Recalls affecting Alaska
Notices that name Alaska in their distribution area, plus every nationwide recall — nationwide recalls reach Alaska too.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Intuitive Surgical, Inc. Brand Name: Ion Endoluminal System Product Name: Ion Vision recall: Due to probe bags that may have a compromised or incomplete sterile pouch seal
Due to probe bags that may have a compromised or incomplete sterile pouch seal.
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Class II · 9 months ago
Beckman Coulter Ireland, Inc. The LDL-Cholesterol assay is comprised of two distinct recall: Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting
Beckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL…
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Class II · 9 months ago
Mazor X robotic guidance system REF: TPL0059 recall: Software errors that can result in incorrect surgical instrument positioning
Software errors that can result in incorrect surgical instrument positioning during spinal surgery.
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Class II · 9 months ago
Tyber Medical Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column recall: The supplier manufactured anatomical left plates with an incorrect thread
The supplier manufactured anatomical left plates with an incorrect thread orientation.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Patient Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Philips North America Patient Information Center iX recall: A recent software (SW) patch modifies Mobile Event Notification filter
A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the…
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Class II · 9 months ago
Brand Name: EDAN Product Name: Central Monitoring System Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Merit Medical Systems, Inc. Allwell Angioplasty Pack REF: IS-30-B1/B recall: Inflation device handle may detach from the syringe during procedure
Inflation device handle may detach from the syringe during procedure.
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Class II · 9 months ago
Sysmex America, Inc. TS-10/TS-10H Tube Sorter, automatic sorting system for sorting recall: Under specific conditions, the lift's electromagnetic holding force
Under specific conditions, the lift's electromagnetic holding force may disengage unexpectedly, allowing unintended downward movement of the lift.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Vital Signs Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A recall: Inflation device handle may detach from the syringe during procedure
Inflation device handle may detach from the syringe during procedure.
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Class II · 9 months ago
ICU Medical Plum Duo Precision IV Pump, List Numbers: 400020403 recall: Plum Solo and Duo Infusion pumps include a feature
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The…
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Class II · 9 months ago
Brand Name: EDAN Product Name: Vital Signs Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B recall: Inflation device handle may detach from the syringe during procedure
Inflation device handle may detach from the syringe during procedure.
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Class II · 9 months ago
Baxter Healthcare Corporation SIGMA Spectrum Infusion Pump, Model/ recall: Certain pumps have potentially been released from service with defective
Certain pumps have potentially been released from service with defective grease applied to the cam and motor gears. Due to its low viscosity, the…
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Class II · 9 months ago
Brand Name: Leaseir Product Name: Leaseir MHR Xcell Model/ recall: The console label for affected devices is missing the "DANGER" symbol
The console label for affected devices is missing the "DANGER" symbol.
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Class II · 9 months ago
Brand Name: EDAN Product Name: Vital Signs Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Brand Name: EDAN Product Name: Patient Monitor Model/ recall: As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm…
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Class II · 9 months ago
Community Products, LLC Rifton Equipment, E-Pacer. Model/ recall: Potential for fraying on the body support strap
Potential for fraying on the body support strap.
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Class II · 9 months ago
Tyber Medical Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column recall: The supplier manufactured anatomical left plates with an incorrect thread
The supplier manufactured anatomical left plates with an incorrect thread orientation.
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Class II · 9 months ago
Merit Medical , Custom Waste Management Kit Vascular Tray REF recall: Inflation device handle may detach from the syringe during procedure
Inflation device handle may detach from the syringe during procedure.
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Class II · 9 months ago
Merit Medical , Custom Manifold Kit REF: K09-13203A recall: Inflation device handle may detach from the syringe during procedure
Inflation device handle may detach from the syringe during procedure.
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Class II · 9 months ago
Community Products, LLC Rifton Equipment, TRAM. Model/ recall: Potential for fraying on the body support strap
Potential for fraying on the body support strap.