging Defects
Sklar Instruments is recalling ECONO STERILE trousseau dilator kits (Model 941-0191) distributed nationwide due to packaging issues that may compromise the sterile barrier. Affected healthcare providers should stop use immediately.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE TROUSSEAU DILATOR CS/25, Model Number 941-0191 (tracheal procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0926-2025·2025-01-22
ECONO STERILE Medical Procedure Kits Recalled for Packaging Defects
Sklar Instruments is recalling ECONO STERILE medical procedure kits due to packaging issues that may compromise the sterile barrier and allow contamination.
Product
ECONO STERILE brand medical procedure kits labeled as: 1) ECONO STERILE FREER ELEV DE S/B 7.25" CS/25, Model Number 96-2483 (multiple purpose); 2) ECONO STERILE LOCKE ELEV #94 NARROW STER 25, Model Number 96-2484 (foot procedures)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0948-2025·2025-01-22
Sklar Instruments IUD Extractor Kits Recalled for Sterile Barrier Packaging Issues
Sklar Instruments is recalling ECONO STERILE IUD Extractor kits (Model 96-4146A) due to packaging defects that may compromise the sterile barrier. Nationwide distribution.
Product
ECONO STERILE medical procedure kits labeled as: ECONO STERILE IUD EXTRACTOR DBL HK 10.5"CS25, Model Number 96-4146A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-0904-2025·2025-01-22
Medtronic NanoCross Elite PTA Catheter Recall Due to Balloon Deflation
Medtronic's NanoCross Elite PTA catheters in certain lots may not deflate properly during use. The FDA is recalling 5,189 units due to potential in-vivo balloon deflation issues.
Product
Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W050020090, Size: 5MM X 20MM X 90CM; 2) AB14W050020150, Size: 5MM X 20MM X 150CM; 3) AB14W050040090, Size: 5MM X 40MM X 90CM; 4) AB14W050040150, Size: 5MM X 40MM X 150CM; 5) AB14W050060150,
Category
Medical Device
Distribution
Distributed nationwide