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 1, 2025 | Medline Renewal LigaSure Blunt Tip Sealer/Divider, Compatible with FT10 Gener... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK, REF CDS780202R; ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROTOMY HARPER PACK-LF, REF... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: PORT INSERTION PACK, REF DYNJ81597 | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF, REF DYNJ016... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR SINGLE BASIN PACK, REF DYNJ3... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) NEURO CRANIOTOMY CDS #36-RF, REF C... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GENERAL AAA #11-RF, REF CDS840261A... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR LAPAROTOMY CDS, REF CDS86001... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as LOCAL BASIC, REF DYNJ34418M | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CATH LAB PACEMAKER PACK, REF DYNJ59818A | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MAJOR VAGINAL HARPER PACK-LF, REF ... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY CDS #34-RF, REF CD... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: GP-LEEP PACK-LF, REF PHS396969004F | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) CENTRAL LINE PACK, REF DYNJ00281P; 2... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: CIRCUMCISION PACK, REF DYNJ16826O | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 30, 2025 | MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983... | Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... | Class II | Medline Industries, LP |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266122 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit" SAL... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Si... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 17, 2025 | Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp... | Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. ... | Class II | Baxter Healthcare Corporation |
| Sep 11, 2025 | Excelsior Medical, 0.9% Sodium Chloride Injection, USP - 10 mL Fill, Item Num... | Medline has identified a limited quantity of saline IV flush syringes that may not meet the requi... | Class II | Medline Industries, LP |
| Sep 10, 2025 | Medline Adult Anesthesia Set, REF DYNJ39985G | Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due t... | Class II | Medline Industries, LP |
| Aug 29, 2025 | CLEARLINK SYSTEM Solution Set, Non-Vented, two CLEARLINK Luer Activated Valve... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, thr... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Act... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK System Non_DEHP Extenstion Set, Straight-Type Extension Set, Standa... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, ... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CONTINU-FLO Solution Set, Non-Vented, two CLEARLINK Luer Activated Valves, Ba... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK System Paclitaxel Set, Non-Vented with Polyethylene Lined Tubing an... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM NON-DEHP CONTINU-FLO SOLN SET, 96" (2,4 m), Product Code: 2... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM EXTENSION SET, Straight-Type Extension Set, Standard Bore, C... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, 0.2 Micron Filter, two... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK SYSTEM CONTINU-FLO Solution Set, Non-Vented, three CLEARLINK Luer A... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 29, 2025 | CLEARLINK System Solution Set, DUO-VENT, CLEARLINK Luer Activated Valve, 10 d... | IV sets may leak. | Class II | Baxter Healthcare Corporation |
| Aug 28, 2025 | Sharesource Connectivity Platform for Use with Homechoice Claria Product C... | Vantive has identified a software defect within the Sharesource Claria software, which may cause ... | Class II | Vantive US Healthcare LLC |
| Aug 21, 2025 | Medline Kits: 1) VALVE PACK-LF, Model Number: DYNJ0415366P; 2) VALVE PACK-... | The kits contain certain lots of cannula products where the catheter may not retain its shape. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) MAJOR PACK L-F, Model Number: DYNJ03827... | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
| Aug 8, 2025 | Sterile Medline Convenience Kits: 1) EXTREMITY PACK, Model Number: DYNJ45701B | Convenience kits labeled as sterile have not gone through the sterilization process. | Class I | Medline Industries, LP |
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.