Latest recalls — page 15
Older notices, newest first.
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Class I · 26 days ago
Boston Scientific Corporation Imager II Angiographic Catheters M001314001 Imager recall: Tip may fracture or detach, leading to device fragments remaining within
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include…
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Class II · 26 days ago
Cardinal Health 200, LLC Presource Convenience Kits: 1) KIT, PRE OP recall: The kits contain applicators that may exhibit an open or incomplete seal
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated…
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Class II · 26 days ago
Olympus BiCOAG Hemostasis Probe 7Fr 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
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 exhibit an open or incomplete seal on the packaging of the applicator.
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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
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm recall: Potential for the inflation chart label affixed to the shaft of the device
Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,
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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
Biomerieux Inc Vitek 2 Ast-N461 Test KIT, Gram Negative Susceptibility Testing recall: The issue is related to card pouch damage associated with a portion
The issue is related to card pouch damage associated with a portion of the lot which was produced on a specific card pouching device, in a specific…
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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.