Browse Device Recalls
35,290 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 35,290 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 35,290 FDA device recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit) | Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of... | Class II | BioFire Diagnostics, LLC |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 10 cm, Inline Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 22, 2025 | Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip | Firm is initiating a removal due to continued reports of adverse events. | Class II | Olympus Corporation of the Americas |
| Oct 21, 2025 | CareLink Clinic, REF: MMT-7350 | Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Grap... | Class II | Medtronic MiniMed, Inc. |
| Oct 20, 2025 | Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03 | Medtronic personnel observed trace amounts of dry blood on the external carton label and Instruct... | Class II | Medtronic Perfusion Systems |
| Oct 20, 2025 | Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. La... | Potential for anesthesia leakage. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 20, 2025 | Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labe... | Potential for anesthesia leakage. | Class II | Mindray DS USA, Inc. dba Mindray North America |
| Oct 18, 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-B | Potential that product was leak tested with equipment outside of its expected operating range, re... | Class II | Auris Health, Inc |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | IntelePACS - InteleConnect / TechPortal | Software application that receives digital images and data to be communicated, processed, manipul... | Class II | INTELERAD MEDICAL SYSTEMS INCORPORATED |
| Oct 17, 2025 | Emdogain; Article Numbers: (1) 440.230V10, (2) 475.132V10; | The possibility for this product that is intended for demonstration purposes only to be placed in... | Class II | Straumann USA LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions ... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit P... | Device kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) in... | Class II | Olympus Corporation of the Americas |
| Oct 17, 2025 | Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed pos... | Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Oct 17, 2025 | Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassa... | Potential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positiv... | Class II | TECHNO-PATH MANUFACTURING LTD. |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 17, 2025 | MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| Oct 16, 2025 | VANTAGE GALAN 3T. CMSC Model: MRT-3020/U7. Model Number: MEXL-3020/B7. | Affected system contains components that do not meet the required distance between electrodes for... | Class II | Canon Medical System, USA, INC. |
| Oct 16, 2025 | Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed... | Due to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly t... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
| Oct 14, 2025 | Brand Name: EVIS EXERA III Duodenovideoscope Product Name: Olympus TJF-Q190V... | Continued reports of positive cultures and infections have identified updates to the reprocessing... | Class II | Olympus Corporation of the Americas |
| Oct 14, 2025 | BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarb... | Bicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactat... | Class II | Beckman Coulter Ireland, Inc. |
| Oct 14, 2025 | BD Luer Tip Caps; Catalog Number(s) or Model Number(s): 308341; | BD has confirmed through internal testing that certain device trays failed routine biocompatibili... | Class II | Becton Dickinson & Company |
| Oct 13, 2025 | DermaSensor. Model/Catalog Number: 10101. Software Version: 3.0.2. Softwar... | Potential for device to not meet specifications resulting in incorrect results or delay of referr... | Class II | DERMASENSOR INC |
| Oct 13, 2025 | MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE a... | Due to battery component overheating while charging resulting in melting of internal components a... | Class II | MRIMed Inc. |
| Oct 13, 2025 | Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S | Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of ... | Class II | Paragon 28, Inc. |
| Oct 10, 2025 | CentriMag Blood Pump, REF: 102953, 201-20003, 201-90010, 201-90016; CentriMa... | Acute circulatory support system pump may not fit into the motor and reports received of the pump... | Class II | Thoratec LLC |
| Oct 9, 2025 | Quantum Intersegmental Table, Model/Catalog Number: AMQ400H; heated massage t... | The heat function may become damaged over time due to patients pressing on the areas with heat fu... | Class II | Pivotal Health Solutions, Inc. |
| Oct 9, 2025 | Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Numbe... | Due to issues with the system's stereotactic radiosurgery (SRS) treatment cannot be guaranteed fo... | Class II | C-RAD POSITIONING AB |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular System (LVA... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | bk3500 Ultrasound System w/battery; Model No. 2300-41; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/... | Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/appro... | Class II | Myofunctional Research Company USA |
| Oct 9, 2025 | bk3000 Ultrasound System w/battery; Model No. 2300-66; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Ultrasound System 1300, bkSpecto w/battery; Model No. 1300-21 or 1300-S1; Sys... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | bk5000 Ultrasound System w/battery; Model No. 2300-61; System, Imaging, Pulse... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate 3 Controller (Standalone) Mod... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate II¿ LVAS Implant Kit Model/Ca... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | Quantum Intersegmental Table, Model/Catalog Number: Q400; heated massage table | The heat function may become damaged over time due to patients pressing on the areas with heat fu... | Class II | Pivotal Health Solutions, Inc. |
| Oct 9, 2025 | UUltrasound System 2300, bkActiv w/battery; Model No. 2300-11; System, Imagin... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 9, 2025 | Brand Name: HeartMate Product Name: HeartMate II¿ Controller (standalone) M... | Due to potential corrosion issues associated with the Backup Battery cable connector that may cau... | Class II | Thoratec LLC |
| Oct 9, 2025 | 1202 Flex Focus Ultrasound System, cart models UA1214 and UA1814, used with: ... | GE HealthCare has become aware that the Instructions for Use within the user guide and service ma... | Class II | B-K Medical A/S |
| Oct 8, 2025 | Brand Name: ACUSON, CATHETER ACUNAV DIAGNOSTIC ULTRASOUND 8FR NOT FOR USE WIT... | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... | Class II | Sterilmed, 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.