{"count":30,"events":[{"source":"fda_device","external_id":"Z-0208-2027","category":"product_recall","title":"DEVICE: Automated Impella Controller, Packaged. Primary user control interface for the Impella Catheter, catheter-based heart pump.","summary":"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 result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy.   2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console.   3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange.   4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0208-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028241+00:00","last_seen":"2026-11-11T01:19:07.283512+00:00","region":"MA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0209-2027","category":"product_recall","title":"DEVICE: Impella Optical Controller, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.","summary":"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 result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy.   2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console.   3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange.   4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0209-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028332+00:00","last_seen":"2026-11-11T01:19:07.283662+00:00","region":"MA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0210-2027","category":"product_recall","title":"DEVICE: Impella Connect Optical AIC, Packaged. Primary user control interface for the Impella Catheter, a catheter-based heart pump.","summary":"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 result in failure of the AIC to recognize the purge cassette during case setup or cassette change. This issue may result in delay in procedure or therapy.   2. Potential for the rotary push button (RPB) sticking and unreliable actuation impacting operator ability to select and confirm menu entries. This can result in loss of control of the console.   3. Potential AIC instability that could result in AIC start-up failure, inability to drive the pump, and the need for console exchange.   4. Software defect related to calculator process crash, leading to Negative Central Venous Pressure (CVP) values present in Pulmonary Artery Pressure (PAP) calculations.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0210-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028350+00:00","last_seen":"2026-11-11T01:19:07.283693+00:00","region":"MA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0284-2027","category":"product_recall","title":"DEVICE: ETHILON Nylon Suture, Product Code 697G","summary":"Ethicon, LLC — Nylon suture indicated for use in general soft tissue approximation and/or ligation may have needles with distorted curvature, that may break during use, or could cause additional soft tissue or vessel injury, including tearing or bleeding intraoperatively.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0284-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028472+00:00","last_seen":"2026-11-11T01:19:07.283928+00:00","region":"PR","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0285-2027","category":"product_recall","title":"DEVICE: OmniaSecure Model 3930M,    LEAD 3930M74 74 CM DF4 MR  3930M74    LEAD 3930M79 79 CM DF4 MR  3930M79    The Medtronic OmniaSecure\" Model 3930M lead is a steroid eluting,  integrated bipolar,","summary":"Medtronic, Inc. — Affected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential harm of tissue trauma due to implant difficulty.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0285-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.027935+00:00","last_seen":"2026-11-11T01:19:07.283345+00:00","region":"MN","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0286-2027","category":"product_recall","title":"DEVICE: Orthoscan VERSA Accessory Cart, REF: 1000-0021 and Versa Mini C-Arm System, REF: 1000-0020","summary":"ZIEHM-ORTHOSCAN INC — The accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure from the cart.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0286-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028839+00:00","last_seen":"2026-11-11T01:19:07.284218+00:00","region":"AZ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0288-2027","category":"product_recall","title":"DEVICE: Model Number: 712010.","summary":"Philips North America — Potential for the device to fail immediately after an exposure, causing the system to remain stationary.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0288-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028632+00:00","last_seen":"2026-11-11T01:19:07.284036+00:00","region":"MA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0289-2027","category":"product_recall","title":"DEVICE: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM    REF: INFX-8000C","summary":"Canon Medical System, USA, INC. — Due to software issue, X-ray interventional  system  may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0289-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028402+00:00","last_seen":"2026-11-11T01:19:07.283756+00:00","region":"CA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0290-2027","category":"product_recall","title":"DEVICE: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM    REF: INFX-8000F","summary":"Canon Medical System, USA, INC. — Due to software issue, X-ray interventional  system  may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0290-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028297+00:00","last_seen":"2026-11-11T01:19:07.283603+00:00","region":"CA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0291-2027","category":"product_recall","title":"DEVICE: ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM    REF: INFX-8000V","summary":"Canon Medical System, USA, INC. — Due to software issue, X-ray interventional  system  may experience internal error if F-Store or imagine acquisition is performed while clinical analysis function is use.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0291-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028573+00:00","last_seen":"2026-11-11T01:19:07.284001+00:00","region":"CA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0292-2027","category":"product_recall","title":"DEVICE: Philips Azurion 3 M12. Model Numbers: 722063, 722221.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0292-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028677+00:00","last_seen":"2026-11-11T01:19:07.284087+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0294-2027","category":"product_recall","title":"DEVICE: Philips Azurion 5 M12. Model Number: 722227.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0294-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028275+00:00","last_seen":"2026-11-11T01:19:07.283569+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0295-2027","category":"product_recall","title":"DEVICE: Philips Azurion 5 M20. Model Numbers: 722228, 722281.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0295-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028369+00:00","last_seen":"2026-11-11T01:19:07.283715+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0296-2027","category":"product_recall","title":"DEVICE: Philips Azurion 7 B12. Model Numbers: 722067, 722225.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0296-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028785+00:00","last_seen":"2026-11-11T01:19:07.284200+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0297-2027","category":"product_recall","title":"DEVICE: Philips Azurion 7 B20. Model Numbers: 722068, 722226.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0297-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028517+00:00","last_seen":"2026-11-11T01:19:07.283983+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0298-2027","category":"product_recall","title":"DEVICE: Philips Azurion 7 M12. Model Numbers: 722078, 722223.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0298-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028609+00:00","last_seen":"2026-11-11T01:19:07.284018+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0299-2027","category":"product_recall","title":"DEVICE: Philips Azurion 7 M20. Model Numbers: 722079, 722224, 722282.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0299-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028749+00:00","last_seen":"2026-11-11T01:19:07.284165+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0300-2027","category":"product_recall","title":"DEVICE: Philips Azurion S. Model Number: 722285.","summary":"PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. — Solid-State Drives (SSDs) that are not specified in the Medical Device File may have been installed in various PCs. These SSDs may have different performance characteristics, which may include reduced reliability over time such as loss of imaging functionality or motorized movement, a blank or black display, and/or the inability to store newly acquired images or access previously acquired images.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0300-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028386+00:00","last_seen":"2026-11-11T01:19:07.283734+00:00","region":"Netherlands","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0301-2027","category":"product_recall","title":"DEVICE: EMAG system  Model/Catalog Number: 418591/418591U  Product Description: Nucleic acid sample preparation instrument IVD, automated","summary":"BioMerieux SA — Delayed or no result when analyzing clinical samples with EMAG system (ref: 418591/418591U) due to a randomly occurring software error, Error 10003 Heater timeout after updating to recent firmware SP4 Patch 2","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0301-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028455+00:00","last_seen":"2026-11-11T01:19:07.283896+00:00","region":"France","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0302-2027","category":"product_recall","title":"DEVICE: CareLink SmartSync Programmer, Model 24970A, Pulse generator, permanent, implantable","summary":"Medtronic, Inc. — Software problem has the potential for an inaccurate displayed longevity estimate.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0302-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028316+00:00","last_seen":"2026-11-11T01:19:07.283640+00:00","region":"MN","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0303-2027","category":"product_recall","title":"DEVICE: CareLink SmartSync, RF Head Patient Connector, Model 24967, Pulse generator, permanent, implantable","summary":"Medtronic, Inc. — Software problem has the potential for an inaccurate displayed longevity estimate.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0303-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028436+00:00","last_seen":"2026-11-11T01:19:07.283858+00:00","region":"MN","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0304-2027","category":"product_recall","title":"DEVICE: CareLink SmartSync Device Manager App, Model M01A02, Pulse generator, permanent, implantable","summary":"Medtronic, Inc. — Software problem has the potential for an inaccurate displayed longevity estimate.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0304-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028503+00:00","last_seen":"2026-11-11T01:19:07.283966+00:00","region":"MN","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0306-2027","category":"product_recall","title":"DEVICE: PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR.","summary":"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 the procedure.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0306-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028693+00:00","last_seen":"2026-11-11T01:19:07.284104+00:00","region":"NJ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0307-2027","category":"product_recall","title":"DEVICE: PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U.","summary":"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 the procedure.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0307-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028765+00:00","last_seen":"2026-11-11T01:19:07.284183+00:00","region":"NJ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0308-2027","category":"product_recall","title":"DEVICE: PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK.","summary":"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 the procedure.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0308-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028488+00:00","last_seen":"2026-11-11T01:19:07.283948+00:00","region":"NJ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0309-2027","category":"product_recall","title":"DEVICE: PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK.","summary":"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 the procedure.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0309-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028708+00:00","last_seen":"2026-11-11T01:19:07.284120+00:00","region":"NJ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0310-2027","category":"product_recall","title":"DEVICE: PENTAX Medical Water bottle assembly. Model Number. OS-H5.","summary":"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 the procedure.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0310-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028648+00:00","last_seen":"2026-11-11T01:19:07.284053+00:00","region":"NJ","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0311-2027","category":"product_recall","title":"DEVICE: Nalu TD2 Therapy Disc with firmware, REF: 34014-001, and TD2 Patient Kit, REF: 74011, part of the Nalu Neurostimulation System","summary":"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 that causes the TD to attempt to restart, then fail, leading it to become non-functional, and if a secondary TD is unavailable, this may lead IPG to become non-functional, thus unable to inhibit transmission of pain signals.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0311-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028420+00:00","last_seen":"2026-11-11T01:19:07.283809+00:00","region":"CA","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0314-2027","category":"product_recall","title":"DEVICE: Precision Pointer Electromagnetic (8000-050-001)","summary":"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 inside the patient.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0314-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028663+00:00","last_seen":"2026-11-11T01:19:07.284069+00:00","region":"Germany","lat":null,"lon":null},{"source":"fda_device","external_id":"Z-0315-2027","category":"product_recall","title":"DEVICE: Carevo, Height-adjustable shower trolley, Model Number BAC1111-01","summary":"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. If the side support is not fully locked and an additional force is applied by the caregiver on the handle (e.g., during turning or repositioning), the panel may open unintentionally, which can lead to a resident/patient fall and serious injury, such as head injury, fractures, or other trauma resulting from a patient fall.","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0315-2027%22","event_at":"20261104","first_seen":"2026-11-10T07:12:10.028722+00:00","last_seen":"2026-11-11T01:19:07.284137+00:00","region":"Poland","lat":null,"lon":null}],"limitations":"Source records are incidents, alerts or recall notices, not verified plant shutdowns or product shortages."}