The Recall Desk

State

Montana product recalls

72,913 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.

These figures cover only the 3,567 recalls whose distribution notice names Montana specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1826–1850 of 76480

  • HighFDA (Devices)·Z-2193-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Sterile Seal Defect Recall

    Stryker Sustainability Solutions is recalling three lots of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile packaging. The defect affects units distributed in the US, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401908; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2175-2026·2026-05-20

    BARD Dynamic Tip Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling BARD Dynamic Tip Steerable reprocessed electrophysiology catheters (Product Number 200131) due to incomplete seals on sterile product packaging. The recall affects 61 units distributed nationwide in the US and in Israel and Canada.

    Product
    BARD Dynamic Tip Steerable, Product Number 200131; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2165-2026·2026-05-20

    Dexcom ONE+ iOS CGM App Software Defect Delayed Glucose Alerts

    Dexcom, Inc. is recalling Dexcom ONE+ iOS CGM App versions 1.5.0 and 1.6.0 due to a software defect that can delay glucose alerts and notifications, risking delayed detection of low or high blood sugar events.

    Product
    Brand Name: Dexcom ONE+ Continuous Glucose Monitoring System Product Name: Dexcom ONE+ iOS CGM App Model/Catalog Number: SW14244 Software Version: versions 1.5.0 and 1.6.0 Product Description: Dexcom ONE+ iOS CGM App Component: Dexcom ONE+ Continuous Glucose Monitoring Syste
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2185-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recall Due to Incomplete Seals

    Stryker Sustainability Solutions is recalling 816 units of CS Uni-Directional w Auto ID reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    CS Uni-Directional w Auto ID, Product Number D135304; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2179-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic XT Steerable reprocessed electrophysiology catheters (Product Number 201103) due to incomplete seals on the sterile product packaging.

    Product
    BARD Dynamic XT Steerable, Product Number 201103, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2169-2026·2026-05-20

    QuickVue Dipstick Strep A Test Recalled for False Positive Results

    Quidel Corporation is recalling the QuickVue Dipstick Strep A Test (50T, REF 20108) due to the potential for false positive results. The product was distributed nationwide.

    Product
    QuickVue Dipstick Strep A Test, 50T, REF 20108, antigens, all groups, streptococcus spp.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2191-2026·2026-05-20

    Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable reprocessed electrophysiology catheters (Product Number 401904) due to incomplete seals on sterile product. The recall affects 1,352 units distributed across the United States, Israel, and Canada.

    Product
    Daig Livewire Steerable, Product Number 401904; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2182-2026·2026-05-20

    BARD EP XT Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling BARD EP XT Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product, which may compromise sterility. Affected units were distributed in the US, Israel, and Canada.

    Product
    BARD EP XT Steerable, Product Number 200794; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0771-2026·2026-05-20

    Dakota Honey jalapeno spun honey may contain metal or plastic pieces

    Dakota Honey Company Spreadable Spun Honey in jalapeno flavour is being recalled because of a foreign object: stainless steel dust or flakes, or shreds of plastic.

    Product
    Dakota Honey Company Spreadable Spun Honey, Jalapeno. Stir before use. Produced in Winner, SD. Packaged in the following sized plastic jars: 1. Net Wt 4 oz (113g) UPC 8 60012-41982 1. 2. Net Wt 12 oz (340g) UPC 8 60010-57965 7.
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2197-2026·2026-05-20

    Daig Livewire Steerable Reprocessed Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling 458 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    Daig Livewire Steerable, Product Number 401932; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2174-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Seals

    Stryker Sustainability Solutions is recalling BARD Dynamic Deca Steerable reprocessed electrophysiology catheters (Product Number 201101) distributed nationwide and in Israel and Canada due to incomplete seals on the sterile product packaging. The incomplete seals may compromise sterility.

    Product
    BARD Dynamic Deca Steerable, Product Number 201101; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2184-2026·2026-05-20

    Reprocessed electrophysiology catheters recalled over incomplete sterile seals

    The CS Uni-Directional with Auto ID reprocessed electrophysiology catheter is being recalled because of incomplete seals on the sterile product. 449 units are affected.

    Product
    CS Uni-Directional w Auto ID, Product Number D135303; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2198-2026·2026-05-20

    Daig Livewire Steerable BDB Electrophysiology Catheter Recall

    Stryker Sustainability Solutions is recalling Daig Livewire Steerable BDB reprocessed electrophysiology catheters due to incomplete seals on the sterile product.

    Product
    Daig Livewire Steerable BDB, Product Number 401918, REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2181-2026·2026-05-20

    Reprocessed Electrophysiology Catheter Recalled for Incomplete Sterile Seals

    Stryker Sustainability Solutions is recalling 217 units of BARD EP XT Decapolar Steerable reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging.

    Product
    BARD EP XT Decapolar Steerable, Product Number 201007; REPROCESSED ELECTROPHYSIOLOGY CATHETER
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0527-2026·2026-05-20

    Buprenorphine Hydrochloride Injection Recall Due to Particulate Matter

    Endo USA, Inc. is recalling Buprenorphine Hydrochloride injection vials distributed nationwide due to the presence of particulate matter identified as Buprenorphine free base. The FDA classified this as a Class II recall.

    Product
    BUPRENORPHINE HYDROCHLORIDE — BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2137-2026·2026-05-20

    DonJoy IceMan cold therapy unit recall due to broken connector

    DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (model 11-9099) due to a broken connector that may interrupt prescribed cold therapy. The affected unit is lot 110525, distributed across the US and Canada.

    Product
    Brand Name: DONJOY Product Name: ICEMAN, W/COLDPAD, NS, RH Model/Catalog Number: 11-9099 Software Version: No Product Description: 11-9099 - ICEMAN, W/COLDPAD, NS, RH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2136-2026·2026-05-20

    DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Fault Recall

    DJO, LLC is recalling the DonJoy IceMan CLASSIC3 cold therapy unit (Model 11-1424) due to a broken connector that may interrupt prescribed cold therapy treatment.

    Product
    Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,EH Model/Catalog Number: 11-1424 Software Version: No Product Description: 11-1424 - ICEMAN W/,UNIV,LOOP,NS,EH The IceMan CLASSIC3¿ cold therapy unit helps reduce pain and swelling, speeding up rehabilitation. The IceMa
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2151-2026·2026-05-20

    Revolution Apex Elite X-ray CT System Security Vulnerability Recall

    GE HealthCare is recalling certain Revolution Apex Elite X-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. The vulnerability may affect data security in CT Smart Subscription systems.

    Product
    Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2171-2026·2026-05-20

    ZYMUTEST HIA IgG ELISA Diagnostic Kit Recall for Incorrect Control Values

    Aniara Diagnostica LLC is recalling ZYMUTEST HIA IgG diagnostic kits (Lot FD1265) due to an outdated flyer containing incorrect positive control values that could affect test result interpretation.

    Product
    ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2162-2026·2026-05-20

    Diowave Laser System Software Update Required for Power Output Issue

    Diowave 250W Laser Systems require a software update because some units operate at up to 70W maximum average power output, exceeding the FDA-cleared limit of 60W.

    Product
    Diowave Laser System, REF: Diowave 250W
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2150-2026·2026-05-20

    Revolution CT X-ray Computed Tomography System Security Vulnerability Recall

    GE HealthCare is recalling Revolution CT x-ray computed tomography systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription. The vulnerability affects certain Revolution Apex, Revolution Ascend, and Revolution CT systems worldwide.

    Product
    Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2170-2026·2026-05-20

    Philips Azurion X-Ray System Cable Hose Carriers May Loosen or Break

    Bolts and plastic parts of cable hose carriers on Philips Azurion X-ray systems may loosen or break during monitor movement or rotation, potentially causing the cable hose to become unsecured.

    Product
    Philips Azurion. System Code Description (Model Number): Azurion 3 M12 (722221, 722229), Azurion 3 M15 (722222, 722230), Azurion 5 (722281), Azurion 5 M12 (722227, 722231), Azurion 5 M20 (722228, 722232, 722281), Azurion 7 (722282), Azurion 7 B12 (722225, 722235), Azurion 7 B20 (
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2161-2026·2026-05-20

    LUCAS Chest Compression Systems Recalled for Inadequate Service Documentation

    Jolife AB is recalling 153 LUCAS chest compression systems (Models 2, 3, and 3.1) due to incomplete service documentation. Service work performed on affected systems was not properly documented in service records.

    Product
    LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS 3 Model Number: 99576 Catalog Number: 99576-000043 UDI-DI code: 00883873861875 LUCAS 3.1 Model Number: 99576 Catalog Number: 99576-000063 UDI-DI code: 0088
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2154-2026·2026-05-20

    Revolution Apex X-ray CT System Security Vulnerability Recall

    GE HealthCare is recalling Revolution Apex, Revolution Ascend, and Revolution CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link-based CT Smart Subscription. The vulnerability may impact system security.

    Product
    Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
    Category
    Medical Device
    Distribution
    Distributed nationwide