Browse Device Recalls
460 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 460 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 460 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.