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.

326–350 of 76387

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-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
HighFDA (Devices)·Z-2865-2026·2026-08-12
Stryker Single Spike Tube Set Recalled for Leaking During Use
Stryker is recalling 11,857 Single Spike Tube Sets due to reports of leaking from the handpiece during use.
Product
STRYKER PKG., SINGLE SPIKE TUBE SET, Catalog Number 0250070530
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2886-2026·2026-08-12
United Orthopedic Corp. Recalls Femoral Valgus Offset Adaptors for U2 Total Knee System
United Orthopedic Corp. is recalling specific femoral valgus offset adaptors used in the U2 Total Knee System due to a manufacturing defect in a component screw.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus offset adaptor, 2mm, 4mm, 6mm, left and Femoral valgus offset adaptor, 2mm, 4mm, 6mm, right Model/Catalog Number: 9323-5335, 9323-5337, 9323-5339 and 9323-5336, 9323-5338, 9323-5340 Software Version: N/A Product De
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2846-2026·2026-08-12
Quantum Rehab Q6 Edge 2.0 Power Wheelchair Recall
Pride Mobility is recalling 1,102 Q6 Edge 2.0 power wheelchairs due to a software issue that may cause unexpected braking or control system crashes during use.
Product
Brand Name: Quantum rehab Product Name: Q6 Edge 2.0 Model/Catalog Number: Q6 Edge 2.0 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-2906-2026·2026-08-12
COAPTIUM CONNECT Peripheral Nerve Repair Device Recall for Shelf Life Labeling
TISSIUM SA recalls COAPTIUM CONNECT nerve repair devices due to unvalidated 36-month shelf life labeling. Revised 26-month label will be applied. Device breakage beyond validated shelf life may require revision surgery.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO4010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighNHTSA·26E056000·2026-08-12
Odyne Recalls Hybrid Systems Due to Traction Battery Fire Risk
Odyne Systems is recalling certain hybrid systems with specific part numbers because the high-voltage batteries may fail, increasing the risk of a fire.
Product
ELECTRICAL SYSTEM:PROPULSION SYSTEM:TRACTION BATTERY recall
Category
Vehicle
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2903-2026·2026-08-12
Tissium Peripheral Nerve Repair Device Shelf Life Recall
Tissium SA is recalling the COAPTIUM CONNECT peripheral nerve repair device due to an unsubstantiated 36-month shelf life; devices will be relabeled to a validated 26-month shelf life.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO2010 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2863-2026·2026-08-12
Stryker Ahto Tube Set Recalled for Handpiece Leaking During Use
Stryker is recalling 41,052 Ahto Tube Sets worldwide due to reports of handpiece leaking during use.
Product
STRYKER AHTO TUBE SET WITH TIP PACKAGING, Catalog Number 0250070620
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2902-2026·2026-08-12
Peripheral Nerve Repair Device Relabeled Due to Unsubstantiated Shelf Life
Tissium SA is relabeling COAPTIUM CONNECT nerve repair devices because the 36-month shelf life is not supported by real-time data. The revised shelf life is 26 months.
Product
Brand Name: COAPTIUM CONNECT Product Name: COAPTIUM CONNECT Model/Catalog Number: NCOCO1575 Software Version: N/A Product Description: In situ polymerizing peripheral nerve repair device Component: No
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-2851-2026·2026-08-12
Quantum 4Front 2HD Powered Wheelchair Recall Due to Potential Safety Issues
A recall has been issued for the Quantum 4Front 2HD powered wheelchair because its controller software may cause unexpected braking or system failure that could lead to falls or injury.
Product
Brand Name: Quantum Rehab Product Name: Quantum 4Front 2HD Model/Catalog Number: Quantum 4Front 2HD 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-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-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-2885-2026·2026-08-12
U2 Total Knee System Femoral Valgus Adaptor Recall
United Orthopedic Corp. is recalling its U2 Total Knee System femoral valgus adaptors due to a manufacturing defect that prevents proper assembly of the stem component during surgery.
Product
Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334 Software Version: N/A Product Description: Manual Orthopedic Surgical Instrument Component: No
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2839-2026·2026-08-12
Biopsy Forceps Recall: Sterile Packaging Breach Risk
Boston Scientific is recalling Radial Jaw 4 Large Capacity Biopsy Forceps due to a potential breach in the sterile barrier of device packaging, which could compromise sterility.
Product
Radial Jaw 4 Large Capacity Biopsy Forceps with the following descriptions and UPN: 1. Radial Jaw 4 LC 240cm Box 20; Outer Box UPN: M00513321; Inner Box UPN: M00513320. 2. Radial Jaw 4 LC 240cm Box 40; Outer Box UPN: M00513322; Inner Box UPN: M00513320. 3. Radial J
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2849-2026·2026-08-12
Quantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
Pride Mobility Products Corp. is recalling the Quantum Rehab Q6 Edge 3 powered wheelchair controller due to a software issue that can cause unexpected braking and potential injury.
Product
Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Model/Catalog Number: Q6 Edge 3 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-2911-2026·2026-08-12
Neuroguard IEP Carotid Stent and Balloon System Recalled for Filter Failure Risk
Contego Medical, Inc is recalling Neuroguard IEP Carotid Stent and Post-Dilation Balloon Systems due to a potential filter failure issue.
Product
Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System), REF: NG-0630-140-2, NG-0640-140-2, NG-0730-140-2, NG-0740-140-2, NG-NV-6-30, NG-NV-6-40, NG-NV-7-30, NG-NV-7-40
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-2836-2026·2026-08-12
FORWARD Oral Airway Kit Recall for Potential Airway Obstruction
Integrated Medcraft LLC recalls FORWARD Oral Airway Kits due to potential occlusion of the airway tip, which could impede breathing in medical settings.
Product
FORWARD Oral Airway Kit (OPA Sizes 5, 6.5, 7, 8, 9, 10, 12). REF Number: 1011-40002. Containing the affected One-piece Guedel airway components: 1. Size 00, ISO 5.0, blue. Product Code: 1100050. 2. Size 000, ISO 3.5, light green. Product Code: 1000035.
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
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-2883-2026·2026-08-12
Knee Prosthesis Trial Recall for Manufacturing Defect
United Orthopedic Corp. recalls U2 Total Knee System PSA Box Trial due to a manufacturing defect in a component screw that prevents proper assembly of the stem trial.
Product
Brand Name: U2 Total Knee System Product Name: PSA Box Trial, L, #1-6 and PSA Box Trial, R, #1-6 Model/Catalog Number: 9323-5511 thru 9323-5516 and 9323-5521 thru 9323-5526 Software Version: N/A Product Description: Knee femur prosthesis trial, reusable Component: No, N/A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2844-2026·2026-08-12
Quantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
Pride Mobility Products Corp. is recalling Quantum Rehab R-TRAK powered wheelchairs due to a software issue that can cause unexpected braking or system crashes.
Product
Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK 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-2861-2026·2026-08-12
DASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
Nuclein LLC is recalling the DASH Rapid PCR Instrument (Model SG-0002) because a software issue may result in false co-infection readings.
Product
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2 Product Description: The DASH¿ Rapid PCR Instrument (DASH Instrument) is an automated, fluorescence-based, reverse-transcription polymerase chai
Category
Medical Device
Distribution
Distributed nationwide