Recalls affecting Hawaii
Notices that name Hawaii in their distribution area, plus every nationwide recall — nationwide recalls reach Hawaii too.
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Class II · 3 months ago
Pride Mobility Products Corp. Brand Name: Quantum Rehab Product Name: Quantum 4Front recall: If the "Remind Me Later" option is selected for user reminders
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs…
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Class II · 3 months ago
GE Medical Systems Information Technologies Inc GE Healthcare Portrait Core Services recall: A software vulnerability may allow unauthorized persons to gain privileged
A software vulnerability may allow unauthorized persons to gain privileged access to the device, which could result in loss of patient monitoring…
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Class I · 3 months ago
AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic recall: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates…
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Class II · 3 months ago
Stryker Ahto Tube SET Packaging recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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Class II · 3 months ago
Innovasis, Inc Anti-Torque, Vector, Part: LS-749 part of Vector recall: Pedicle screw system intended to provide immobilization/stabilization
Pedicle screw system intended to provide immobilization/stabilization of spinal segments as adjunct to thoracic/lumbar/sacral spine fusion may have…
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Class II · 3 months ago
United Orthopedic Corp. Brand Name: USTAR II Knee System Product Name: Hinge Box recall: Due to an incomplete process of the component screw by a subcontractor
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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Class II · 3 months ago
Stryker Ahto Dual Spike Tube SET Packaging recall: There has been an increased amount in reported complaints consistently
There has been an increased amount in reported complaints consistently describing leaking from the handpiece during use.
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Class II · 3 months ago
Instrumentation Laboratory GEM Premier 5000 PAK Part Numbers: 00055360010 00055360011 recall: The active ingredient concentration in the lysing bag solution of specific
The active ingredient concentration in the lysing bag solution of specific GEM Premier 5000 lots did not meet established manufacturing…
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Class II · 3 months ago
Tissium Sa Brand Name: Coaptium Connect Product Name: Coaptium Connect Model/ recall: Currently labeled shelf life of 36 months is not substantiated by real-time
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26…
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Class II · 3 months ago
Aniara Diagnostica LLC 5-Plasma Bivalirudin AMR Verification Kit recall: Stability issues with the reconstituted lyophilized human plasma
Stability issues with the reconstituted lyophilized human plasma and bivalirudin matrix have been identified. These stability issues lead to a…
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Class II · 3 months ago
Copan WASP Brand Name: Wasplab Product Name: Wasplab Model/ recall: Due to a software issue within the WebApp that potentially prevents the user
Due to a software issue within the WebApp that potentially prevents the user to overwrite the results.
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Class II · 3 months ago
Happiest Baby, Inc Pre-loved SNOO Smart Sleeper Model:S1000 recall: This recall is retroactively being reported. Refurbished bassinets failed
This recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution.
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Class II · 3 months ago
Tissium Sa Brand Name: Coaptium Connect Product Name: Coaptium Connect Model/ recall: Currently labeled shelf life of 36 months is not substantiated by real-time
Currently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26…
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Class II · 3 months ago
Pride Mobility Products Corp. Brand Name: Quantum Rehab Product Name: Quantum Outback recall: If the "Remind Me Later" option is selected for user reminders
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs…
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Class II · 3 months ago
Pride Mobility Products Corp. Brand Name: Quantum Rehab Product Name: Q6 Edge 3 recall: If the "Remind Me Later" option is selected for user reminders
If the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs…
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Class II · 3 months ago
United Orthopedic Corp. Brand Name: U2 Total Knee System Product Name: PSA Box Trial recall: Due to an incomplete process of the component screw by a subcontractor
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
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Class II · 3 months ago
Boston Scientific Corporation Radial Jaw 4 Jumbo Biopsy Forceps with the following recall: Potential for breach in sterile barrier of device packaging
Potential for breach in sterile barrier of device packaging.
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Class I · 3 months ago
AVID Medical, Inc. Halyard convenience kits containing recalled Medline Namic recall: Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds
Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates…
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Class II · 3 months ago
United Orthopedic Corp. Brand Name: U2 Total Knee System Product Name: Femoral offset recall: Due to a design issue causing the incorrect engraved numbering on implant
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
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Class II · 3 months ago
Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis recall: Incorrect labeling- The labeled box for the Large Esophageal Flange contains
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the…
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Class II · 3 months ago
Freudenberg Medical, LLC Blom-Singer Classic Indwelling Voice Prosthesis recall: Incorrect labeling- The labeled box for the Large Esophageal Flange contains
Incorrect labeling- The labeled box for the Large Esophageal Flange contains a Large Esophageal and Tracheal Flange, and the labeled box for the…
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Class II · 3 months ago
Beckman Coulter Inc. REF # D23354, MicroScan LabPro V5.03 Panel Update 11 DVD Kit recall: Analyzers contain incorrect algorithms which may affect antimicrobial
Analyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications."
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Class II · 3 months ago
GE Medical Systems Information Technologies Inc GE Healthcare MAC VU360, REF# recall: Software issue issue with the MAC VU360 v3.0 system. After selecting
Software issue issue with the MAC VU360 v3.0 system. After selecting the order refresh icon, an open preview or review screen might fail to close…
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Class II · 3 months ago
Integrated Medcraft LLC Forward Oral Airway Kit . REF Number: 1011-40002. Containing recall: Devices could potentially contain an occluded or partially occluded Guedel
Devices could potentially contain an occluded or partially occluded Guedel Airway tip.