Browse Device Recalls
38,509 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 38,509 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 38,509 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Sep 18, 2025 | Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Cat... | Software issue for hq analyzer results in system not visibly applying appropriate flagging to res... | Class II | Abbott Laboratories |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference... | Affected devices may contain PTFE coating scrapings. Scrapings could be released during device de... | Class I | Cook Medical Incorporated |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 266197 Salem Sump" Anti-... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 ... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 1180264408 Salem Sump" P... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 264929 Salem Sump" Stoma... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 18, 2025 | PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga. x 3-1/2 in... | Potential for the lid of the catheter connector to be in the incorrect position. | Class II | B BRAUN MEDICAL INC |
| Sep 18, 2025 | LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Mod... | The Ultrasound-Guided Attenuation Parameter (UGAP) measurement data may display inaccurate values... | Class II | GE Medical Systems, LLC |
| Sep 18, 2025 | Salem Sump PVC Tubes: Product Code/Product Name: 8888265108 Salem Sump Si... | Firm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force du... | Class II | Cardinal Health 200, LLC |
| Sep 17, 2025 | SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent, REF: 969706 | Beckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL... | Class II | Beckman Coulter Inc. |
| Sep 17, 2025 | MOSAIQ Oncology Information System Software Builds 3.1.3, 3.2.1, 3.2.2 & 3.... | When appending a care plan that contains one or more wave medication orders, the occurrence and ... | Class II | ELEKTA SOLUTIONS AB |
| Sep 17, 2025 | InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE PO... | InSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in f... | Class II | Enterix, Inc. |
| Sep 17, 2025 | Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: ... | IFU update; in-line valve, with pressure relief seal may leak when used with ventilator; don't us... | Class I | Percussionaire Corporation |
| Sep 17, 2025 | Fuse ULTRA Foot Plating System Instructions for Use. Models: OS200400, OS2... | Instructions for use for a foot plating system is being updated to remove the second option of re... | Class II | CPM Medical Consultants, LLC. |
| Sep 17, 2025 | Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp... | Affected oral/axillary probes were inadvertently programmed with the rectal probe configuration. ... | Class II | Baxter Healthcare Corporation |
| Sep 16, 2025 | Catalyft PL & PL40 Expandable Interbody System labeled as follows with corres... | Expandable interbody system cage may loose height or collapse (loss of lordosis), which could res... | Class II | Medtronic Sofamor Danek USA Inc |
| Sep 16, 2025 | SyncAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP)... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Brand Name: Sentinel V11 Product Name: Sentinel V11 Model/Catalog Number: 9... | Due to two distinct issues: 1. During patient admission, patient demographic fields may default ... | Class II | Spacelabs Healthcare, Ltd. |
| Sep 16, 2025 | Surgical Navigation Advanced Platform Patient Engagement (PE SNAP), software ... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Navigation Advanced Platform (SNAP), software version SNP.3.12.0, im... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Automated Impella Controller (AIC) labeled as the following with correspondin... | Potential for Automated Impella Controller (AIC) purge pressure issues due to purge retainer fail... | Class I | Abiomed, Inc. |
| Sep 16, 2025 | SpineAR Surgical Navigation Advanced Platform Patient Engagement (SyncAR SNAP... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Endo Surgical Navigation Advanced Platform Patient Engagement (EndoSNAP), sof... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | Surgical Planner, BrainSTORM, software version BST.9.3.0, orthopedic augmente... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 16, 2025 | SuRgical Planner (SRP), software version SRP.7.12.0, imaging processing radio... | A software anomaly, under specific conditions when large rotational alignment values are applied ... | Class II | Surgical Theater Inc |
| Sep 15, 2025 | FDR Visionary Suite, CH-200 Model/Version Numbers: (1) 566-16130-23, (2) 566... | It was found that the shaft for mounting the X-ray tube unit on the support may break. In additio... | Class II | FUJIFILM Healthcare Americas Corporation |
| Sep 15, 2025 | CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K, Description/REF: ... | XXX | Class II | Alcon Research LLC |
| Sep 12, 2025 | Optima NX; dual-head nuclear medicine gamma camera designed specifically for ... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Cardiac Workstation 7000; Model Number: 860441; | Failure of Environmental Stress Testing from a pinched power module wire within the housing of th... | Class II | Philips North America |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Maxicam; dual-head nuclear medicine gamma camera designed specifically for ca... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Elscint Cardial; dual-head nuclear medicine gamma camera designed specificall... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography a... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
| Sep 12, 2025 | Millenium MPS; dual-head nuclear medicine gamma camera designed specifically ... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Elscint Varicam; dual-head nuclear medicine gamma camera designed specificall... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Elscint SPX4; dual-head nuclear medicine gamma camera designed specifically f... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Sopha Medical Vision (SMV) DSXi/DST-XLi,/ DST-XL/ DSTi; dual-head nuclear med... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Elscint Helix; dual-head nuclear medicine gamma camera designed specifically ... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Starcam/Camstar; dual-head nuclear medicine gamma camera designed specificall... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Millenium Myosight; dual-head nuclear medicine gamma camera designed specific... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Product: STA Liatest D-Di; REF: 00515; | A potential risk of underestimation of D-Dimer (D-Di) levels with the two listed lots. | Class II | Diagnostica Stago, Inc. |
| Sep 12, 2025 | Millenium MG/MC; dual-head nuclear medicine gamma camera designed specificall... | GE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Gua... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Sep 12, 2025 | Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 0088633321... | Due to complaints of increased resistance when advancing the dilator within the introducer sheath... | Class II | Argon Medical Devices, Inc |
| Sep 12, 2025 | Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray Syst... | Third-party outer covers can become trapped between patient table and gantry, causing mechanical ... | Class II | UIH Technologies LLC |
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.