Device recalls
Device recalls with the root cause, the firm, the products and the recall status. 59,705 records; openFDA updated it 2026-11-13. About this dataset
Newest records
- Other8,928
- Device Design7,678
- Under Investigation by firm7,031
- Process control6,625
- Nonconforming Material/Component5,990
- Software design3,532
- Packaging1,667
- Component design/selection1,611
- Cardinal Health Presource PBDS kits, Containing BD Alaris Pump Infusion Sets used with BD Alaris Pump Module Model 8100, labeled as: KIT EM…FDA page
Cardinal Health 200, LLC · Kits contain infusion sets which were recalled for performance issues.
- Generic Name: Edwards Commander M Delivery System Generic Name: Edwards Commander M Delivery System Model/Catalog Number: 9880CM29A Softwar…FDA page
Edwards Lifesciences, LLC · Due to a manufacturing issue which may result in cardiovascular balloon rupturing.
- Tandem Mobi Insulin Pump, Models: 1004004, 1010750, 1012676, 1012719, 1013655, 1013656, 1013501, 1013700, 1014081, 1014801, 1014811, 101481…FDA page
Tandem Diabetes Care, Inc. · Tandem Diabetes Care, Inc. ( Tandem ) has identified that certain Tandem Mobi insulin pumps may generate false-positive occlusion alarms when no actual insulin…
- Hemochron Jr., Whole Blood Microcoagulation System, Activated Partial Thromboplastin Time (APTT) Test Cuvette, REF: J103FDA page
Accriva Diagnostics, Inc. · Microcoagulation test used to evaluate low dose heparin anticoagulation has a mispositioned or absent clot activating reagent, which may result in out-of-range…
- EVOS 3.5MM LATERAL PROXIMAL TIBIA PLATE 6 HOLE LEFT 91MM REF72463106FDA page
Smith & Nephew, Inc. · Incorrect labeling; 3.5MM Partial Articular Lateral Proximal Tibia Plate 6 hole Left 91MM implant labeled and lasered etched as as 3.5MM Lateral Proximal Tibia…
- Embletta MPR PG Multi Parameter Recorder Sleep Monitor, Model/Catalog Number: 2003011FDA page
NATUS MEDICAL INCORPORATED · The device may be unable to correctly format its internal memory. When the internal memory cannot be correctly formatted, previously recorded studies may remai…
- Nextseq 550Dx Instrument REF: 20005715, FOR IN VITRO DIAGNOSTIC USEFDA page
Illumina, Inc. · (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serv…
- MiSeq Dx Instrument REF: DX-410-1001 / 15036706, FOR IN VITRO DIAGNOSTIC USEFDA page
Illumina, Inc. · (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serv…
- NovaSeq 6000Dx Instrument REF: 20068232, FOR IN VITRO DIAGNOSTIC USEFDA page
Illumina, Inc. · (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serv…
- Illumina DRAGEN Server for NextSeq 550Dx REF: 20086130,FDA page
Illumina, Inc. · (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serv…
- VeriSeq Onsite Server V2 REF: 20047000FDA page
Illumina, Inc. · (Retrospectively reported) Cybersecurity vulnerability identified in communication protocol between the customer-provided infrastructure (network storage, serv…
- CryoPatch SynerGraft (SG) Pulmonary Human Cardiac Patch, Model: SGP010FDA page
Artivion, Inc · A cryopreserved pulmonary human cardiac patch, taken from a 64-year-old human donor, was outside the cardiac tissue donor age specification of newborn to 60 ye…
- Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation SystemFDA page
Boston Scientific Neuromodulation Corporation · Therapy Disc (TD) that powers and sends stimulation signals to an Implantable Pulse Generator (IPG), part of a neurostimulation system, has a firmware issue th…
- Precision Pointer Electromagnetic (8000-050-001)FDA page
Stryker Leibinger GmbH & Co. KG · Device may fracture during use at the laser welded joint on the pointer tube. If this happens, loose parts may fall out of the product while the device is insi…
- Carevo, Height-adjustable shower trolley, Model Number BAC1111-01FDA page
ARJOHUNTLEIGH POLSKA Sp. z.o.o. · The side support of the shower trolley may open unintentionally when the handles are not fully locked and additional force is applied during patient handling.…
- Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.FDA page
Abiomed, Inc. · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may…
- Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.FDA page
Abiomed, Inc. · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may…
- Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.FDA page
Abiomed, Inc. · Retrospective review of servicing records identified AIC units requiring various hardware, firmware, and/or software update(s): 1. RFID firmware issue that may…
- PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.FDA page
Pentax of America Inc · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during th…
- PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.FDA page
Pentax of America Inc · Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during th…
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.