Browse Device Recalls
34,057 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 34,057 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 34,057 FDA device recalls — Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 | 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 | 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 | 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 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 | 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 | 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 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 Curved Extensions wi... | A potential issue with the seal integrity of header bag packaging. | Class II | Mozarc Medical US LLC |
| 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 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 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 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 | 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 | 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 | 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 | 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 | 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 | 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 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 8, 2025 | Brand Name: Sterilmed Reprocessed Imaging Catheter Product Name: ACUSON, CAT... | Affected catheters were reprocessed beyond validated cycles. This may compromise device sterility... | Class II | Sterilmed, Inc. |
| 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. |
| Oct 8, 2025 | REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60, ... | Automated cell-locating device barcode reader may read the barcode of the previously processed sl... | Class II | Cellavision AB |
| Oct 8, 2025 | Brand Name: Lithotriptor, Ultrasonic Product Name: ShockPulse Lithotripsy Tr... | The device may either fail to start up, or the transducer may start briefly and then stop, accomp... | Class II | Olympus Corporation of the Americas |
| Oct 7, 2025 | GM85 Digital Mobile X-ray imaging System; Model Number: GM85; | The four (4) M5 bolts that secure the Tube Head Unit to the end of the arm may loosen or fracture... | Class II | NeuroLogica Corporation |
| Oct 7, 2025 | Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Ac... | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... | Class II | Meridian Bioscience Inc |
| Oct 7, 2025 | Good Neighbor Pharmacy, TRUE METRIX Self Monitoring Blood Glucose Meter. Mode... | Manufacturing defect causing LCD display issues with missing or partial segments (ghosting) that ... | Class II | Trividia Health, Inc. |
| Oct 7, 2025 | Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Ac... | The cap on the reaction buffer tube may be missing the black rubber gasket resulting in the poten... | Class II | Meridian Bioscience Inc |
| Oct 7, 2025 | SimplyGo Mini, Standard Battery Kit; Product code: 1116816; The affected ... | Certain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which c... | Class II | Philips Respironics, Inc. |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 5 f - 6F x 55 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Brand Name: Olympus Single Use Electrosurgical Snare SD-400 Product Name: Si... | Sterility compromised from small holes that may occur during packaging of the device pouches into... | Class II | Olympus Corporation of the Americas |
| Oct 6, 2025 | Eterna SCS IPG (Implantable Pulse Generator), Model Number 32400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Oct 6, 2025 | IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 1038... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, 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.