Browse Device Recalls
2,910 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,910 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Medical Device Recalls
Browse 2,910 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 15, 2024 | Medline Shoulder Repair Pack-LF, REF DYNJ82607, 2 kits/case, sterile. | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile;... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 15, 2024 | (1) Medline Pacer Implant Pack, REF DYNJ59194A, 4 kits/case, sterile; and (2... | Some of the suture packages within the convenience kits contain the incorrect needle type/size an... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 11, 2024 | Hillrom Welch Allyn XScribe Cardiac Stress Testing System; Programmable Diagn... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn HScribe Holter System; ambulatory monitoring | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn RScribe 12-Lead Electrocardiograph System; Electrocardiog... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Diagnostic Cardiology Suite (formerly Connex Cardio); Dia... | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Q-Stress Cardiac Stress Testing System; cardiac stress test | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 11, 2024 | Hillrom Welch Allyn Vision Express Holter Analysis System; Electrocardiograph | There is the potential for exam files being assigned duplicate Unique Identifiers (UIDs),. If th... | Class II | Baxter Healthcare Corporation |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY, REF CDS76005... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF, REF CDS780112... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK, REF DYNJ44... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ01... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF, REF CDS983478L; 2)... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS, REF CDS983184... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK, REF DYN... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) VAGINAL, REF CDS984955M; 2) DAY ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK, REF DYNJ80686A... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID, REF DYNJ524... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | Refer to RES or lead review memo for complete list of affected reference/cata... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CVL PACK, REF DYNJ00281O; 2) VAS... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF, REF CDS760... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS, REF CDS985... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) TRACH TOTE, REF DYNJ85691; 2) TR... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK, REF DYNJ16826O;... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF, REF CDS760059I... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BURN, REF CDS983465M; 2) BURN, R... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202P; ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF, REF CDS840232L; ... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK, REF DYNJ52141B | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075V... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: L&D MINOR PACK, REF DYNJ82672 | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D; 2)... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF, REF DY... | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 9, 2024 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuat... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 4, 2024 | ARTHROSCOPY Convenience kit used for surgical procedures, SKU SYNJ910004C | Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 4, 2024 | CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A | Products within a Medline pack may be impacted by a packaging error in which an incomplete seal h... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Oct 3, 2024 | GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1... | GE HealthCare has become aware of an issue in Centricity Universal Viewer Zero Footprint Client (... | Class II | GE Healthcare |
| Oct 2, 2024 | Baxter Spectrum IQ Infusion System with Dose IQ Safety Software, Product Code... | The door on the Spectrum IQ Infusion pump may not be able to fully close. | Class II | Baxter Healthcare Corporation |
| Sep 25, 2024 | Monoject U-100 1 mL Insulin Syringe Luer-Lock with Tip Cap Soft Pack, REF 118... | Certain lots of listed lots of Cardinal Health Monoject U-100 1 mL Insulin Syringe Luer-Lock with... | Class I | Cardinal Health 200, LLC |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW) V, Product code REF 2065386 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW), Product code REF 1841048 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating table TruSystem 7000 U (MB), Product codes: a) REF 160478... | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (dV), Product code REF 1841049 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000, Product code REF 1841046 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 V, Product code REF 1841050 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (MBW) V, Product code REF 1841082 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 U14 (MBW), Product code REF 2065385 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
Frequently Asked Questions
When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.
All types — from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.
Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.