Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
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Medical devices recalls
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Medline convenience kits containing 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 the brush. Potential…
Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Achieva 3.0T; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
Automated Impella Controller (AIC) with the below product descriptions and corresponding Product Codes. 1
Retrospective report of issues remedied in 2019 with firmware and software patches: 1. Defects in optical bench (OPB) firmware V2.19, which affected the accuracy and sta…
INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set
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 of CPAP pressure, po…
Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
CombiSet Hemodialysis Blood Tubing Set with Attached Priming Set and Transducer Protectors
Communication to recommend reviewing the IFU and ensuring that all treatment preparation and handling steps are performed as instructed.
Ingenia Elition S and Ingenia Elition X; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US, CAT 8100E1-US, CAT 8100EP1, CAT 8100EP1-S…
Complaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure delay.
Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
VITEK 2 AST-N461 TEST KIT, GRAM NEGATIVE SUSCEPTIBILITY TESTING
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 timeframe, causing a…
MR 7700 and Upgrade to MR 7700; Model Number (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
MR 5300 Model Number (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
Cardioroot Woven Collagen Coated Vascular Graft
Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP).
Olympus BiCOAG Hemostasis Probe 10Fr Coaxial Connector
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Ingenia 1.5T, Ingenia 1.5T CX and Ingenia 1.5T S; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm
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,
Medline Convenience Kits
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks t…
Heidelberg Engineering GmbH Product Name
Wheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip over as a result. Fall…
REF: HF2POSTD HomeFill Oxygen System HomeFill cylinder D with CGA870 Compatible Post Valve
Labeling; Oxygen Cylinders do not contain required medical gas labeling
New York Embroidery Studio Trinity Non-Surgical Isolation Gown
Gowns do not consistently meet the minimum liquid-barrier performance required.
Halyard IV START KIT NON-STERILE; 48 kits per case
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may be contaminated with Aspergillus penicillioides.
REF: 81-030415 Myocardial Probe Non-Pyrogenic , 400 Series
Myocardial temperature probes contain an incorrect needle. Specifically, an 18mm needle was included instead of a 15mm needle.
Achieva XR; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
PRO+ 40" MRS SURFACE, mattress with Advanced Microclimate Technology (AMT) uses a non-powered system of intak…
There is an error in the product description on the Unique Device Identification (UDI) label. These discrepancies in labeling do not align with the approved product or p…
Halyard IV START KIT NON-STERILE; 48 kits per case
Convenience kits containing BD ChloraPrep Clear - 1 mL Applicator, which may exhibit an open or incomplete seal on the packaging of the applicator.
Olympus BiCOAG Hemostasis Probe 7Fr Coaxial Connector
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Presource Convenience Kits
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in…
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5;…
Tip may fracture or detach, leading to device fragments remaining within the patient or migrating through the vasculature. Patient impact may include prolonged procedure…
Pearle Vision 1 day Product Name
A small number of lenses within the affected lot are of the incorrect power.
REF:HF2PC9 HomeFill Oxygen System
Labeling; Oxygen Cylinders do not contain required medical gas labeling
Evolution upgrade 1.5T and Evolution upgrade 3.0T; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers
The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury.
Presource Convenience Kits
The kits contain applicators that may exhibit an open or incomplete seal on the packaging of the applicator. Use of a potentially contaminated applicator could result in…
Ingenia 3.0T and Ingenia 3.0T CX; Model Numbers (REF)
A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements…
Olympus BiCOAG Hemostasis Probe 10Fr Fixed Pin Connector
Potential for detachment of ceramic tip due to manufacturing without the designated amount of adhesive.
Midmark IQvitals Zone
A performance issue may result in inaccurate blood pressure readings when the Linear Deflation Method is used.
Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234
Due to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing inaccurate blood flow veloc…
SeaSpine Mariner Deformity Product Name
The proximal thread depth of the spinal device is out of design specification.
FDA enforcement reports (food, drugs, medical devices), USDA FSIS (meat, poultry and eggs) and the CPSC (consumer products), last 45 days. Class I means the product could cause serious harm. Always confirm lot numbers on the official notice.