Browse Device Recalls
3,087 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,087 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 3,087 FDA device recalls in IL.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| Sep 19, 2024 | Baxter Operating Table TruSystem 7000 (dV) V, Product code REF 1841083 | The firm received customer reports stating that the batteries and their connectors experienced el... | Class II | Baxter Healthcare Corporation |
| Sep 18, 2024 | a. Hillrom Centrella Smart+ Medical-Surgical Hospital Bed, Product codes: P... | The beds have a potential for an interface issue with the Rauland Responder 5 Nurse Call System w... | Class II | Baxter Healthcare Corporation |
| Sep 12, 2024 | Welch Allyn Life2000 Ventilation System, REF MS-01-0118, within exterior cart... | The Life2000 ventilator may fail to initiate the Low Gas Pressure alarm if the pressure gas sourc... | Class I | Baxter Healthcare Corporation |
| Sep 12, 2024 | Abbott Alinity m STI AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... | Class II | Abbott Molecular, Inc. |
| Sep 12, 2024 | Abbott Alinity m HPV AMP Kit, used with the Alinity m System, product codes: ... | Abbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control ... | Class II | Abbott Molecular, Inc. |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) CONE BIOP... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion brand, medical procedure convenience kits, labeled as: a) FLOOR ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline CV ANESTHESIA - ROOM SET UP, REF DYNJ905503F; medical procedure conve... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) OB PACK-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) KIT LINE ... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline PEDIATRIC DRAPE PK, REF DYNJ81297; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) NEURO PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-L... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) SET UP PAC... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand, medical procedure convenience kits, labeled as: a) RADIOLOG... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Centurion PEDIATRIC/ADULT TRACHEOSTOMY T, REF TC7895; medical procedure conve... | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESI... | XXX | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Sep 4, 2024 | Medline TUBAL LIGATION PACK, REF DYNJ66230B; medical procedure convenience kit | It has been determined that certain Convenience kits that were packaged in breather pouch lot 323... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
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.