Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 101 - 125 of 210 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Product Name: ID NOW" Influenza A & B 2 Model/Catalog Number: 427-000 Software Version: Not Applicable Product Description: Influenza A/B virus nucleic acid IVD, kit, nucleic acid technique Component: Not Applicable It was confirmed that the impacted lot has a higher occurrence of invalid rates when compared to the product Instructions for Use.	FDA Z-1565-2026	Medical Device	High	Mar 25, 2026 Recall: Feb 9, 2026	Details
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150 There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.	FDA Z-1571-2026	Medical Device	High	Mar 25, 2026 Recall: Jan 30, 2026	Details
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.	FDA Z-1570-2026	Medical Device	High	Mar 25, 2026 Recall: Jan 30, 2026	Details
Brand Name: APTUS Product Name: 2.8 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5850.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	FDA Z-1550-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 9, 2026	Details
HealthCast "Vital Sync" Remote Patient Monitoring System which consists of: Product Number: VSLBASE03P / VITALSYNCSW03 Model / UDI-DI codes: Vital Sync 3.3.1 / 10884521844933 Vital Sync 3.4.0 / 10884521844940 Vital Sync 3.4.1 / 10884521847569 (OUS Only) Vital Sync 3.4.2 / 10884521856127 Product Number: VSLBASE04P / VITALSYNCSW04 Model / UDI-DI codes: Vital Sync 4.0.0 / 10884521849358 Vital Sync 4.0.2 / 10884521856134 The Vital Sync" Informatics Manager is software that is intended to route and store medical device data and device diagnostic information from supported devices to the Virtual Pat Due to complaints and investigations stating that alarms from the primary patient bedside monitor was not alarming/being transmitted and received on the remote patient monitoring system.	FDA Z-1557-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
Brand Name: APTUS Product Name: 2.5 TriLock Screw 16mm, HD7, 1/Pkg Model/Catalog Number: A-5750.16/1 Software Version: Not applicable. Product Description: The APTUS fixation systems are used for fractures, osteotomies and arthrodesis of the hand, forearm, shoulder and foot. Component: Not applicable. Mix up between specified lots of 2.5mm and 2.8mm outer diameter screws.	FDA Z-1549-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 9, 2026	Details
DxC 700 AU, REF: B86444, B86446 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment.	FDA Z-1552-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281 A delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open beyond15 minutes may lead to: Reagent Blank and calibration databases not opening errors: CAL History DB Open Error.., RB History DB Open Error..; system will stop analyzing, firm service must visit to apply software solution; may lead to delay in diagnosis and/or patient treatment	FDA Z-1553-2026	Medical Device	High	Mar 18, 2026 Recall: Jan 30, 2026	Details
Brand Name: B. Braun Product Name: BBraun Medical 21G X4.4CM Winged INF Model/Catalog Number: 7B3050 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	FDA Z-1481-2026	Medical Device	High	Mar 11, 2026 Recall: Feb 2, 2026	Details
Brand Name: B. Braun Product Name: 21GA WINGED INFUSION, SINGLE PK Model/Catalog Number: 7A3842 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	FDA Z-1482-2026	Medical Device	High	Mar 11, 2026 Recall: Feb 2, 2026	Details
CS100 IABP. Software Version CS100 IABP Q.01. The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.	FDA Z-1486-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 23, 2026	Details
CS300 IABP. Software Version CS300 IABP C.01. The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.	FDA Z-1487-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 23, 2026	Details
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.	FDA Z-1476-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 20, 2026	Details
Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A There is the potential for the length of the trocar shaft to be too long.	FDA Z-1485-2026	Medical Device	High	Mar 11, 2026 Recall: Jan 15, 2026	Details
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.	FDA Z-1483-2026	Medical Device	High	Mar 11, 2026 Recall: Feb 2, 2026	Details
Brand Name: Hitachi Proton Beam Therapy REF: PROBEAT-CR Software anomaly in the patient positioning system may result in positional discrepancy.	FDA Z-1430-2026	Medical Device	High	Mar 4, 2026 Recall: Feb 6, 2026	Details
Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR Software anomaly in the patient positioning system may result in positional discrepancy.	FDA Z-1429-2026	Medical Device	High	Mar 4, 2026 Recall: Feb 6, 2026	Details
Brand Name: Prodisc Product Name: Prodisc C SK Model/Catalog Number: PDSL6 Software Version: N/A Product Description: Total cervical disc replacement Component: No Products were mislabeled as the 6mm product but included the 5 mm product.	FDA Z-1426-2026	Medical Device	High	Feb 25, 2026 Recall: Dec 31, 2025	Details
Da Vinci 5 ASSY, DV5 CONSOLE, IS5000 Model/Catalog Number: 380730 Used for minimally invasive surgery. An error event following the release of a software version for the surgical system that can result in loss of user interface content on an external monitor or tower monitor.	FDA Z-1428-2026	Medical Device	High	Feb 25, 2026 Recall: Nov 17, 2025	Details
Olympus High Flow Insufflation Unit. Model Number: UHI. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. Issue with software algorithm which may lead to overpressure events.	FDA Z-1352-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 16, 2026	Details
Brand Name: Spectrum IQ Product Name: Infusion Pump Model/Catalog Number: 3570009 Software Version: N/A Product Description: Infusion Pump, one unit per carton Component: N/A Pumps were released without full testing being performed, including occlusion alarm testing.	FDA Z-1368-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 13, 2026	Details
Olympus High Flow Insufflation Unit. Model/ Number: UHI-2. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. Issue with software algorithm which may lead to overpressure events.	FDA Z-1353-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 16, 2026	Details
Olympus High Flow Insufflation Unit. Model Number: UHI-3. Used for insufflation of the abdominal cavity, and automatic suction and smoke evacuation to facilitate laparoscopic observation and treatment within the abdominal cavity. Issue with software algorithm which may lead to overpressure events.	FDA Z-1354-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 16, 2026	Details
MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with software Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.	FDA Z-1383-2026	Medical Device	High	Feb 25, 2026 Recall: Jan 21, 2026	Details
Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.	FDA Z-1351-2026	Medical Device	High	Feb 18, 2026 Recall: Jan 26, 2026	Details

Showing 101 - 125 of 210 product recalls

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Medical Device Recalls Today

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How To Check Medical Device Recalls: FDA Device Safety Alerts And Recall Notices

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