Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | SJM Pericardial Patch, with EnCap Technology 9x14cm, Model Number REF C0914;... | The impacted lot may not meet the required tensile strength specification. | Class I | Glycar SA Pty., Ltd. |
| 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 | SJM Pericardial Patch, with EnCap Technology 5x10 cm, Model Number REF C0510... | The impacted lot may not meet the required tensile strength specification. | Class I | Glycar SA Pty., Ltd. |
| 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 | Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are batt... | Insulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or ma... | Class I | Tandem Diabetes Care, 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. |
| Oct 6, 2025 | 3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE ... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F 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 Single Use Electrosurgical Snare SD-400 Produ... | 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 | Applied Medical Technology, Inc., NutraGlide, 5 F- 6 F x 90 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 55 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 6, 2025 | Liberta RC DBS IPG (Implantable Pulse Generator), Model Number 62400 | There is a potential issue affecting Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Gener... | Class II | Abbott Medical |
| Oct 6, 2025 | OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materi... | A labeling error was identified on the affected product. The expiration date on the kit box label... | Class III | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC P... |
| Oct 6, 2025 | Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Ca... | The barcode orientation on affected devices causes incorrect scanning order of tubes within the a... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Oct 6, 2025 | Applied Medical Technology, Inc., NutraGlide, 6 F- 8 F x 90 Nasal Feeding Tub... | The nasal feeding tube may be occluded | Class II | Applied Medical Technology Inc |
| Oct 3, 2025 | TruDi¿ Navigation System - Multi Instrument Adapter; - Manufacturer's Produc... | It was determined that when the navigation system is configured with specific revision combinatio... | Class II | Integra LifeSciences Corp. (NeuroSciences) |
| Oct 3, 2025 | MEDLINE STERILE BASIC EYE PACK 16: 1) REF: DYNJ37743D; 2) REF: DYNJ37743F. | Medline has identified specific sterile eye procedure kits with pouch packaging that may exhibit ... | Class II | Medline Industries, LP |
| Oct 3, 2025 | MC3 VitalFlow Console, REF 58100; Blood pump of ecmo | As of August 6, 2025, Medtronic has received eleven reports of VitalFlow Consoles displaying an E... | Class II | Medtronic Perfusion Systems |
| Oct 2, 2025 | Philips Azurion 7M20 systems with FlexArm ceiling-mounted system. Model Numb... | The motorized longitudinal movement of the FlexArm stand may be inconsistent (not smooth) and eve... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Oct 2, 2025 | IV Administration sets. 23" (58 cm) 150 mL Burette Set (Clave, Shut Off) w... | IV Gravity burette administration set burette component is missing an internal shutoff valve inte... | Class I | ICU Medical, Inc. |
| Oct 2, 2025 | CEREPAK Detachable Coil System - Name/REF: UNIFORM 2MM X 2.5 CM/FCX100202, UN... | Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke... | Class I | Cerenovus Inc |
| Oct 1, 2025 | DigitalDiagnost 4 (1) High Performance, (2) Flex/Value; Model Number: (1) 71... | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2... | Class II | Philips Medical Systems DMC GmbH |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider Nano Coated, Compatible ... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | MAGNETOM Cima.X Upgrade. Model Number: 11689304. | There is a potential for an ice blockage to form or currently exist within the primary and/or the... | Class I | Siemens Medical Solutions USA, Inc |
| Oct 1, 2025 | Beckman Coulter UniCel DxI 800, Part Numbers: 973100, A71456; Photometric Ch... | An internal investigation has determined that due to defective sub-components within the gantry a... | Class II | Beckman Coulter, Inc. |
| Oct 1, 2025 | Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product De... | Potential for contamination with cotton fibers. | Class II | ENDOMAGNETICS LTD |
| Oct 1, 2025 | Medline Renewal LigaSure Maryland Jaw Sealer/Divider NanoCoated, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | Class II | Medline Industries, LP |
| Oct 1, 2025 | Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control,... | The firm received complaints from customers reporting vial-to-vial variability when using the con... | Class II | Microgenics Corporation |
| Oct 1, 2025 | Medline Renewal LigaSure Impact Curved Large Jaw Sealer/Divider, Compatible w... | Medline Renewal has determined that certain areas on the device have the potential to trap residu... | 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.