Browse Device Recalls
2,817 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,817 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 2,817 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Ring Transjugular Intrahepatic Access Sets, Reference Part Numbers: 1) RTP... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Semi Electric Lightweight Homecare Bed, REF MDR107002L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | R¿sch-Uchida Transjugular Liver Access Sets, Reference Part Numbers: RUPS-10... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007... | Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR m... | Class II | Remote Diagnostic Technologies Ltd. |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Lightweight Homecare Bed, REF MDR1... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E;... | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immun... | Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed... | Class II | Beckman Coulter, Inc. |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L | Medline Industries has identified a potential hazard involving the hand control pendant and assoc... | Class I | Medline Industries, LP |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 26, 2025 | Flexor Check-Flo Introducers and Sets, Reference Part Numbers: 1) KCFW-9.0... | Cook Medical identified that products supplied in the affected device lots may have been manufact... | Class II | Cook Incorporated |
| Nov 26, 2025 | Medline Kits containing B. Braun IV Administration Sets and Pump Administrati... | Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were reca... | Class II | Medline Industries, LP |
| Nov 25, 2025 | Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Ca... | Butyrate tube cracks during actuation, rendering product unusable. | Class II | Ferndale Laboratories, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impu... | Class I | Draeger, Inc. |
| Nov 24, 2025 | Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog... | Ophthalmic procedure packs may have incomplete seals affecting sterility. | Class I | Alcon Research LLC |
| Nov 24, 2025 | FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The F... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | Zimmer Dermatome AN, Model/Catalog Number: 88710100 | The devices may have a misaligned thickness control bar. | Class II | Zimmer Surgical Inc |
| Nov 24, 2025 | FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeSt... | Due to a manufacturing process issue that may cause carbon build up in the sensor that may result... | Class I | Abbott Diabetes Care, Inc. |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software... | Software issue only allows Concentration Limits to be defined to one digit of precision past the ... | Class II | ICU Medical, Inc. |
| Nov 24, 2025 | Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer. | A certain component of affected devices was not delivered within specification and contained impu... | Class I | Draeger, Inc. |
| Nov 24, 2025 | Zimmer Air Dermatome, Model/Catalog Number: 00880100100 | The devices may have a misaligned thickness control bar. | Class II | Zimmer Surgical Inc |
| Nov 24, 2025 | LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Softwar... | For certain customers, the Change Summary review option ceases to operate as expected for any mig... | Class II | ICU Medical, Inc. |
| Nov 24, 2025 | BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener. | Removal of affected lot of screws due to labeling error. | Class II | Smith & Nephew, Inc. |
| Nov 22, 2025 | Vivoo Vaginal pH Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Menopause Test Cassette (Urine) | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | LH One Step Ovulation Test Device (Urine) | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Vivoo pH Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED ... | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | S. Typhi/Para Typhi A Antigen | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PA... | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Vivoo Protein Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Exploro Highly Sensitive Male Fertility / Sperm Concentration Test | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 22, 2025 | Male Fertility Sperm Test for Home Use (Cassette) | Test strips and other tests including for near-patient testing, that require a 510(k) were distri... | Class II | Changchun Wancheng Bio-Electron Co., Ltd. |
| Nov 21, 2025 | The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay wit... | Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. ... | Class II | Roche Diagnostics Operations, Inc. |
| Nov 21, 2025 | Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005. | Emphasizing instructions for LVP duration programming located in the IFU. | Class II | Fresenius Kabi USA, LLC |
| Nov 21, 2025 | Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,... | Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occur... | Class II | Medline Industries, LP |
| Nov 20, 2025 | Restore Clinician Programmer Application (CP App), Model A71100 used with the... | Software issue where a Device Reset message displayed on the app was unable to be cleared. In rar... | Class II | Medtronic Neuromodulation |
| Nov 20, 2025 | BD Pyxis MedStation ES, REF: 323, BD Pyxis MedStation ES 7 Drawer Auxiliar... | Automated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which ca... | Class II | CareFusion 303, Inc. |
| Nov 19, 2025 | Vortex Surgical 25ga Illuminated Flex-Tip Laser Probe, Catalog Number VS0135.25; | Reason for the voluntary recall is some products in this lot are not passing through a 25ga cannu... | Class II | Vortex Surgical 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.