Browse Device Recalls
3,664 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,664 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 3,664 FDA device recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A2, Model/REF Number 1012-9755-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650 A1, Model/REF Number 1012-9650-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 620 SE, Model/REF Number 1012-9620-012 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare Carestation 650 A1, Model/REF Number 1012-9650-200 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750 A1, Model/REF Number 1012-9750-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 750c A1, Model/REF Number 1012-9755-000 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 21, 2025 | GE Healthcare CARESTATION 650C A2, Model/REF Number 1012-9655-002 | GE HealthCare has become aware that certain Carestation 620/650/650c and 750/750c Anesthesia Deli... | Class I | GE Medical Systems China Co., Ltd. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 19, 2025 | Brand Name: Ballard Product Name: Closed Suction Catheters Model/Catalog Nu... | Lack of sterility assurance for closed suction catheter systems | Class I | Avanos Medical, Inc. |
| Mar 13, 2025 | HeartMate Mobile Power Unit: REF: 107754, NA; 107758, EU; 107758AU, AU; 10775... | Left Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cau... | Class I | Thoratec LLC |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: VentStar Product Name: VentStar Flex 220 Model/Catalog Number: ... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: ID Circuit Product Name: ID Circuit Flex 220 Model/Catalog Numb... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Novasight Hybrid System Product Name: Novasight Hybrid Catheter ... | Due to manufacturing issues there is a potential for the catheter sheath to detach. | Class I | Conavi Medical Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 12, 2025 | Brand Name: Anesthesia Circuit Kit Product Name: Anesthesia Circuit Kit Flex... | The potential for cracks forming in the breathing circuit hose. | Class I | Draeger, Inc. |
| Mar 11, 2025 | BD 4 Fr Single-Lumen PowerPICC Catheters, REF: 3174155, CK000540, 3174118, CK... | Catheters indicated for short-or-long term access to the central venous system have tubing that e... | Class I | Bard Access Systems, Inc. |
| Mar 4, 2025 | Brand Name: AutoPulse NXT Resuscitation System Product Name: AutoPulse NXT P... | AutoPulse NXT Resuscitation System may not provide adequate chest compressions or may stop compre... | Class I | ZOLL Circulation, Inc. |
| Feb 27, 2025 | t:slim X2 Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 27, 2025 | Tandem Mobi Insulin Pump with Interoperable Technology | A software defect in Version 7.9 of the pump software for Tandem t:slim X2 and Tandem Mobi pumps,... | Class I | Tandem Diabetes Care, Inc. |
| Feb 26, 2025 | Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tu... | Aspiration catheter distal tip features and characteristics may not be in the scope of FDA cleara... | Class I | Qapel Medical Inc. |
| Feb 26, 2025 | Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff Reusable Inner C... | Tracheostomy tube with cuff reusable inner cannula has a flange that may disconnect from the oute... | Class I | Covidien |
| Feb 24, 2025 | Medline medical convenience kits labeled as: 1) NEONATAL INTUBATION TRAY, ... | Specific Medline Kits were manufactured using Intubation ORAL/NASAL Endotracheal Tubes which were... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medical convenience kits containing Medtronic Aortic Root Cannula are being recalled due to the p... | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 21, 2025 | Medline medical procedure kits, containing Medtronic Aortic Root Cannula, lab... | Medline medical procedure kits, containing Medtronic Aortic Root Cannula | Class I | MEDLINE INDUSTRIES, LP - Northfield |
| Feb 19, 2025 | CVAC Aspiration System, REF: CVC127020-1, and User Manual L00018. Intended fo... | Aspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to ... | Class I | Calyxo, Inc. |
| Feb 18, 2025 | BD Care Coordination Engine (CCE) Infusion Adapter, Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p... | Class I | CareFusion 303, Inc. |
| Feb 18, 2025 | BD Alaris Systems Manager , REF 9601 Infusion Safety Management Software | Software issue that may result in outdated automated programming request(APR) being sent to the p... | Class I | CareFusion 303, Inc. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Cat... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Implantable Venous Acces... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Pol... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Ca... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 (... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyF... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, Inc. |
| Feb 13, 2025 | smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,... | The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate... | Class I | Smiths Medical ASD, 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.