State

Montana product recalls

73,092 recalls have nationwide distribution and so reach Montana. 3,571 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,571
Critical: 689
Severe: 785
Most recent: 2026-09-23

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 73,092 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

9601–9625 of 76663

HighFDA (Devices)·Z-3206-2024·2024-10-02
BARD MAGNUM Biopsy Needles Recalled Due to Packaging Damage Risk
Bard Peripheral Vascular is recalling BARD MAGNUM Disposable Core Tissue Biopsy Needles due to possible packaging damage from manufacturing that may compromise sterility.
Product
BARD MAGNUM Disposable Core Tissue Biopsy Needle REF: MN1410 MN 1420 MN1610 MN1616 MN1820 MN2010 The Magnum Biopsy System (instrument and needles) is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3245-2024·2024-10-02
FDA Recalls Surgical Instrument Handle That May Break During Use
The FDA is recalling LINK Universal Handles due to risk of material failure when first used. The surgical instrument may break during surgery, compromising patient safety.
Product
LINK Universal Handle, with quick coupling, Stainless Steel, straight, Item Number 130-394/01
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·F-1820-2024·2024-10-02
Montreal Fudge Chocolate Fudge with Nuts Recalled for Mold Contamination
Authentik Fudge is recalling Montreal Fudge brand Chocolate Fudge with Nuts due to potential mold contamination. The affected products were distributed through TJ Maxx and Marshalls locations.
Product
Montreal Fudge brand Chocolate Fudge with Nuts; 5.6oz
Category
Food
Distribution
40 states
HighFDA (Devices)·Z-3258-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug expires before labeled expiration date
Cook Biotech is recalling 3 units of Biodesign Recto-Vaginal Fistula Plug RVP-0.2 because the devices expire prior to the expiration date printed on the labeling.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46601
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3201-2024·2024-10-02
Philips MR 5300 MRI System Recalled for Loose Assembly Screws
Philips is recalling 68 MR 5300 MRI diagnostic systems worldwide because loose screws in the RF carrier assembly could block equipment movement and delay patient diagnosis.
Product
MR 5300 - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 782110
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3237-2024·2024-10-02
Medical Convenience Kit Recalled for Failed Sterilization Assurance Validation
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Product
Hand Pack, AKHD97C; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3240-2024·2024-10-02
Surgical convenience kit sterilization assurance cannot be confirmed
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
Product
Essentia MAJ Laparotomy Std Pack, ESLT53B; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3276-2024·2024-10-02
Boston Scientific Esophageal Stents Recalled for Delivery Catheter Tip Detachment
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Product
WALLFLEX ESOPHAGEAL FC 18/23-25MMX12CM-- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3203-2024·2024-10-02
MRI Diagnostic Device Screws May Loosen, Block Tabletop
Philips SmartPath to dStream 1.5T MRI devices may have loose assembly screws that could block the diagnostic tabletop and delay imaging. 32 units distributed worldwide.
Product
SmartPath to dStream for 1.5T - For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782112; 2) 781260
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3270-2024·2024-10-02
Wallflex and Agile Esophageal Stents Recalled for Catheter Tip Detachment Risk
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.
Product
WALLFLEX FC ESO STENT RMV 23X155MM- Wallflex Esophageal Partially Covered (PC) and Fully Covered (FC) Stent System Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esoph
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3204-2024·2024-10-02
MRI Diagnostic Device Loose Screws May Block Patient Tabletop
Philips SmartPath dStream MRI devices have loose screws in the RF carrier assembly that may interfere with the moving tabletop, potentially delaying diagnosis. Affected units should be inspected and repaired immediately.
Product
SmartPath to dStream for XR and 3.0T- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782113; 2) 781270; 3) 782129
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·24V737000·2024-10-02
2025 Chevrolet Equinox EV door strikers recalled for possible breakage
General Motors is recalling 2025 Chevrolet Equinox EV vehicles (along with Blazer and Blazer EV models) because door strikers may not be properly heat-treated and could break, causing doors to open unexpectedly. All affected vehicles remain in dealerships.
Product
CHEVROLET — CHEVROLET BLAZER EV, EQUINOX EV, BLAZER
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3241-2024·2024-10-02
American Contract Systems Recalls ENT Medical Convenience Kits Due to Sterilization Concerns
American Contract Systems is recalling 66 ENT medical convenience kits because humidity readings were out of specification, preventing confirmation of sterilization.
Product
ENT, COEN27N; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3200-2024·2024-10-02
MRI Scanner Loose Screws May Block Tabletop and Delay Diagnosis
The Ingenia Elition X MRI device may have loose screws that interfere with the horizontal tabletop, potentially delaying patient diagnosis and causing anxiety during extended bore exposure.
Product
Ingenia Elition X- For use as a diagnostic device to obtain cross-sectional images, spectroscopic images and/or spectra of the internal structure of the head, body or extremities, in any orientation. (REF) Numbers: 1) 782151; 2) 782119; 3) 781358; 4) 782107; 5) 78213
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3190-2024·2024-10-02
Prelude Sheath Introducer 7.5F devices recalled due to labeling error
Merit Medical Systems is recalling 1,892 Prelude Sheath Introducer devices due to a labeling error: devices labeled as 7.5F are actually sized as 7F. The dimensional mislabeling could result in incorrect device selection during medical procedures.
Product
Prelude Sheath Introducer 7.5F, REF: PSI-7F-11-038 Version F (PSI-7F-11-038/F)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3297-2024·2024-10-02
CooperSurgical Recalls Origio Sperm Wash Medium Due to Low Sodium Pyruvate
CooperSurgical is recalling Origio Sperm Wash Medium because low sodium pyruvate levels could compromise gamete development.
Product
Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3252-2024·2024-10-02
Biodesign Fistula Plug recalled for expiring before printed expiration date
Cook Biotech is recalling 35 units of Biodesign Fistula Plug surgical implants that expire before their printed expiration dates, potentially compromising device function.
Product
Biodesign Fistula Plug C-FPS-0.2 - For implantation to reinforce soft tissue for repair of recto-vaginal or anorectal fistulas. Order Number (GPN): G54612
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3272-2024·2024-10-02
Esophageal stent systems recalled due to delivery catheter tip detachment risk
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
Product
WALLFLEX FC ESO STENT RMV LL 23X105- Intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas Material Number (UPN): M00516300
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3291-2024·2024-10-02
Boston Scientific Esophageal Stent Systems Recalled for Catheter Tip Detachment Risk
Boston Scientific is recalling WallFlex and Agile Esophageal Stent Systems for potential delivery catheter tip detachment during insertion. Eighteen units were distributed worldwide including the United States.
Product
AGILE ESO OTW FC 23MM X 10.1CM IN 18.5 F-Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concu
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3231-2024·2024-10-02
Day Surgery General Pack medical kit recalled for sterilization concern
American Contract Systems recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Product
Day Surgery General Pack, FHGE18T; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3158-2024·2024-10-02
Mobile X-Ray System Exposure Settings May Not Apply Correctly
Fujifilm mobile x-ray systems may fail to apply configured exposure settings or default to adult chest imaging parameters. This could result in inappropriate radiation exposure levels.
Product
The device is a mobile x-ray system designed to work with Fujifilm's GOS and CsI scintillator FDR D-EVO2 (DR-ID) 12XXSE) family of digital x-ray detectors coupled.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3229-2024·2024-10-02
Arthroscopy Pack Recalled Due to Unconfirmed Sterilization Assurance
American Contract Systems is recalling 48 Arthroscopy Packs because humidity readings were out of specification, preventing confirmation of sterilization.
Product
Arthroscopy Pack, MSKA45A; Medical convenience kit
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3295-2024·2024-10-02
Boston Scientific Agile Esophageal Stent Recall: Catheter Tip Detachment Risk
Boston Scientific is recalling Agile Esophageal Stent Systems due to potential delivery catheter tip detachment. The Class II recall affects 6 units distributed worldwide.
Product
AGILE ESO FC RMV 23MM X 15.0CM IN 18.5 F- Agile Esophageal Partially Covered (PC) and Fully Covered (FC) OTW Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of conc
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3223-2024·2024-10-02
Karl Storz Hopkins Telescope 6 Endoscope Recalled for Unapproved Reprocessing Instructions
Karl Storz Hopkins Telescope 6 endoscopes (59 units, nationwide) are recalled because their reprocessing instructions lack FDA review and approval for safety and efficacy.
Product
Karl Storz - Endoskope , REF: 27295AA, Hopkins Telescope 6, 18 Fr, Rx only, CE 0123
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3260-2024·2024-10-02
Biodesign Recto-Vaginal Fistula Plug Recalled for Premature Expiration
Cook Biotech is recalling 8 units of Biodesign Recto-Vaginal Fistula Plug devices because they expire before the date printed on the label. The affected products may lose sterility if used after actual expiration.
Product
Biodesign Recto-Vaginal Fistula Plug RVP-0.7 - For implantation to reinforce soft tissue for repair of recto-vaginal fistulas. Order Number (GPN): G46603
Category
Medical Device
Distribution
Distributed nationwide