Browse Device Recalls
3,089 FDA medical device safety recalls.
FDA Medical Device Recall Enforcement Database
Browse 3,089 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 3,089 FDA device recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 13, 2024 | Brand Name: Tacy Medical, Inc. Product Name: Dressing Change Tray CS/20 Mod... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Transparent Dres... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Dressing Change Kit with Cloth Border Teg... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep ... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 13, 2024 | Brand Name: Wolf-Pak Product Name: Premium Dressing Change Kit with GuardiVa... | Potential for hole in package compromising sterility of the medical kit. | Class II | Trinity Sterile, Inc. |
| Dec 6, 2024 | Portrait Core Services, a set of software services that enable the communicat... | There is a software issue that can result in the loss of patient monitoring on the Portrait Centr... | Class II | GE Medical Systems, LLC |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 5, 2024 | Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Product... | Hemoglobin interference may occur at concentrations lower than the claimed 300 mg/dL, and may cau... | Class II | QUIDEL ORTHO |
| Dec 3, 2024 | UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW300... | Due to software anomalies that may impact on rod planning specifically, certain optional surgical... | Class II | Medicrea International |
| Dec 2, 2024 | Change Healthcare Cardiology Hemodynamics software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | McKesson Cardiology Hemo software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Dec 2, 2024 | Change Healthcare Cardiology Hemo software | Software defect concerning autosave mechanism may result in the clinician administering incorrect... | Class II | A L I Technologies Ltd |
| Nov 26, 2024 | Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 882... | Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging. | Class II | O&M HALYARD, INC. |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Xhibit Telemetry Receiver with Software, Model 96280. Intended to provide mo... | Telemetry receivers with affected software versions may experience unsolicited system shut down a... | Class II | Spacelabs Healthcare, Inc. |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 25, 2024 | Brand Name: Olympus Thunderbeat Front-Actuated Grip Type S Hand Instrument P... | The probe tips of the hand instruments are being damaged or breaking including pad damage and det... | Class II | Olympus Corporation of the Americas |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Ver... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Versi... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 22, 2024 | epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version... | Siemens Healthcare Diagnostics is recalling their epoc Blood Analysis System because of a softwar... | Class II | Siemens Healthcare Diagnostics, Inc. |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model ... | Due to a programmer software anomaly, during finalizing of the leadless pacemaker system, a speci... | Class II | Abbott Medical |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 21, 2024 | SynchroMed II Model 8637 and SynchroMed III Model 8667 implantable pumps used... | Software issues were identified in application version 2.x. | Class II | Medtronic Neuromodulation |
| Nov 20, 2024 | StatStrip Glucose Ketone Hospital Meter System. Model/Catalog Number: 63683. ... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | StatStrip Glucose Ketone (mmol/L) Hospital Meter System. Model/Catalog Number... | A software bug within the meter firmware leads to transmission of erroneous glucose and/or ketone... | Class I | Nova Biomedical Corporation |
| Nov 20, 2024 | Philips Smart-Hopping 2.0 AP 1.4 GHz. Model Number: 867216 | The following four issues are included: 1. Certain Channel Settings may result in an Access Poi... | Class II | Philips North America Llc |
| Nov 20, 2024 | StatStrip Glucose Hospital Meter System. Model/Catalog Number: 63685. Prescri... | A software bug within the Gen 2 StatStrip Hospital Meter firmware leads to transmission of errone... | Class I | Nova Biomedical Corporation |
| Nov 16, 2024 | Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344. | Potential for a plan box not updated issue during Interventional procedure with Spectral CT that ... | Class II | Philips North America Llc |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: R65 Trolley Model/Catalog Number: K2401... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: Multiple/unknown Model/Catalog Number: ... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.10.0 and 3.10.1. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | mint Lesion, Software Versions: 3.9.0 through 3.9.5. | Some software versions have a malfunction where they may show incorrect orientation labels for a... | Class II | Mint Medical GmbH |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: T47 Warming Plate Model/Catalog Number:... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
| Nov 15, 2024 | Brand Name: K-Systems Product Name: G85 Mini Incubator Model/Catalog Number... | The warming surfaces or incubator well temperatures of the listed products may exceed the desired... | Class II | CooperSurgical, Inc. |
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.