Medical devices recalls
Implants, monitors, test kits and hospital equipment corrected or removed from the market.
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Class II · 1+ years ago
B Braun Medical Inc Espocan Combined Spinal and Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
ImaCor Inc. ClariTEE Miniaturized TEE probe recall: Production assembly error resulting in the potential for reversed
Production assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex…
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Class II · 1+ years ago
Applied Medical Technology Inc NutraGlide recall: The nasal feeding tubes, NutraGlide, subject to this recall have distal tips
The nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces.
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Class II · 1+ years ago
CorNeat EverPatch, REF: 1036295, Permanent Tissue-Integrating Surgical recall: Reviewed complaints have identified that conjunctival wound dehiscence
Reviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch.
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray with Perifix 17 recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class I · 1+ years ago
Abiomed, Inc. Automated Impella Controller , used for left heart support blood pump recall: Potential cybersecurity vulnerabilities related to the operating system
Potential cybersecurity vulnerabilities related to the operating system in the Automated Impella Controller (AIC).
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Class II · 1+ years ago
B Braun Medical Inc Combined Spinal and Epidural Anesthesia Tray recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
B Braun Medical Inc Combined Spinal and Epidural Anesthesia Tray 2 recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
GE Medical Systems, SCS AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 recall: Firm has identified a security vulnerability in AW Server products
Firm has identified a security vulnerability in AW Server products. If exploited, a malicious actor could compromise the confidentiality, integrity…
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Class II · 1+ years ago
B Braun Medical Inc Perifix FX Continuous Epidural Anesthesia Tray with Perifix 17 recall: Potential for the lid of the catheter connector to be in the incorrect
Potential for the lid of the catheter connector to be in the incorrect position.
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Class II · 1+ years ago
Canon Medical System, USA, INC. This device is a digital radiography/fluoroscopy recall: It has been found that when SPOT Fluoro is first turned
It has been found that when SPOT Fluoro is first turned on, the default ROI is selected and the collimator blades move to the boundary of the ROI…
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Class I · 1+ years ago
CareFusion 303, Inc. BD Alaris Pump Infusion Sets for the following reference numbers recall: Infusion pump module used with compatible pump infusion sets may perform
Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy…
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Class I · 1+ years ago
NOxBOXi Nitric Oxide Delivery System recall: Fluctuations may be more likely to occur if the total flow through the device
Fluctuations may be more likely to occur if the total flow through the device sensor (used by the device to determine flow) is less than the minimum…
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Class II · 1+ years ago
Northeast Scientific Inc. NES Reprocessed 1.7mm OTW Turbo Elite Laser Atherectomy recall: Potential for breaches in the sterile barrier packaging
Potential for breaches in the sterile barrier packaging, compromising sterility assurance.
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Magnetom Verio Dot recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class II · 1+ years ago
Aesculap Elan 4 Fixed Duraguard Long recall: Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long"
Mislabeling. The ELAN 4 FIXED DURAGUARD STANDARD was labeled as "Long" and the ELAN 4 FIXED DURAGUARD LONG was labeled as "Standard."
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Class II · 1+ years ago
W L Gore & Associates, Inc. Gore Acuseal Vascular Graft, REF: ECH050020J, ECH050020W recall: Reports of vascular graft delamination, which may lead to reduced access
Reports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to…
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Biograph One recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class I · 1+ years ago
Medline Industries, LP Reprocessed ViewFlex Xtra ICE Catheter to visualize cardiac recall: Specific lots of reprocessed electrophysiology and ultrasound catheters
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual…
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Magnetom Prisma recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class II · 1+ years ago
Bard Peripheral Vascular Inc Venclose digiRF Generators, Model Vcrfg1 recall: Software version 3.35 of the Venclose digiRF Generator incorporates
Software version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring…
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Class I · 1+ years ago
Siemens Medical Solutions USA, Inc Magnetom Connectom.X recall: There is a potential for an ice blockage to form or currently exist within
There is a potential for an ice blockage to form or currently exist within the magnet venting system. In the event of a quench, helium gas may be…
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Class I · 1+ years ago
Medline Industries, LP Reprocessed Acuson AcuNav Ultrasound Catheter for intracardiac recall: Specific lots of reprocessed electrophysiology and ultrasound catheters
Specific lots of reprocessed electrophysiology and ultrasound catheters may contain small residual particulates. If devices with residual…
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Class II · 1+ years ago
Philips Medical Systems Nederland B.v. Allura Xper FD10/10 recall: The BIOS battery may deplete faster than initially anticipated during
The BIOS battery may deplete faster than initially anticipated during the design phase. When the battery is depleted, the start-up process of the…