Browse Device Recalls
39,949 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 39,949 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 39,949 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 13, 2025 | Allura Xper FD10C System Code: (1) 722001 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 Biplane OR Table System Code: (1) 722020 (2) 722025 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Cardio Vascular-Allura Centron; Catalog number: 722400 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10C; Catalog number: 722001 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10 - Catalog numbers: (1) 722003, (2) 722010, (3) 722026, | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/10; Catalog numbers: 722029 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M15 System Code: (1) 722064 (2) 722222 (3) 722280 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M12; Catalog numbers: (1) 722078, (2) 722223, (3) 722233 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B12; Catalog numbers: (1) 722067, (2) 722225, (3) 722235 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M12 System Code: (1) 722078 (2) 722223 (3) 722233 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/20 System Code: (1) 722038 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M20 System Code: (1) 722228 (2) 722232 (3) 722281 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD10 Catalog (1) 722003 (2) 722010 (3)722026 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B20; Catalog numbers: (1) 722068, (2) 722226, (3) 722236. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20 OR Table; Catalog numbers: (1) 722023, (2) 722035. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD10/10 System Code: (1) 722005 (2) 722011 (3) 722027 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M12 System Code: (1) 722227 (2) 722231 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXperFD20/15 System Code: (1) 722058 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 OR Table System Code: (1) 722023 (2) 722035 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 5 M12; Catalog numbers: (1) 722227, (2) 722231 (OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 ... | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20/15; Catalog numbers: 722058 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 Biplane System Code: (1) 722008 (2) 722013 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXperFD20/10 System Code: (1) 722029 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20 Biplane OR Table; Catalog numbers: (1) 722020, (2) 722025. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20; Catalog numbers: (1) 722006, (2) 722012, (3) 722028. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | AlluraXper FD20 System Code: (1) 722006 (2) 722012 (3) 722028 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B20 System Code: (1) 722068 (2) 722226 (3) 722236 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura CV20 System Code: 722031 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 B12 System Code: (1) 722067 (2) 722225 (3) 722235 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M12; Catalog numbers: (1) 722063, (2) 722221. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 7 M20; Catalog numbers: (1) 722079, (2) 722224, (3) 722234, (4) 72228... | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura CV20; Catalog numbers: 722031 | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY). | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Allura Xper FD20 Biplane; Catalog numbers: (1) 722008, (2) 722013. | Possibility of the patient falling from the table related to the mattress used on the patient table. | Class I | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 13, 2025 | Azurion 3 M12 System Code: (1) 722063 (2) 722221 | Potential safety issue with the AD7 and AD7X patient tables (both tilt and non-tilt versions) par... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Jan 10, 2025 | . Nobel Biocare N1 TiUltra TCC RP 4.0x9mm . Nobel Biocare N1 TiUltra TCC RP ... | Due to manufacturing issue (unintended by-product of the injection molding process) a sharp pin t... | Class II | Nobel Biocare |
| Jan 10, 2025 | BD Pyxis: MedFlex, REF: 1119-00; MedBank Tower REF: 1145-00; MedBank MedPass,... | Automated dispensing device labeling is being updated to strengthen labeling around manual access... | Class II | CareFusion 303, Inc. |
| Jan 10, 2025 | DxC 500 AU Clinical Chemistry Analyzer, REF: C63519, and C63520 with affected... | Beckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing t... | Class II | BECKMAN COULTER LABORATORY SYSTEMS (SUZHOU) CO.... |
| Jan 10, 2025 | Intact Vascular Tack Endovascular System, to treat vascular dissections with ... | Use of Tack Endovascular system, designed to treat acute dissections of inner wall or lining of a... | Class I | Spectranetics Corporation |
| Jan 10, 2025 | Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use ... | Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: ... | Class I | Fresenius Kabi USA, LLC |
| Jan 10, 2025 | Brand Name: MediHoney¿ Gel Product Name: MediHoney¿ Wound & Burn Dressing Ge... | Potential that the induction seal is not completely sealed to the device tube packaging. | Class II | Integra LifeSciences Corp. |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) CLOVIS RESP/INTUB DRAWER... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | A820 myPTM Software Application associated with Medtronic SynchroMed Pump and... | Product complaints were received describing the A820 myPTM app taking longer than expected for pa... | Class II | Medtronic Neuromodulation |
| Jan 9, 2025 | CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacteria... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 9, 2025 | Medline Convenience Kits for Various Procedures: 1) ADULT INTUBATION TRAY, M... | Kits contain recalled components due to reports of reduced skin barrier wear time. This refers to... | Class II | MEDLINE INDUSTRIES, LP - Northfield |
| Jan 9, 2025 | CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200... | The machine side connector of the filter HME may be occluded by plastic which prevents proper air... | Class II | Kung Shin Plastics Co. Ltd. |
| Jan 8, 2025 | stryker Precision Thin, Catalog Number REF 2296-003-108; Micro Oscillating an... | Precision Thin blade attachments have a potential to be out of measurement specifications, preven... | Class II | Stryker Corporation |
| Jan 8, 2025 | (1) BD Pyxis MedStation ES, Catalog No. 323; (2) BD Pyxis Anesthesia Station ... | Labeling is insufficient regarding delays in access to medication. The firm is strengthening the ... | Class II | CareFusion 303, Inc. |
| Jan 8, 2025 | The MSOT Acuity Echo is a Class 4 medical laser device. The MSOT Acuity is a ... | The MSOT Acuity Echo does not include an adequate instruction for safe operation of the device. T... | Class II | Ithera Medical Gmbh |
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.