Browse Device Recalls
2,831 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,831 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 2,831 FDA device recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jan 15, 2025 | MOSAIQ Oncology Information System | Image offsets calculated by oncology Information System software may be incorrect for Linear A... | Class II | Elekta, Inc. |
| Jan 15, 2025 | DeRoyal AMG Suction Connector Tubing REF: 71-2083, 71-C506, 71-C510, 71-C... | The tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer con... | Class II | DeRoyal Industries Inc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX550. Model Number: 866066 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | Olympus Single Use Guide Sheath Kits with the following product descriptions ... | Potential for the radiopaque tip of the guide sheath component to disassociate and fall off into ... | Class I | Olympus Corporation of the Americas |
| Jan 15, 2025 | IntelliVue Patient Monitor MX450. Model Number: 866062 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | IntelliVue Patient Monitor MX400. Model Number: 866060 | Potential failure to alarm for "No Device Data" INOP. The device to alarm after a Hamilton venti... | Class II | Philips North America Llc |
| Jan 15, 2025 | ASP BIOTRACE Auto Read 60 Steam BI Process Challenge Device, REF 73135. | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the... | Class II | TERRAGENE S.A. |
| Jan 14, 2025 | Infinity Central Station. Model Number: MS26800 The Infinity CentralStatio... | Edifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mo... | Class II | Draeger Medical Systems, Inc. |
| Jan 13, 2025 | Allura Xper FD10/10; Catalog numbers: (1) 722005, (2) 722011, (3) 722027. | 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 5 M20; Catalog numbers: (1) 722228, (2) 722232 (OUS ONLY), (3) 722281... | 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 FD20/20; Catalog numbers: 722038 | 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 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.... |
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.