Browse Device Recalls
474 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 474 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 474 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 18, 2026 | PRO+ 36" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ MRS SURFACE FOR VERSACARE, mattress with Advanced Microclimate Technolog... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 18, 2026 | PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) us... | There is an error in the product description on the Unique Device Identification (UDI) label. The... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSL | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 11, 2026 | Baxter Novum IQ Syringe Pump, Model Number 40800BAXUS | A software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe ... | Class II | Baxter Healthcare Corporation |
| Aug 3, 2026 | Brand Name: VOLARA System Product Name: VOLARA, HC, NA A Model/Catalog Numb... | Contamination within the release test equipment flow path could have affected the accuracy of the... | Class II | Baxter Healthcare Corporation |
| Jun 30, 2026 | Baxter Duo-Vent Solution Set and Male Luer Lock Adapter, Product Code 1C8507;... | Baxter received customer reports of air bubbles in the drip chamber and tubing when a pressure cu... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Hillrom VOLARA P.CIRCUIT 5KIT (System Single Patient Use Circuit), Model/Cata... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT (Single Patient Use Circuit), Model/Catal... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT 5KIT AC, (Single Patient Use Circuit), Model/... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| May 21, 2026 | Hillrom VOLARA System P.CIRCUIT KIT AC (Single Patient Use Circuit), Model/Ca... | There have been reports of air and medication leakage from the nebulizer cup during therapy of Vo... | Class I | Baxter Healthcare Corporation |
| Apr 22, 2026 | Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalo... | Affected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of th... | Class II | Baxter Healthcare Corporation |
| Apr 21, 2026 | Adapter for Head Positioning, Model/Catalog Number: 1739994, when used in con... | The Adapter for Head Positioning accessory may become loose during patient positioning and uninte... | Class II | Baxter Healthcare Corporation |
| Feb 18, 2026 | Blue Ventilator Adapter Module, single-patient use circuit, Product Code M079... | Urgent Medical Device Correction for the Volara system single-patient use circuit due to the pote... | Class I | Baxter Healthcare Corporation |
| 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 |
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.