Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips L12-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips XL14-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S8-3t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X7-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips 3D9-3v Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips S7-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips S5-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips V6-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Ca... | Due to an error in assembly of the thermistor within some units, the affected probes will experie... | Class II | Terumo Cardiovascular Systems Corporation |
| May 28, 2025 | Philips X8-2t Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips X6-1 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips L12-3 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips C5-2 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Philips eL18-4 Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips C9-5EC Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 28, 2025 | Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL ... | Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actua... | Class II | Encore Medical, LP |
| May 28, 2025 | Philips eL18-4 EMT Transducer. | Ultrasound transducer devices were refurbished beyond their useful life. | Class II | Philips Ultrasound, Inc |
| May 27, 2025 | O-arm O2 Imaging System. Mobile X-Ray System. | A mechanical component that supports the O2 gantry to the support structure in affected devices m... | Class II | Medtronic Navigation, Inc.-Boxborough |
| May 27, 2025 | KWIK-STICK, Quality control kit for culture media, Catalog Numbers 01065K... | Affected products were packaged with the incorrect KWIK STIK assembly resulting in the product co... | Class II | Microbiologics Inc |
| May 23, 2025 | Omnipod 5 Automated Insulin Delivery System, iOS Application. Model Number: P... | Insulet Corporation is recalling Omnipod 5 iOS App, due to a software design issue in which a com... | Class II | Insulet Corporation |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2025 | MicroMyst Applicator, Box of 5. Consisting of a multilumen applicator and fil... | Lack of sterility assurance. | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 23, 2025 | Discovery MR750w 3.0T | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6... | This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing ... | Class II | Steris Corporation |
| May 23, 2025 | SIGNA PET/MR | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2025 | Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters... | Medline Industries, LP. is issuing a recall for specific Medline kits containing BD Insyte Autogu... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| May 23, 2025 | Jewel Precision Reusable Rigid Sterilization Container System. Model Number: ... | The 8-inch model of the Jewel Precision Reusable Rigid Sterilization Container System (i.e., mode... | Class II | Jewel Precision Sheet Metal & Machining Co, Inc. |
| May 23, 2025 | SIGNA Architect AIR | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE¿ device is a ... | Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planni... | Class II | QUANTUM SURGICAL SAS |
| May 23, 2025 | SIGNA Architect | GE HealthCare has become aware that gradient coils for certain MR systems (see affected product l... | Class II | GE Medical Systems, LLC |
| May 23, 2025 | Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-5... | Investigation has identified that the age of the nylon packaging material has caused a loss of in... | Class II | CORIN MEDICAL, LTD. |
| May 22, 2025 | Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN):... | Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality ... | Class II | Siemens Healthcare Diagnostics, Inc. |
| May 22, 2025 | IontoPatch STAT, On-the-Go Patch Therapy, Model/Catalog Number D-0062-080; Io... | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... | Class II | LTS Therapy Systems, LLC |
| May 22, 2025 | IontoPatch 80, On-the-Go Patch Therapy, Model/Catalog Number: D-0077-080; T... | The nonwoven pads in the device do not absorb the saline solution or any other liquid intended to... | Class II | LTS Therapy Systems, LLC |
| May 22, 2025 | Extended Tip Applicator 8CM, Box of 1. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog ... | The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility she... | Class II | Jewel Precision Sheet Metal & Machining Co, Inc. |
| May 22, 2025 | Femoral Nail, RIGHT T2 GTN 8x300 mm. Catalog Number: 1851-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... | Class II | Stryker GmbH |
| May 22, 2025 | Change Healthcare Cardiology Hemo Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 22, 2025 | Extended Tip Applicator, 8CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Femoral Nail, LEFT T2 GTN 8x300 mm. Catalog Number: 1850-0830S. | Investigation determined that one lot of the T2 Greater Trochanter Nail (GTN) was labeled as left... | Class II | Stryker GmbH |
| May 22, 2025 | Extended Tip Applicator, 15 CM, Box of 5. | Devices contain potentially out-of-specification levels of endotoxins and lack of sterility assur... | Class I | Integra LifeSciences Corp. (NeuroSciences) |
| May 22, 2025 | Change Healthcare Cardiology Hemodynamics Software | Due to complaints, software update may cause software to unexpectedly shutdown. | Class II | CHANGE HEALTHCARE CANADA COMPANY |
| May 21, 2025 | REF: 382633, BD Insyte Autoguard BC Winged, Shielded IV Catheter with Blood C... | Due to customer complaints, there is the possibility that catheter needle may be slow to retract ... | Class II | Becton Dickinson Infusion Therapy Systems, Inc. |
| May 21, 2025 | LUCAS 2, 3 and 3.1 LUCAS chest compression System is to be used for perfor... | Due to demonstration units of chest compression system being provided to a customer which may pot... | Class II | Jolife AB |
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.