Browse Device Recalls
2,805 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,805 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 2,805 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 15, 2025 | Allura Xper FD10; Model Number: 722026; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10 | Nasal feeding tube packaged without the nasal transfer tube component. | Class II | Wilson-Cook Medical Inc. |
| Dec 15, 2025 | Allura Xper FD20 Biplane; Model Number: 722013; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD20 OR Table; Model Number: 722023; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument. | Presence of particulates in affected devices that can be deposited into breast tissue during use. | Class II | Hologic, Inc |
| 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 | Plum Duo Infusion System, List Number 40002-04-01 | ICU Medical received one lot of defective primary speakers from our supplier that may fail to pro... | Class II | ICU Medical, Inc. |
| 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 | Allura Xper FD20 Biplane; Model Number: 722008; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sampl... | Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, a... | Class II | Sysmex America, Inc. |
| Dec 15, 2025 | Allura Xper FD10; Model Number: 722010; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 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 | ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 (US), 400021... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | Allura Xper FD20/10; Model Number: 722029; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit ... | Potential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted... | Class II | Diagnostica Stago, Inc. |
| Dec 15, 2025 | Allura Xper FD20; Model Number: 722012; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD10/10; Model Number: 722005; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: M... | The console label for affected devices is missing the "DANGER" symbol. | Class II | LEASEIR TECHNOLOGIES SLU |
| Dec 15, 2025 | Allura Xper FD20/20; Model Number: 722038; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD10/10; Model Number: 722011; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 40001... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 ... | Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the... | Class II | ICU Medical, Inc. |
| Dec 15, 2025 | Allura Xper FD10; Model Number: 722003; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Product Name: Allura Xper FD10C; Model number: 722001; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD20; Model Number: 722028; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | Allura Xper FD10/10; Model Number: 722027; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| 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 | Allura Xper FD10F; Model Number: 722002; | Philips has identified that in a limited number of impacted systems the drip tray beneath the coo... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 15, 2025 | da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 ... | Access Port System tray may develop cracks potentially resulting in a sterility breach. | Class II | Intuitive Surgical, Inc. |
| Dec 15, 2025 | Estrone RIA, REF: DSL8700 | The affected Estrone RIA kit lots may rarely give falsely high patient results which might cause ... | Class II | Immunotech A.S. |
| Dec 14, 2025 | Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, ... | Due to a manufacturing issue and electrical grounding of systems. | Class II | Elekta, Inc. |
| Dec 12, 2025 | Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman ... | Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Mi... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: CIRCUMCISION PACK, Ki... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, ... | due to a defect associated with the conductivity values of the solution used to calibrate meters ... | Class II | NIPRO Technical Services, Inc. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) MEM MAXILLOFACIA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor. | It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead... | Class II | Philips North America Llc |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planni... | Due to an error when defining a new stereotactic reference that users fail to first change an alr... | Class II | Elekta, Inc. |
| Dec 12, 2025 | Philips Azurion Systems with software versions R2.1.10 and R2.2.10. Includes ... | Six (6) identified software issues which may result in the following: system keeps restarting, AM... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) RR-GYN LAPAROSCO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DEPAUL BASIC NEU... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | ThinPrep¿ CytoLyt¿ Solution. Buffered Cell Wash Solution. | Fungal contamination of affected lot with Parengyodontium album. | Class II | Hologic, Inc |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) CATH LAB PACEMAK... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) C-SECTION PACK, ... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) DRAWER 1 AIRWAY,... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: HEAD SHAVE-LATEX SAFE... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) INPATIENT CTRL L... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) SMJ LAP CHOLE PA... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
| Dec 12, 2025 | Medline medical procedure convenience kits labeled as: 1) BREAST-HERNIA-PO... | Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was reca... | Class II | Medline Industries, LP |
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.