Browse Device Recalls
2,049 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 2,049 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 2,049 FDA device recalls in N/A.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 |
| May 10, 2024 | IBA Proton Therapy System - PROTEUS 235 - Designed to produce and deliver a p... | Irradiation is not interrupted when some C230 Accelerator Control Unit critical parameters are ou... | Class II | Ion Beam Applications S.A. |
| May 9, 2024 | Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempu... | Simultaneous ECG measurements with multiple devices, including a manual defibrillator, on the sam... | Class II | Remote Diagnostic Technologies Ltd. |
| May 2, 2024 | GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) ... | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... | Class II | GE Vingmed Ultrasound As |
| May 2, 2024 | GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SW | GE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a ... | Class II | GE Vingmed Ultrasound As |
| Apr 24, 2024 | MNA-420 ENC HDMI, Material Number K9303311; cathode ray tube display | We have identified a potential issue with the SFP+ module supplied by Molex (Part Number: B620050... | Class II | Barco N.V. |
| Apr 18, 2024 | Alaris Pump Infusion Set Low Sorbing Tubing (PE Lined) Back Check Valve 2 Sma... | Due to infusion set tubing drip chamber becoming detached from the tubing potentially causing del... | Class II | BD SWITZERLAND SARL |
| Apr 17, 2024 | Intelli-C: Right side suspended Tabletop, REF: 03400000; Left side suspended ... | X-ray system C-arm may experience uncontrolled motion if 1) AC motor controller firmware has a fa... | Class II | NRT X-RAY A/S |
| Apr 15, 2024 | MyoSPECT System, Model H3912AA and H3912B, and MyoSPECT ES System, Model H39... | There is a potential issue regarding the service handles for the internal lead (Pb) covers in tha... | Class II | GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
| Apr 10, 2024 | Leica HistoCore PEGASUS Tissue Processor, REF 14048858005. | Poorly processed and/or damaged biopsy tissue specimens on the device resulting from reagent leve... | Class II | LEICA BIOSYSTEMS NUSSLOCH GMBH |
| Apr 9, 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... | Class II | Sophysa S.A. |
| Apr 9, 2024 | The Sophysa Pressio¿ Ventricular Intracranial Pressure Monitoring Kit monitor... | An increase in claims related to leakage of cerebrospinal fluid (CSF) from the proximal end of th... | Class II | Sophysa S.A. |
| Apr 8, 2024 | Vyaire Medical GmbH, Vyaire Twin Tube sample line 240 cm, Model Number V-7073... | Potential of the nozzle separating during patient use. | Class I | Vyaire Medical, Inc. |
| Apr 8, 2024 | HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 36... | Automated external defibrillators have a manufacturing issue that could prevent the device from d... | Class II | HeartSine Technologies Ltd |
| Apr 5, 2024 | Evidence MultiSTAT with software v 3.7-Analyzer intended for the qualitative ... | Foam gasket on the Evidence MultiSTAT chip heater assembly may not perform as expected. Foam that... | Class III | Randox Laboratories Ltd. |
| Apr 4, 2024 | Reagent Test Strips for Blood, Urobilinogen, Bilirubin, Protein, Nitrite, Ket... | The reason for the recall is one of the test pads, for the parameter leukocytes, was missing on s... | Class II | Macherey Nagel Gmbh & Co. Kg |
| Apr 2, 2024 | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US | Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured befor... | Class II | Fisher & Paykel Healthcare, Ltd. |
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.