Browse Device Recalls
2,479 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,479 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 2,479 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 5, 2025 | stryker Blueprint Mixed Reality Glenoid Digitizer, Catalog Number MRUE201, pa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 5, 2025 | stryker Blueprint Mixed Reality Coracoid Clamp, Catalog Number MRUE202, packa... | Stryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed R... | Class II | Tornier S.A.S. |
| Mar 4, 2025 | InPen smart insulin pen, REF: MMT-105NNBLNA, MMT-105NNGYNA, MMT-105NNPKNA, MM... | Insulin pens may have been incorrectly assembled therefore users could experience the following: ... | Class II | Medtronic MiniMed, Inc. |
| Mar 3, 2025 | Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK N... | There is a potential for open/weak seals on purchased breather pouches used for packaging of sele... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 24, 2025 | COR Disposable Kit, 8 mm w/ Perpendicularity. Cartilage Transplant System. | Device is missing the pin in the graft loader component. | Class II | DePuy Mitek, Inc., a Johnson & Johnson Co. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 17, 2025 | Microstream Instructions for Use and Part Number used with - Product Descript... | Neonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/I... | Class II | Oridion Medical 1987 Ltd. |
| Feb 15, 2025 | Aveir DR Leadless Pacemaker (LP) Ventricular Device REF LSP202V UDI-DI code... | Due to a manufacturing issue, leadless pacemakers may have been exposed to higher than normal tem... | Class II | Abbott Medical |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: G5S-... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Feb 13, 2025 | Brand Name: ZOLL Product Name: Powerheart G5 AED Model/Catalog Number: (1) ... | The potential for devices to fail their self-test as a result of prolonged exposure to extreme en... | Class II | ZOLL Medical Corporation |
| Jan 31, 2025 | DeRoyal REF 71-C5100NS Tubing, Suction, Connector; DeRoyal REF 71-C6100NS Tu... | Due to the inner diameter of the suction tubing connector being smaller than the suction canister... | Class II | DeRoyal Industries Inc |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Jan 6, 2025 | NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F ... | It was identified internally that two commingle events occurred where the metal support post with... | Class II | Zimmer, Inc. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Right Angle Valve Only. Model Number: 8... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 16, 2024 | CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only. Model Number: ... | Potential for certain SKUs and lot numbers were distributed with the incorrect product descriptio... | Class II | Integra LifeSciences Corp. |
| Dec 10, 2024 | Medtronic NanoCross Elite PTA catheter, REF numbers amd sizes: 1) AB14W0... | There is the potential for in-vivo balloon deflation issues, including difficulty or inability to... | Class II | ev3 Inc |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Nov 6, 2024 | ChemoLock Close Vial Spike REF CL-80 The Chemolock Closed System Transfer ... | Due to finished goods incorrectly packaged and labeled. | Class II | ICU Medical, Inc. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography s... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed t... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tom... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/comput... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/comp... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | NOA Medical Industries Behavioral Health Hospital bed side rails, Product num... | Red button used to engage side rails can break or become stuck making it difficult to engage the ... | Class II | NOA Medical Industries Inc |
| Nov 5, 2024 | GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomograph... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
| Nov 5, 2024 | GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomogr... | GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution seri... | Class II | GE Healthcare (China) Co., Ltd. |
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.