State

Illinois product recalls

72,992 recalls have nationwide distribution and so reach Illinois. 11,607 additional recalls listed Illinois specifically in their distribution scope.

What the numbers show

Total: 11,607
Critical: 2,039
Severe: 2,517
Most recent: 2026-09-25

Of the 11,607 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 2,517 (22%) are Severe.

Which agencies issued them

These figures cover only the 11,607 recalls whose distribution notice names Illinois specifically. The 72,992 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.

7801–7825 of 84599

HighFDA (Devices)·Z-1449-2025·2025-04-02
Medline Procedure Kits With Defective Syringes Recalled Nationwide
Medline is recalling 268 procedure kits nationwide due to plastic syringes affected by a March 2024 FDA safety alert. The syringes may leak, break, or have quality issues that could affect patient care.
Product
Medline procedure kits labeled as: 1) CSMC/ABDOMINAL HYST PACK-LF, Pack Number DYNJ0665086F; 2) MAJOR VAGINAL HARPER PACK-LF, Pack Number DYNJ0161768D; 3) ROBOT LAP TOTAL HYST, Pack Number DYNJ907811A; 4) VAG HYSTE PACK-LF, Pack Number DYNJ0773613J; 5) VAG HYSTERECTOMY
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1467-2025·2025-04-02
Checkpoint Guardian Intraoperative Lead: Potential Electrical Exposure Risk
Adhesive may not fully encapsulate metallic components on Checkpoint Guardian Intraoperative Leads, creating potential for electrical current leakage. This could cause inconsistent muscle responses and incorrect surgical actions.
Product
Brand Name: Checkpoint Guardian Intraoperative Lead Product Name: Checkpoint Guardian Intraoperative Lead, Medium Model/Catalog Number: REF# 9525 (Medium) Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for providing
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1446-2025·2025-04-02
Medline Delivery and Labor Kits Recalled for Defective Plastic Syringes
Medline is recalling 1,958 delivery and labor procedure kits containing plastic syringes with leaks, breakage, and quality defects that may pose a risk to patient health.
Product
Medline procedure kits labeled as: 1) DELIVERY PACK, Pack Number DYNJ0923016; 2) DELIVERY PACK-LF, Pack Number DYNJ0968863M; 3) L & D PACK-LF, Pack Number DYNJ0373290N; 4) L&D PACK, Pack Number DYNJ51998A; 5) LABOR & DELIVERY PACK-LF, Pack Number DYNJ0348455P; 6) LAB
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1440-2025·2025-04-02
Medline Procedure Kits Recalled for Defective Syringes Posing Patient Risk
Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.
Product
Medline procedure kits labeled as: 1) CT BIOPSY PACK, Pack Number DYNJ62734A; 2) E R C P PACK, Pack Number DYNJ44115A; 3) LARGE BIOPSY PACK NTX, Pack Number DYNJ68393A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1443-2025·2025-04-02
Medline CV Neonatal Procedure Kits Recalled Due to Syringe Quality Issues
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) CV NEONATAL PACK, Pack Number DYNJ67356
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1422-2025·2025-04-02
Software Malfunction Disables Back Control on Baxter TruSystem 7500
Baxter TruSystem 7500 medical devices are affected by a software issue that prevents the upper back section from operating when emergency mode is enabled. Approximately 1,709 units have been recalled nationwide.
Product
Baxter TruSystem 7500, Product Code 4091000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1415-2025·2025-04-02
Baxter Floor Mounting Column TS 7500 U Software Issue Affects Emergency Function
Baxter is recalling 33 units of the Floor Mounting Column TS 7500 U due to a software defect that prevents upper back adjustment when emergency mode is enabled.
Product
Baxter Floor mounting column TS 7500 U, Product Code 1730732
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1418-2025·2025-04-02
Baxter TruSystem 7500 Hybrid: Software Issue Disables Back Adjustment
Baxter is recalling the TruSystem 7500 Hybrid due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1410-2025·2025-04-02
Baxter TruSystem 7500 Stationary Column Recalled for Software Emergency Mode Defect
Baxter Healthcare is recalling 462 units of the TruSystem 7500 Stationary column due to a software issue that prevents the upper back section from being adjustable when emergency mode is enabled.
Product
Baxter Stationary column TruSystem 7500, Product Code 1717020
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0296-2025·2025-04-02
Compounded Fentanyl-Bupivacaine Epidural Injections Recalled for Sterility Failure
QuVa Pharma recalls compounded fentanyl-bupivacaine epidural injections due to lack of assurance of sterility. The recall affects 2,310 cassettes distributed nationwide.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 10
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1451-2025·2025-04-02
Medline Procedure Kits with Defective Plastic Syringes Recalled for Safety
Medline is recalling medical procedure kits containing plastic syringes with quality defects including leaks and breakage that may pose a risk to patient health. The recall affects 5,132 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) AOP/BASIC EYE PACK-LF, Pack Number DYNJ0589795V; 2) CATARACT CM-LF, Pack Number DYNJ39921B; 3) CATARACT EYE, Pack Number DYNJ45662C; 4) CATARACT PACK, Pack Number DYNJ56056B; 5) CATARACT PACK, Pack Number DYNJ56553B; 6) CATARACT
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0297-2025·2025-04-02
Compounded Fentanyl-Ropivacaine Epidural Injection Recalled Due to Sterility Assurance Concerns
QuVa Pharma is recalling 1,765 cassettes of compounded epidural injection due to lack of sterility assurance. The affected lots were distributed nationwide to institutional and office locations.
Product
fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Compounded, For Institutional or Office Use Only, QuVa Pharma, 1075 West Park One Drive, Suite 100, Su
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1427-2025·2025-04-02
CardioMEMS Heart Failure Monitoring System Recalled for Data Migration Issues
St. Jude Medical is recalling the CardioMEMS Heart Failure System due to data migration issues resulting in duplicated or missing patient information.
Product
CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS Backend Web Application Model CM4000 -Merlin.net Patient Care Network (PCN) Heart Failure Web Application Model MN6000 The CardioMEMS" HF System provides pulmonary art
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1420-2025·2025-04-02
Baxter TruSystem 7500 Hybrid Plus software issue affects emergency mode operation
Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid Plus (SC), Product Code 1854088
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1460-2025·2025-04-02
Medline ReNewal Electrophysiology Catheters Recalled for Elevated Bacterial Endotoxin Levels
Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.
Product
Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters, Medline Item Numbers: 401582R, 401904R, 401904R, 401905R, 401933R, and 401991R
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1445-2025·2025-04-02
Medline Laceration Tray Procedure Kits Recalled for Syringe Defects
Medline procedure kits containing plastic syringes affected by an FDA safety alert are being recalled. The syringes may leak or break, posing a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) LACERATION TRAY, Pack Number DYNJ17328B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1448-2025·2025-04-02
Medline C-section procedure kits recalled for syringe quality defects
Medline is recalling C-section procedure kits because plastic syringes in the kits may leak or break. The defect was identified in connection with an FDA safety alert and poses a potential risk to patient health.
Product
Medline procedure kits labeled as: 1) C SECTION, Pack Number DYNJ57622; 2) C SECTION PACK, Pack Number DYNJ48483B; 3) C SECTION PACK, Pack Number DYNJ61573; 4) C SECTION PACK, Pack Number DYNJ66801; 5) C SECTION PACK-LF, Pack Number DYNJ0367951P; 6) C SECTION PACK-LF
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1461-2025·2025-04-02
Medline Procedure Kits Recalled for Syringe Leaks and Breakage
Medline Industries is recalling 2,161 medical procedure kits containing plastic syringes with leaks and breakage issues. The affected syringes pose a potential risk to patient health and are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) BILLINGS CLINIC SC HEAD & NECK, Pack Number DYNJ33656C; 2) BLEPH/RHINO PACK, Pack Number DYNJ64669A; 3) DB ENT CSTM PACK-LF, Pack Number DYNJ33585C; 4) DENTAL PACK, Pack Number DYNJ54064; 5) EAR PACK, Pack Number DYNJ68678C; 6) EN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1441-2025·2025-04-02
Medline Surgical Procedure Kits Recalled for Syringe Leakage and Breakage
Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ABLATION PACK, Pack Number DYNJ40629B; 2) ACH LAPAROSCOPIC GB PACK, Pack Number DYNJ67756A; 3) CHRISTUS WH LAP CHOLE PACK, Pack Number DYNJ60934B 4) CRMC LAP CHOLE DIAG LAP-LF, Pack Number DYNJ61095D; 5) CYSTO PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1436-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringes
Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO PACK, Pack Number DYNJ50624A; 2) ANGIO PACK, Pack Number DYNJ30501F; 3) ANGIO PACK-LF, Pack Number DYNJ0954970G; 4) ANGIOGRAPHY 6 FRENCH PACK, Pack Number DYNJ33597J; 5) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ38120B; 6) AN
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1438-2025·2025-04-02
Medline Surgical Procedure Kits Recalled for Defective Plastic Syringes
Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.
Product
Medline procedure kits labeled as: 1) AV FISTULA PACK, Pack Number DYNJ80088; 2) AV FISTULA PACK-LF, Pack Number DYNJ0131782J; 3) CABG, Pack Number DYNJ906462B; 4) CABG ACCESSORY PACK-LF, Pack Number DYNJ0261346U; 5) CARDIAC CATH PACEMAKER-LF, Pack Number DYNJ42997C;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1419-2025·2025-04-02
Baxter TruSystem 7500 Software Issue Impairs Upper Back Adjustment in Emergency Mode
Baxter Healthcare is recalling 93 TruSystem 7500 Hybrid Plus units for a software issue that renders the upper back section inoperable when emergency mode is enabled.
Product
Baxter TruSystem 7500 Hybrid Plus (FC), Product Code 1854087
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1444-2025·2025-04-02
Medline surgical procedure kits recalled for syringe leaks and breakage
Medline procedure kits containing plastic syringes are recalled due to identified leaks, breakage, and quality issues that may pose a risk to patient health. The affected kits were distributed nationwide in the US and Canada.
Product
Medline procedure kits labeled as: 1) A & A KNEE PACK-LF, Pack Number DYNJHS0136D; 2) ABD CLOSURE PACK, Pack Number DYNJ56987B; 3) ADULT PERC PACK-LF, Pack Number PHS170994005A; 4) BASIC PACK, Pack Number DYNJ54836B; 5) BASIC PACK, Pack Number DYNJ58678A; 6) BASIC PACK, Pa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1437-2025·2025-04-02
Medline Procedure Kits Recalled Due to Defective Plastic Syringe Quality Issues
Medline is recalling 9,246 units of medical procedure kits containing defective plastic syringes with leaks and breakage that may pose a risk to patient health. The kits were distributed nationwide in the US and in Canada.
Product
Medline procedure kits labeled as: 1) ANGIO DRAPE PACK (DRLUL)-LF, Pack Number DYNJ47718D; 2) ANGIO PACK, Pack Number DYNJ69678; 3) ANGIOGRAPHY CV RAD PACK, Pack Number DYNJ64936A; 4) ANGIOGRAPHY DRAPE PACK, Pack Number DYNJ49621C; 5) ANGIOGRAPHY PACK, Pack Number DYNJ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0303-2025·2025-04-02
Sodium Bicarbonate Injection Recalled Due to Sterility Assurance Issue
Exela Pharma Sciences is recalling Sodium Bicarbonate 8.4% Injection due to lack of sterility assurance. The recall affects approximately 103,950 vials nationwide.
Product
SODIUM BICARBONATE — SODIUM BICARBONATE (SODIUM BICARBONATE)
Category
Drug
Distribution
Distributed nationwide