State

Illinois product recalls

72,913 recalls have nationwide distribution and so reach Illinois. 11,602 additional recalls listed Illinois specifically in their distribution scope.

What the numbers show

Total: 11,602
Critical: 2,039
Severe: 2,515
Most recent: 2026-09-09

Of the 11,602 recalls naming Illinois we have scored against our rubric, 2,039 (18%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2,515 (22%) are Severe.

Which agencies issued them

These figures cover only the 11,602 recalls whose distribution notice names Illinois specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

1951–1975 of 84515

HighFDA (Devices)·Z-2164-2026·2026-05-20
Dexcom G7 app defect may delay glucose readings and alerts
Dexcom G7 CGM iOS and watchOS app versions 2.9.0 through 2.11.2 are being corrected because a software defect can delay glucose value and alert processing.
Product
Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 CGM watchOS App Model/Catalog Number: SW13355 Software Version: Versions 2.9.0 through 2.11.2 Product Description: Dexcom G7 CGM watchOS App - The watchOS app is installed along with the iOS ph
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
ModerateFDA (Devices)·Z-2153-2026·2026-05-20
Revolution CT ES X-ray Computed Tomography System Security Vulnerability Recall
GE Medical Systems is recalling Revolution CT ES and related CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link based CT Smart Subscription. The vulnerability may affect system security.
Product
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0547-2026·2026-05-20
Metoprolol Succinate Extended-Release Tablets Recalled Due to Failed Dissolution
Ascend Laboratories is recalling 17,304 bottles of Metoprolol Succinate Extended-Release 25 mg tablets (Lot #25140859, expiring Jan 2027) distributed nationwide because the tablets failed dissolution specifications, which may affect drug effectiveness.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
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
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-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-2168-2026·2026-05-20
Hologic 3DIMENSIONS MAMMOGRAPHY SYSTEM medical device recall
Hologic is recalling certain 3DIMENSIONS MAMMOGRAPHY SYSTEM models due to internal bolts that may become loose, missing, or broken over time. The FDA classified this as a Class II recall.
Product
3DIMENSIONS MAMMOGRAPHY SYSTEM; Model Numbers: 3DM-SYS-INTL2D, 3DM-SYS-INTL2D-MOB, 3DM-SYS-INTL2D-NS, 3DM-SYS-INTL3D, 3DM-SYS-INTL3D-MOB, 3DM-SYS-INTL3D-NS, 3DM-SYS-STD, 3DM-SYS-STD-MOB, 3DM-SYS-STD-NS.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2135-2026·2026-05-20
DonJoy IceMan CLASSIC3 Cold Therapy Unit Connector Defect
DJO, LLC is recalling the DONJOY IceMan CLASSIC3 cold therapy unit (Model 11-1422) due to a broken connector that may interrupt prescribed cold therapy treatment.
Product
Brand Name: DONJOY Product Name: ICEMAN W/,UNIV,LOOP,NS,RH Model/Catalog Number: 11-1422 Software Version: no Product Description: 11-1422 - ICEMAN W/,UNIV,LOOP,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-2155-2026·2026-05-20
Revolution Apex Select CT systems subject to software security vulnerability recall
GE HealthCare is recalling Revolution Apex Select and related CT systems due to a security vulnerability in the AW Server software deployed via Edison Health Link-based CT Smart Subscription.
Product
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2172-2026·2026-05-20
Edwards EVOQUE Tricuspid Delivery System Labeling Update for Valve Functionality
Edwards Lifesciences is updating labeling for the Edwards EVOQUE tricuspid delivery system (REF 9850TDS) to provide a warning if valve replacement delivery system functionality becomes compromised.
Product
Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EO
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2173-2026·2026-05-20
Codman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
Integra LifeSciences is recalling Codman CerebroFlo EVD Catheters (Lot 45322) because endotoxin levels did not meet acceptance criteria. The product was distributed nationwide.
Product
Codman CerebroFlo EVD Catheter with Endexo Technology. Contains 5 sets. Product ID: 37.550.501. The CerebroFlo EVD Catheter is a 3.3 mm diameter (10 Fr.), 35 cm long polyurethane catheter for diverting cerebrospinal fluid (CSF) from the ventricles of the brain through a series
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2166-2026·2026-05-20
Thermedx FluidSmart Urology Tube Set recalled for nonconforming products
Stryker Corporation is recalling the Thermedx FluidSmart Urology Tube Set (Catalog No. LL0006) due to nonconforming products that were inadvertently distributed. The affected tube sets were distributed nationwide in Georgia.
Product
Thermedx FluidSmart Urology Tube Set REF LL0006 UDI-DI code: 00860936000365 The FluidSmart Tube Sets are intended to be used with the FluidSmart Fluid Management System, which is intended for irrigation and fluid warming in laparoscopic procedures, and distention, fluid warmi
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 (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-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-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-2195-2026·2026-05-20
Daig Livewire Steerable Electrophysiology Catheter Incomplete Seals Recall
Stryker Sustainability Solutions is recalling 206 units of Daig Livewire Steerable reprocessed electrophysiology catheters due to incomplete seals on sterile product. The catheters were distributed nationwide and in Israel and Canada.
Product
Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2152-2026·2026-05-20
Revolution Apex Plus CT System Security Vulnerability Recall
GE HealthCare is recalling Revolution Apex Plus X-ray CT systems due to a potential security vulnerability in the AW Server deployed via Edison Health Link. Eleven units are affected worldwide.
Product
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
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-2190-2026·2026-05-20
Reprocessed Electrophysiology Catheter with Incomplete Sterile Seals
Stryker Sustainability Solutions is recalling reprocessed electrophysiology catheters due to incomplete seals on the sterile product packaging, which may compromise sterility.
Product
Daig Livewire Steerable, Product Number 401652; REPROCESSED ELECTROPHYSIOLOGY CATHETER
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-2149-2026·2026-05-20
Revolution Ascend CT scanner security vulnerability affecting AW Server
GE HealthCare is recalling Revolution Ascend computed tomography systems due to a potential security vulnerability in the AW Server used with Edison Health Link-based CT Smart Subscription. 25 units are affected nationwide.
Product
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Category
Medical Device
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