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Showing 501–520 of 1734 results

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ICU Medical ChemosafeLock Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Vial Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

CellMek SPS System (Beckman Coulter) – Incorrect Volume Listing (2025)

Automated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead volumes: Cassette Type/List volume/correct volume, B/750/1582 microliters, and E/1300/2093 microliters. Device software does not rock Cassette E, used with 15mmX92mm Sarstedt tubes. May lead to incorrect diagnosis or error in patient management/treatment.

Moderate

FDASep 8, 2025Nationwide• Beckman Coulter, Inc.

ICU Medical Graduated Connector (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

ICU Medical ChemoLock Mini Bag Spike (ICU Medical) – Port Weld Leak (2025)

Port weld of drug transfer device may separate or break during use and potentially result in a leak.

FDASep 8, 2025Nationwide• ICU Medical, Inc.

Cyclopen Cyclodialysis System (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

FDASep 6, 2025Nationwide• Iantrek Inc.

C-Rex UNO Goniotomy Instrument (Iantrek) – Packaging Integrity (2025)

Potential for compromised integrity of the sterile packaging.

FDASep 6, 2025Nationwide• Iantrek Inc.

DVI Display (Spacelabs) – EMI Cable Risk (2025)

Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically sensitive medical device are in use.

FDASep 5, 2025Nationwide• Spacelabs Healthcare, Inc.

AW Server (GE Medical Systems) – Security Vulnerability (2025)

Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity, and availability of patient data.

FDASep 5, 2025Nationwide• GE Medical Systems, SCS

FRED Flow Diverter (MicroVention) – Manufacturing Defect (2025)

Flow diverter may have a manufacturing issue related to the tantalum length and/or tantalum attachment pattern, which may lead the device to be incompletely open or not properly apposed to the vessel wall, which may necessitate device recapture and withdrawal of the delivery system and microcatheter together. Insufficient apposition could lead to long-term health consequences.

FDASep 5, 2025Nationwide• MICROVENTION INC.

Carescape Central Station (Wipro GE Healthcare) – System Failure (2025)

GE HealthCare has identified an issue affecting Carescape" Central Station (CSCS) with software version V3.0.5, which can cause the system to enter a continuous reboot cycle. If this occurs, a loss of central monitoring of connected patients could result. This issue occurs only when the number of central stations connected to the network is 118, 119 or 120.

FDASep 5, 2025Nationwide• Wipro GE Healthcare Private Ltd. 122 Part 1 Odyssey And Galileo Bengaluru India

Equinoxe Ergo Reamer (Exactech) – Design Testing Incomplete (2025)

Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.

FDASep 5, 2025SC• Exactech, Inc.

XERF EFFECTOR 60 (Lutronic) – Manufacturing Defects (2025)

Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.

FDASep 4, 2025Nationwide• Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Neuroguard Carotid Stent (Contego Medical) – Embolic Protection Issue (2025)

Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.

FDASep 4, 2025Nationwide• Contego Medical LLC

Medical Convenience Kit (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Basic Biopsy Tray (American Contract Systems) – Sterilization Error (2025)

Identified products were re-gassed (sterilized more than once) after a nonconformance occurred during the initial Ethylene Oxide (EO) gas injection process. These products have not been validated for exposure to multiple sterilization cycles. Therefore, product quality, safety, and effectiveness cannot be confirmed for product that was re-gassed.

FDASep 4, 2025Nationwide• American Contract Systems Inc.

Allura Xper FD20 Biplane OR Table (Philips) – Battery Depletion Risk (2025)

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

Allura Xper FD20/20 OR Table (Philips) – Battery Depletion Risk (2025)

The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the system will be halted, and the system will not start. No user messages are shown before the battery is low on power or depleted.

FDASep 3, 2025Nationwide• PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands

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