Browse Device Recalls
39,885 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,885 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 39,885 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge HD Model/Catalog Number: Q6... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 1450 Model/Catalog Number: ... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: 4Front Model/Catalog Number: 4Front... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum 4Front 2 Model/Catalog Numb... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Quantum Outback Model/Catalog Numbe... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Brand Name: Quantum Rehab Product Name: Q6 Edge 3 Stretto Model/Catalog Num... | If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appe... | Class II | Pride Mobility Products Corp. |
| Jun 25, 2026 | Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that pro... | Due to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage t... | Class I | ResMed Ltd. |
| Jun 24, 2026 | BIOFIRE Respiratory Panel 2.1 (RP2.1) REF 423742 UDI code: 00815381020529 ... | Due to increase in false negative results | Class II | BioFire Diagnostics, LLC |
| Jun 24, 2026 | Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623 | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 90 Absorbable Wound Closure Device VLOC 90 0 VL 22 GS-21 VLOCM033... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Surgipro II S8698GX SURGIPRO II BL 5/0 18 P-13 S8698GX | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING ... | Product may contain a perforation or tear in the sterile barrier packaging. This issue may result... | Class II | Covidien, LP |
| Jun 24, 2026 | Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40... | Events observed where anesthetic agent was not delivered when the vaporizer was activated. Failur... | Class II | Maquet Critical Care AB |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula BLUNT 22FR, intended for use with c... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA 3D Arterial Cannula DIL TIP 22FR, intended for use with cardiopulmonary ... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA 3D Arterial Cannula 22FR, intended for use with cardiopulmonary bypass a... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | EOPA Elongated One-Piece Arterial Cannula DIL TIP 22FR, intended for use with... | Pinhole leaks may occur in the wire-wound body during cardiopulmonary bypass. Potential risks ass... | Class II | Medtronic Perfusion Systems |
| Jun 24, 2026 | Hotline Fluid Warming Set, single use device, is designed to warm blood and i... | ICU Medical became aware of an increased likelihood of leakage in specific Lots of L-70 HOTLINE F... | Class II | ICU Medical Inc. |
| Jun 23, 2026 | Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-2... | Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility a... | Class II | Arrowhead DE LLC |
| Jun 23, 2026 | Charger for the Therabody Theragun, G4 PRO massage device, and products which... | Charging cradle for the device may overheat while charging the device's removable battery pack, p... | Class II | Therabody, Inc |
| Jun 19, 2026 | munevo DRIVE and munevo DRIVE r-net Powered Wheelchair Hands-Free Control ... | A software issue may cause the wheelchair's driving mechanism to fall out of calibration. When th... | Class II | MUNEVO GMBH |
| Jun 19, 2026 | Boston Scientific TheraSphere 360 Y-90 Management Platform, Model Number M001... | Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns t... | Class II | Boston Scientific Corporation |
| Jun 19, 2026 | Power F2 Powered Fastening System, Product No. 0567091 Powered fastening sy... | Product may experience accelerated roller wear and potential deformation due to interference betw... | Class II | Ferno-Washington Inc |
| Jun 17, 2026 | Philips Allura under the following System Descriptions and corresponding mode... | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 17, 2026 | Philips Azurion under the following System Descriptions and corresponding mod... | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 17, 2026 | Philips Allura, Cardio Vascular-Allura Centron. Model Number: 722400. Inte... | Potential Loss of imaging functionality, loss of motorized movement, or loss of data due to unaut... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jun 17, 2026 | INFINION CX LEAD KIT, 50CM, Model: SC-2317-50, Material: M365SC2317500; INF... | Spinal cord stimulation system lead body may be exposed to stress at the anchor site. This may re... | Class I | Boston Scientific Neuromodulation Corporation |
| Jun 17, 2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... | Class II | Freudenberg Medical, LLC |
| Jun 17, 2026 | Blom-Singer Classic Indwelling Voice Prosthesis, 16Fr/10 mm REF: 1610-LEF | Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal a... | Class II | Freudenberg Medical, LLC |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pac... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr F... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KI... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tra... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cat... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerv... | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical So... | Class II | Windstone Medical Packaging, Inc. |
| Jun 17, 2026 | P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped G... | Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of... | Class II | Paragon 28, Inc. |
| Jun 17, 2026 | Ventriculostomy Kit, REF: 46154 | Ventriculostomy devices, used during ventriculostomy procedures to gain access to the ventricular... | Class II | Medtronic Neurosurgery |
| Jun 16, 2026 | 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235... | Products may not have received adequate sterilization processing. | Class II | BD SWITZERLAND SARL |
| Jun 16, 2026 | Brand Name: WASPLab Product Name: WASPLab Model/Catalog Number: W087 Softw... | Due to a software issue within the WebApp that potentially prevents the user to overwrite the res... | Class II | Copan WASP |
| Jun 16, 2026 | Olympus High Flow Insufflation Unit - UHI-4. Model Number: UHI-4 | Potential for unexpected instances where the front panel display turns off unexpectedly, and air ... | Class II | Olympus Corporation of the Americas |
| Jun 16, 2026 | MiniMed Go App, Model: MMT-8600 (iOS), MMT-8601 (Android) | For MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and misse... | Class II | Medtronic MiniMed, Inc. |
| Jun 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| Jun 16, 2026 | Cyberknife Treatment Deliver System equipped with the Xchange Robotic Collima... | In certain cases, a collimator may not fully dock, which triggers a system interlock and prevents... | Class II | Accuray Incorporated |
| Jun 15, 2026 | One-Piece Guedel Airway, size 00, ISO 5.0, Blue. Oropharyngeal Airway Device. | Devices could potentially be occluded or partially occluded. | Class II | Intersurgical Inc |
| Jun 15, 2026 | One-Piece Guedel Airway, size 000, ISO 3.5, Light Green. Oropharyngeal Airway... | Devices could potentially be occluded or partially occluded. | Class II | Intersurgical 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.