State

Montana product recalls

72,820 recalls have nationwide distribution and so reach Montana. 3,567 additional recalls listed Montana specifically in their distribution scope.

What the numbers show

Total: 3,567
Critical: 689
Severe: 783
Most recent: 2026-09-02

Of the 3,567 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 3,567 recalls whose distribution notice names Montana specifically. The 72,820 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

351–375 of 76387

HighFDA (Devices)·Z-2901-2026·2026-08-12
COAPTIUM Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM Connect nerve repair devices to reduce the shelf life from 36 to 26 months because the original duration was not supported by real-time data.
Product
Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect Model/Catalog Number: NCOCO1510 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2848-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Wheelchair Recall Due to Safety Risks
The FDA is recalling the Quantum Rehab Q6 Edge 2.0 powered wheelchair because its controller may cause unexpected braking or system crashes that could lead to falls and injuries.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 2.0 (ilevel) Model/Catalog Number: Q6 Edge 2.0 (ilevel) Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2841-2026·2026-08-12
Powered wheelchair controller recalled for unexpected braking hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum 4Front 2 wheelchair controllers because reminder pop-ups can trigger unexpected park brake stops while driving, causing falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Number: Quantum 4Front 2 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2907-2026·2026-08-12
Coaptium Connect Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling Coaptium Connect nerve repair devices because the current 36-month shelf life is not supported by real-time data. The shelf life is being reduced to 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO5010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2864-2026·2026-08-12
Stryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
Stryker Corporation is recalling 2,739 units of the Ahto Dual Spike Tube Set packaging due to reported handpiece leaks during use. No injuries have been reported.
Product
STRYKER AHTO DUAL SPIKE TUBE SET PACKAGING, Catalog Number 0250070640
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2878-2026·2026-08-12
GE Healthcare Portrait Core Services Software Recall Due to Software Vulnerability
GE Medical Systems Information Technologies Inc is recalling GE Healthcare Portrait Core Services SW V 1.2.0 (REF 5700592) patient monitoring systems due to a software vulnerability.
Product
GE Healthcare Portrait Core Services SW V 1.2.0, REF 5700592. patient monitoring system
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2853-2026·2026-08-12
Quantum Rival Powered Wheelchair Controller Recall for Brake Stop Hazard
Pride Mobility Products Corp. is recalling 1,102 Quantum Rival powered wheelchair controllers due to a software issue that can cause unexpected brake stops while driving, potentially resulting in falls or injuries.
Product
Brand Name: Quantum Rehab Product Name: Quantum Rival Model/Catalog Number: Quantum Rival Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2859-2026·2026-08-12
Anti-Torque Instrument in Vector Pedicle Screw System Recalled
Innovasis, Inc is recalling 5 Anti-Torque instruments (part LS-749) in the Vector Pedicle Screw System due to an undersized condition that may prevent proper engagement during spinal surgery, causing delays.
Product
Anti-Torque, Vector, Part: LS-749 part of Vector Pedicle Screw System
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2860-2026·2026-08-12
Flow Anesthesia Machines Recalled for Failure to Deliver Anesthetic Agent
The FDA is recalling Flow Anesthesia Machines because events occurred where the anesthetic agent was not delivered when the vaporizer was activated, potentially causing patients to receive insufficient anesthesia.
Product
Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i C30 6888530 Flow-i C40 6888540 Flow-c 6887700 Flow-e 6887900
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E054000·2026-08-12
Volvo Trucks Recalls Grote Replacement Marker Lights for Visibility Issues
Volvo Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2845-2026·2026-08-12
Powered Wheelchair Controller Software May Cause Unexpected Brake Stop
Pride Mobility is recalling 1,102 Q6 Edge HD powered wheelchairs due to a software issue in the controller that may cause unexpected park brake stops or system crashes when reminder pop-ups appear during use.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6 Edge HD Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2890-2026·2026-08-12
Siemens Atellica CH Urine Albumin In Vitro Diagnostic Recall
Siemens Healthcare Diagnostics is recalling Atellica CH Urine Albumin assays due to potential false results and QC failures when processed on CI analyzers.
Product
Atellica CH Urine Albumin REF: 11537225, in vitro diagnostic
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2877-2026·2026-08-12
FilmArray NGDS Warrior Panel Diagnostic Test Recalled Due to Strain Mismatch
Biofire Defense is recalling FilmArray NGDS Warrior Panel kits because the test may not correctly identify certain outbreak strains due to mismatches with the reference strain used during development.
Product
FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior Panel is a qualitative, multiplexed, nucleic acid-based in vitro diagnostic test intended for use with the FilmArray 2.0 system. The FilmArray NGDS Warrior Panel detects
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2898-2026·2026-08-12
United Orthopedic Recalls U2 Total Knee System Femoral Offset Bushings
United Orthopedic Corp. is recalling U2 Total Knee System femoral offset bushings due to incorrect engraved numbering that could cause incorrect implant orientation.
Product
Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 2mm and 6mm Model/Catalog Number: 9323-5312 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2892-2026·2026-08-12
Philips Azurion interventional fluoroscopic X-ray systems recalled for potential hardware failures
Philips Azurion X-ray systems may lose imaging capability or motor functions due to unauthorized hard drives.
Product
Philips Azurion under the following System Descriptions and corresponding model numbers: 1. Azurion 3 M12; Model Numbers: 722063, 722221. 2. Azurion 3 M15; Model Numbers: 722064, 722222, 722280. 3. Azurion 5 M12; Model Number: 722227. 4. Azurion 5 M20; Model Numbers: 7222
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2847-2026·2026-08-12
Powered Wheelchair Controller Software May Cause Unexpected Brake Stop
Pride Mobility is recalling 1,102 Quantum 1450 powered wheelchairs with controller software version 2.0.11 because reminder pop-ups can trigger an unexpected park brake stop while driving, risking falls or injury.
Product
Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: Quantum 1450 Software Version: 2.0.11, new version: 2.0.13 Product Description: Wheelchair, Powered (ITI), 890.3860 Component: Controller
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E055000·2026-08-12
Mack Recalls Grote Replacement Marker Lights for Visibility Failure
Mack Trucks is recalling certain Grote replacement marker lights that may fail to illuminate, reducing vehicle visibility and increasing crash risk.
Product
GROTE — GROTE CLEARANCE/MARKER LAMP
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2866-2026·2026-08-12
Stryker Strykeflow Suction/Irrigator PS Recalled for Leaking During Use
Stryker is recalling Strykeflow Suction/Irrigator PS devices due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., STRYKEFLOW SUCTION/IRRIGATOR PS, Catalog Number 0250070540
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2895-2026·2026-08-12
Aniara 5-PLASMA Bivalirudin Calibrator Recalled for Stability Issues
Aniara Diagnostica LLC is recalling 7 units of 5-PLASMA Bivalirudin Calibrator due to stability issues that cause degradation of measurable bivalirudin.
Product
5-PLASMA Bivalirudin Calibrator, Model Number 5D-46905
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2882-2026·2026-08-12
Happiest Baby Recalls Pre-Loved SNOO Smart Sleeper Bassinets
Happiest Baby, Inc is recalling 4 refurbished SNOO Smart Sleeper bassinets (Model S1000) that failed to meet quality standards before distribution. The recall is being reported retroactively.
Product
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2905-2026·2026-08-12
COAPTIUM CONNECT peripheral nerve repair device recalled due to inaccurate shelf life labeling
The FDA is recalling the COAPTIUM CONNECT peripheral nerve repair device because its shelf life was previously overstated, which could cause device failure during surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO3010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2896-2026·2026-08-12
5-PLASMA Bivalirudin Control Model 5D-44905 Recalled Due to Stability Issues
Aniara Diagnostica LLC is recalling 5-PLASMA Bivalirudin Control (Model 5D-44905) due to stability issues that may cause degradation of measurable bivalirudin.
Product
5-PLASMA Bivalirudin Control, Model Number 5D-44905
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2910-2026·2026-08-12
Blom-Singer Voice Prosthesis Recalled Due to Incorrect Labeling
Freudenberg Medical recalls 40 Blom-Singer Classic Indwelling Voice Prostheses due to labeling errors that could cause confusion about product contents.
Product
Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2908-2026·2026-08-12
COAPTIUM CONNECT medical device shelf life recalibration recall
TISSIUM SA is recalling COAPTIUM CONNECT devices because their original 36-month shelf life was not supported by real-time data, requiring relabeling to a 26-month shelf life to prevent potential device failure during surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO6010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0733-2026·2026-08-12
Dicyclomine Hydrochloride Capsules Recalled for Empty Capsules
Aurobindo Pharma is recalling dicyclomine hydrochloride capsules, 10mg, due to reports of empty capsules found in the product.
Product
DICYCLOMINE HYDROCHLORIDE — DICYCLOMINE HYDROCHLORIDE (DICYCLOMINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide