Recalls affecting Arizona
Notices that name Arizona in their distribution area, plus every nationwide recall — nationwide recalls reach Arizona too.
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Class II · 26 days ago
Baxter Healthcare Corporation PRO+ 40" MRS Surface recall: There is an error in the product description on the Unique Device
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the…
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Class II · 26 days ago
Philips North America Llc Achieva XR recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
DeRoyal Industries Inc REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series recall: Myocardial temperature probes contain an incorrect needle. Specifically
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
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Class I · 26 days ago
AVID Medical, Inc. Halyard IV Start KIT Non-Sterile recall: Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
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Class II · 26 days ago
New York Embroidery Studio Trinity Non-Surgical Isolation Gown recall: Gowns do not consistently meet the minimum liquid-barrier performance required
Gowns do not consistently meet the minimum liquid-barrier performance required.
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Class II · 26 days ago
Ventec Life Systems, Inc. REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D recall: Labeling; Oxygen Cylinders do not contain required medical gas labeling
Labeling; Oxygen Cylinders do not contain required medical gas labeling
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Class II · 26 days ago
Brand Name: Heidelberg Engineering GmbH Product Name: Spectralis recall: Wheels may come loose when module is being pushed or pulled during movement
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip…
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Class II · 26 days ago
Medline Convenience Kits: 1) Anterior Spine Pack recall: The kits contain neurological sponges with the potential for unexpected
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may…
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Class II · 26 days ago
Philips North America Llc Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector. Model/ recall: Potential for detachment of ceramic tip due to manufacturing without
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
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Class II · 26 days ago
Intervascular, Sas Cardioroot Woven Collagen Coated Vascular Graft recall: Product failed to meet the specified acceptance criteria for Integral Water
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
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Class II · 26 days ago
Philips North America Llc MR 5300 recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Philips North America Llc MR 7700 and Upgrade to MR 7700 recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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Class II · 26 days ago
Criticare Technologies, Inc. nGenuity Patient Monitor with Capnography CAT recall: Complaint trend where "Checkline Error" alarm presents at device setup
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure…
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Class II · 26 days ago
Philips North America Llc Ingenia Elition S and Ingenia Elition X recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Fresenius Medical Care Renal Therapies Group, LLC CombiSet Hemodialysis Blood Tubing recall: Communication to recommend reviewing the IFU and ensuring that all treatment
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
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Class II · 26 days ago
Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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Class I · 26 days ago
CooperSurgical, Inc. Inca Neonatal Nasal Cpap, Replacement Set. Stay-Flex tubing recall: Potential to exhibit a loose connection between the flexible tubing
Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss…
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Class II · 26 days ago
Abiomed, Inc. Automated Impella Controller with the below product descriptions recall: Retrospective report of issues remedied in 2019 with firmware and software
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected…
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Class II · 26 days ago
Philips North America Llc Achieva 3.0T recall: A software issue will terminate an examination during the image
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that…
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Class II · 26 days ago
Midmark IQvitals Zone, automatically and noninvasively measures recall: A performance issue may result in inaccurate blood pressure readings
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
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Class II · 26 days ago
Medline convenience kits containing Healthmark Instrument Channel recall: Kits contain Healthmark Instrument Channel Brushes
Kits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of…
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Class II · 26 days ago
Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/ recall: Potential for detachment of ceramic tip due to manufacturing without
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.