Browse Device Recalls

394 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 394 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 394 FDA device recalls.

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DateProductReasonClassFirm
Feb 18, 2026 Brand Name: Welch Allyn, Inc. Product Name: Welch Allyn Spot Vision Screener... Display screen may unintentionally flicker due to a software issue. Exposure to flickering lights... Class II Baxter Healthcare Corporation
Jan 13, 2026 Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3... Pumps were released without full testing being performed, including occlusion alarm testing. Class II Baxter Healthcare Corporation
Nov 28, 2025 SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2 Certain pumps have potentially been released from service with defective grease applied to the ca... Class II Baxter Healthcare Corporation
Oct 28, 2025 Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product... Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a ... Class II Baxter Healthcare Corporation
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
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 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 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 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
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
May 30, 2025 Hillrom Q-Link 13 component, Product Code 3156509, used with the following Mo... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 30, 2025 Hillrom LikoScale component, Product Code 3156232, used with the following a... The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook u... Class I Baxter Healthcare Corporation
May 12, 2025 Baxter Novum IQ Syringe Pump, product code 40800BAXUS, Baxter has identified a design issue which may cause the pump to detect the presence of a syringe... Class II Baxter Healthcare Corporation
May 9, 2025 2.5 V replacement rechargeable batteries for Hillrom WELCH ALLYN PocketScope ... The replacement rechargeable batteries inserted into the Welch Allyn PocketScope handles have the... Class II Baxter Healthcare Corporation
May 6, 2025 Affinity 4 Birthing Bed, Product Codes P3700E100429, P3700E100432, P3700E1004... There is a potential for improper crimps on the signal wires of the actuators which could result ... Class II Baxter Healthcare Corporation
Apr 24, 2025 Baxter Novum IQ LVP INFUSION SYSTEM, REF 40700BAXUS There is a potential for the Novum IQ LVP due to the potential for underinfusion following use of... Class I Baxter Healthcare Corporation
Apr 7, 2025 Welch Allyn Life2000 Ventilation system, Product Codes: 1) BT-20-0002; 2... A cybersecurity vulnerability was discovered through internal testing. Class I Baxter Healthcare Corporation
Apr 7, 2025 Welch Allyn Life2000 Compressor, Product Codes: 1) BT-80-0004; 2) BT-80-... A cybersecurity vulnerability was discovered through internal testing. Class I Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn CP150 Electrocardiograph: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn CONNEX Accessory Power Management Stand: There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 24, 2025 Welch Allyn Connex Vital Signs Monitor (CVSM): There were customer reports of devices which experienced battery-related fires. The investigation... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Connex Integrated Wall System, Product Code/Part Numbers: 1) 8... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Green Series 777 Wall System, Product Code/Part Numbers: 1) 77... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Spot Vital Signs 4400 Device, Product Code/Part Numbers: 1) 44... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn DuraShock Aneroid Gauge Sets with a Reusable Blood Pressure Cuff ... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 21, 2025 Welch Allyn Connex Vital Signs Monitor, Product Code/Part Numbers: 1) ) Pr... Undeclared natural rubber band within the packaging of certain configurations of reusable blood p... Class II Baxter Healthcare Corporation
Mar 3, 2025 Baxter NovumIQ Syringe INFUSION SYSTEM , REF 40800BAXUS Baxter Healthcare Corporation is issuing an Urgent Medical Device Recall for the Novum IQ syringe... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Mobile column TruSystem 7500, Product Code 1717023 There is a software issue which causes the upper back section to not be operable/adjustable when ... Class II Baxter Healthcare Corporation
Feb 25, 2025 Baxter Floor mounting column TS 7500 U, Product Code 1730732 There is a software issue which causes the upper back section to not be operable/adjustable when ... 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.