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.

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DateProductReasonClassFirm
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
Aug 8, 2025 Baster Continu-Flo Solution Set, Non-Vented, 2 Clearlink Luer Activated Valve... Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for one lot of Continu-F... Class II Baxter Healthcare Corporation
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40700BAX, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Aug 4, 2025 Novum IQ LVP (Large Volume Pump), Product Code 40700BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Aug 4, 2025 Novum IQ Syringe Pump, Product Code 40800BAXUS, infusion pump Baxter Healthcare Corporation is issuing an Urgent Medical Device Correction for the Novum IQ Lar... Class I Baxter Healthcare Corporation
Jul 31, 2025 Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac structures; blood... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed ACUSON AcuNav Ultrasound Catheter for intracardiac and intra-lumi... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Inquiry Steerable Diagnostics Catheter for electrogram recording ... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Webster CS Catheter 10 Electrodes for electrophysiological mappin... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 31, 2025 Reprocessed Livewire Steerable Electrophysiology Catheter Item Numbers 401... Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residua... Class I Medline Industries, LP
Jul 28, 2025 PrisMax V3 control Unit-US, Hemodialysis Delivery System, Product Code 955724 Unexpected PrisMax System alarm T0830: Blood Leak Detected, when no blood leak is present, or dif... Class II VANTIVE US HEALTHCARE LLC
Jul 28, 2025 TherMax Blood Warmer Unit-US, PrisMax Accessory, Product Codes: 955630, 9555... Thermax System may be unable to detect the presence of a bag on the Thermax Blood Warmer Unit lea... Class II VANTIVE US HEALTHCARE LLC
Jul 28, 2025 PrisMax V2-US, Hemodialysis Delivery System, Product Codes: 955626, 955558, ... Low deaeration chamber level at post priming tests may lead to PrisMax System alarm T2309: Air De... Class II VANTIVE US HEALTHCARE LLC
Jul 25, 2025 Medline medical convenience kits labeled as: 1. NEWBORN RESUSCITATION KIT,... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 25, 2025 Medline medical convenience kits labeled as: 1. ADULT INTUBATION TRAY, Kit... Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits contai... Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 23, 2025 Medline Kits containing BD SureStep Foley Tray Systems: SKU/Description: ... Kits contain SureStep Foley Tray Systems recalled by BD that include incorrect product informatio... Class II MEDLINE INDUSTRIES, LP - Northfield
Jul 14, 2025 Spectrum IQ Infusion Pump, Product Code 3570009 Baxter has identified that certain pumps have potentially been released with the grease applied t... Class II Baxter Healthcare Corporation
Jul 14, 2025 Medline ReNewal Reprocessed St. Jude Medical Response and Supreme Diagnostic ... Specific lots of reprocessed electrophysiology catheters may contain small residual particulates. Class I MEDLINE INDUSTRIES, LP - Northfield
Jul 14, 2025 Baxter Novum IQ Large Volume Pump, Product Code REF 40700BAXUS Baxter is issuing an Urgent Medical Device Correction for the Novum IQ large volume pump (LVP) du... Class I Baxter Healthcare Corporation
Jul 11, 2025 Plum Duo Infusion System, List Number: 400020401 ICU Medical identified two sequences of programming events and alarm interactions that may cause ... Class I ICU Medical, Inc.
Jul 8, 2025 The Medline General Surgery Tray is customized to meet requirements of the ho... Affected kits contain recalled Stryker Color Cuff Sterile Disposable Tourniquet Cuffs. Stryker In... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2 Certain Spectrum infusion pumps may have an incorrect version of software. Class I Baxter Healthcare Corporation
Jun 20, 2025 Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX Certain Spectrum infusion pumps may have an incorrect version of software. Class I Baxter Healthcare Corporation
Jun 16, 2025 SwabFlush Prefilled Syringe with ICU Medical SwabCaps, 10mL Model no. EMZE01... SwabFlush syringes are affected by the ICU Medical recall of their SwabCap Disinfecting Cap due t... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Prepara... The firm issued a field safety notice after becoming aware of three lots of products not having q... Class II Bridge to Life Ltd
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... Class II MEDLINE INDUSTRIES, LP - Northfield
Jun 12, 2025 Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, la... Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by ... 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.