Browse Device Recalls
3,415 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,415 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 3,415 FDA device recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Feb 6, 2026 | Owner's Booklets and Instructions for Use that are used with the following bl... | The system labeling (user manual and online labeling) did not provide adequate directions for lay... | Class I | Trividia Health, Inc. |
| Jan 27, 2026 | Impella RP. Product Code: 0046-0011. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP with SmartAssist. Product Code: 0046-0035. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 27, 2026 | Impella RP Flex with SmartAssist. Product Code: 1000323. | Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to... | Class I | Abiomed, Inc. |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insuffla... | Issue with software algorithm which may lead to overpressure events. | Class I | Olympus Corporation of the Americas |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insuf... | Issue with software algorithm which may lead to overpressure events. | Class I | Olympus Corporation of the Americas |
| Jan 16, 2026 | Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insuff... | Issue with software algorithm which may lead to overpressure events. | Class I | Olympus Corporation of the Americas |
| Dec 22, 2025 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheters: ViewFlex Xtra ICE... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Liv... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheters: ... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Cathet... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON ... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Medline ReNewal Reprocessed Webster CS Catheters: Webster CS Catheter 10 E... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 22, 2025 | Reprocessed Abbott Inquiry Steerable Diagnostic Catheters: Abbott Inquir... | These lots of reprocessed catheters may contain small particles of residual material. If affected... | Class I | Medline Industries, LP |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Ma... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Materia... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | *HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 20mm x 10mm; ... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | AXIOS Stent and Electrocautery-Enhanced Delivery System - 20mm x 10mm; Mater... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 19, 2025 | HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 6mm x 8mm; Mat... | Increased reports of stent deployment and expansion issues. The most common outcome reasonably fo... | Class I | Boston Scientific Corporation |
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | SunMed Holdings, LLC |
| Dec 15, 2025 | Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Mode... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | SunMed Holdings, LLC |
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer ... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | SunMed Holdings, LLC |
| Dec 15, 2025 | Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape... | Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine. | Class I | SunMed Holdings, LLC |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Semi Electric Basic Homecare Bed, REF MDR107002E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impu... | Class I | Draeger, Inc. |
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research LLC |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impu... | Class I | Draeger, Inc. |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system Power Management Board (PMB) Fiel... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 14, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the cont... | Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious pa... | Class I | Fresenius Kabi USA, LLC |
| Nov 14, 2025 | GE Healthcare Carestation anesthesia system, product number and REF numbers: ... | Potential unexpected shutdown of Carestation 600 and 700 Series Anesthesia Systems containing cer... | Class I | GE Medical Systems China Co., Ltd. |
| Nov 11, 2025 | Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08 | Devices are not suitable for organ transplant. | Class I | AVID Medical, Inc. |
| Nov 11, 2025 | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15. | Devices are not suitable for organ transplant. | Class I | AVID Medical, Inc. |
| Nov 11, 2025 | Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17. | Devices are not suitable for organ transplant. | Class I | AVID Medical, Inc. |
| Nov 10, 2025 | ErgoStar CM 55, Model/Catalog Number: MP01855, Airway connector for c... | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Draeger, Inc. |
| Nov 10, 2025 | ErgoStar CM 40 Model/Catalog Number: MP01840 Airway connector for condu... | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Draeger, Inc. |
| Nov 10, 2025 | ErgoStar CM 45, Model/Catalog Number: MP01845, Airway connector for co... | Multiple complaints were reported in which cracks formed in the hose of specific catheter mounts. | Class I | Draeger, Inc. |
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.