Browse Device Recalls

2,115 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,115 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 2,115 FDA device recalls in N/A.

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DateProductReasonClassFirm
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation -Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
Jan 16, 2025 Brand Name: RayStation- Intended as a Radiation Therapy Treatment Planning Sy... Inconsistency in the use of Density uncertainty in the RayStation functions Robust optimization, ... Class II RAYSEARCH LABORATORIES AB
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 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 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 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 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 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 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 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 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 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....
Oct 16, 2024 CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical Matrix... Retroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical mat... Class II CORNEAT VISION, LTD.
Oct 15, 2024 OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor t... Battery movement led to damage of one of the battery cells causing it to short to the battery ret... Class II OrganOx Ltd
Oct 10, 2024 Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software... A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calc... Class II Philips Medical Systems Technologies Ltd.
Oct 8, 2024 MONOCRYL" (poliglecaprone 25) Suture REF Y936H MONOCRYL" Sutures are indic... Due a component mix-up in manufacturing, the affected products may contain incorrect needle type/... Class II ETHICON, INC.
Oct 7, 2024 Philips Zenition 70, Model Number: 718133 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Oct 7, 2024 Philips Zenition 50, Model Number: 718096 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a p... Class II PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Sep 25, 2024 Elekta Disposable Biopsy Needle Kit for Leksell Stereotactic System, REF 9119... Elekta has become aware that Disposable Biopsy Needles can contain some microscopic debris on the... Class I Elekta Instrument AB
Sep 24, 2024 REF: 99-709245, Fitbone Trochanteric Nail L245mm, D9mm, Sterile Retrospective; Their is the potential that implantable intramedullary lengthening nails may bend... Class II Orthofix Srl
Sep 6, 2024 The FLUOROspeed is intended to be used as a universal diagnostic imaging syst... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 Trinias unity, Digital Angiography System with Catheterization Table, Model: ... If digital angiography system is used with a specific catheterization table and the operator dire... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 6, 2024 SONIALVISION G4 is a multi-purpose X-ray R/F system. The equipment is suitabl... X-ray R/F system software with certain versions of the control board may occasionally fail to dis... Class II SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
Sep 4, 2024 bk3000, model #2300-11; bk3500, model #2300-41; bk5000, model #2300-61; and b... The internal power connections at the power inlet of the ultrasound devices can come loose result... Class II B-K Medical A/S
Aug 30, 2024 Predict+ is a data-driven, clinical decision support tool that uses machine l... Predict+ is being recalled for lack of pre-market clearance/approval. Class II Blue Ortho
Aug 20, 2024 Miami J Select Collar, Catalog: MJS-101; Miami J Select Collar Set, Catalog: ... Pressure sensitive adhesive hooks attached to the sides of the anterior cervical orthosis collar ... Class II Ossur H / F
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 26, 2024 DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number... The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the ... Class II FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 26, 2024 ARTIS is a family of dedicated angiography systems developed for single and b... A potential issue with ARTIS icono systems equipped with a small detector and a corresponding col... Class II Siemens AG/Siemens Healthcare GmbH
Jun 5, 2024 DxC 500 AU Clinical Chemistry Analyzer, REF C63520 is an automated chemist... There are two software bug issues with the analyzer. Issue 1: When a dedicated rack is reserved f... Class II Beckman Coulter Mishima K.K.
May 24, 2024 WOM Tube Set for lrrlgatlon, single-use- Intended to transport irrigation flu... Incorrect transponder data was written on the RFID tags triggers the error message E03, Tube Set... Class II WOM World Of Medicine AG
May 15, 2024 Ventilator HAMILTON-C6, PN: 160021 Ventilator may enter sensor fail mode, ventilation may not re-initiate, after patient is reconnec... Class I Hamilton Medical AG

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.