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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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. |
| Mar 29, 2024 | Stryker 1,5/1,7MM DYNAMIC MESH- STD-MEDIUM-Intended for the reconstruction, s... | Mislabeled: Product labeled 56-90614 (90x90 Gold Mesh), was actually 56-90314 (90x90 Blue Mesh), ... | Class II | Stryker Leibinger GmbH & Co. KG |
| Mar 29, 2024 | LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 29, 2024 | LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A ... | Due to unsupported 10 year expiration date. | Class II | CORENTEC CO., LTD |
| Mar 25, 2024 | RKN130003, RHEO KNEE 3 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKNXC0003, RHEO KNEE XC 3 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKNXC0005, RHEO KNEE XC 5 YR WARRANTY, MD, CE, External lower limb prosthetic... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 25, 2024 | RKN130002, RHEO KNEE 2 YR WARRANTY, MD, CE, External lower limb prosthetic co... | Due to firmware issues with the prosthetic knee, there is the potential for unintended warnings a... | Class II | Ossur H / F |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 6, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 7, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Innova IGS 5, computed tomography x-ray system | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 5 Pulse, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Interact Discovery RT, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 18, 2024 | GE Healthcare Allia IGS 7 OR, Interventional fluoroscopic x-ray systems | GE HealthCare has become aware of the potential that adhesive material might not have been applie... | Class II | GE Medical Systems, SCS |
| Mar 15, 2024 | PERLA TL 25D SCREW REF: TLF-DS 45 25-S TLF-DS 45 30-S TLF-DS 45 35-S TL... | Due to receiving information regarding difficulties with the insertion of a setscrew inside a scr... | Class II | SPINEART SA |
| Mar 13, 2024 | Brand Name: CLEANER BOTTLE Product Name: CLEANER BOTTLE Model/Catalog Numbe... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | Brand Name: PIEZON Bottle Product Name: PIEZON Bottle Model/Catalog Number:... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 13, 2024 | Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: E... | Received complaints that bottles assembled with one batch of bottle collars can be disassembled i... | Class II | Electro Medical Systems SA |
| Mar 5, 2024 | Clinical Chemistry Calibration Serum (Catalog number Cal2351) that is 20x5ml ... | Randox Laboratories has identified that Inorganic Phosphate in Calibration Serum Level 3, CAL2351... | Class II | Randox Laboratories Ltd. |
| Mar 4, 2024 | IBA Proton Therapy System - PROTEUS 235, PTS-10 versions, PTS-11 versions, an... | There is a risk of mistreatment as irradiation is not prevented when some safety parameters are o... | Class II | Ion Beam Applications S.A. |
| Feb 23, 2024 | RayStation Software Version Numbers version numbers 8B, 9A, 9B, 10A, 10B, 11A... | A use error that has occurred with RayStation/RayPlan, where material override using Silicon, Si,... | Class II | RAYSEARCH LABORATORIES AB |
| Feb 23, 2024 | Altair 330 lbs w/o Hanger Bar, REF: 55200H-NA, 55220H-NA, and Roomer S 220 kg... | Patient lift hanger bar may come loose, which could potentially pose risks to patients. | Class II | Human Care Hc Sweden Ab |
| Feb 14, 2024 | HeartSine samaritan PAD (Public Access Defibrillator): Type/Catalog: SAM 350P... | Automated external defibrillators were shipped in their test configuration so there is a potentia... | Class II | HeartSine Technologies Ltd |
| Feb 14, 2024 | Cystatin C Calibrator - In vitro diagnostic (IVD) use in the calibration of t... | Cystatin C Calibrator Series CVS 2699, is running with a negative bias compared to other methods | Class II | Randox Laboratories Ltd. |
| Feb 8, 2024 | Software VERIQA (S070031), version 2.0 and 2.1- Software package for display,... | Software: If the user excludes voxels from the Gamma calculation that are below a dose threshold ... | Class II | PTW-FREIBURG |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | Azurion 5 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | SPII Model Lubinus, Hip Prosthesis Stem Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | Azurion 3 with a Certeray generator -To perform image guidance in diagnostic,... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 6, 2024 | Azurion 7 with a Certeray generator-To perform image guidance in diagnostic, ... | Generator may fail due to a potential short circuit in the Printed Circuit Board Assembly (PCBA) ... | Class II | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
| Feb 6, 2024 | SPII Model Lubinus, Long Stem Prosthesis XL Neck, cemented | Due to two complaints, has come to our attention that additional guidance is required on the corr... | Class II | Waldemar Link GmbH & Co. KG (Mfg Site) |
| Feb 2, 2024 | CERENOVUS CEREBASE DA Guide Sheath, Part Numbers: a) GS9080SD; b) GS909... | Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractur... | Class I | Medos International Sarl |
| Jan 29, 2024 | Shimadzu, Trinias, Digital Angiography System | Due to capacitor manufacturing issue, their is a potential that Flat Panel Device may have abnorm... | Class II | SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION |
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.