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Showing 10621–10640 of 35905 results

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BencoDental iris 5% NaF varnish, WHITE MINT ITEM # 4323-6... (Young Dental Manufacturing I, LLC) – the iris 5% fluoride varnish white mi... (2023)

The Iris 5% Fluoride Varnish White Mint package lot 207540 may contain units of 5% Fluoride Varnish Bubblegum.

FDAMay 23, 2023FL, NV, PA• Young Dental Manufacturing I, LLC

PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Siz... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

wDR 2.2 Mobile Digital Diagnostic X-Ray System (SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain) – there is a software login in issue th... (2023)

There is a software login in issue that may prevent the user from logging in.

Low

FDAMay 23, 2023Nationwide• SEDECAL SA PELAYA, 9 POL. POL. IND. RIO DE JANEIRO Algete Spain

SurgiMend 3.0; Collagen Matrix for Soft Tissue Reconstruc... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

PriMatrix; Dermal Repair Scaffold; Rx Only; Sizes 0.2x26.... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

Revize-X; Collagen Matrix for Soft Tissue Reconstruction;... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

PriMatrix Meshed; Dermal Repair Scaffold; Rx Only; Sizes ... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

PriMatrix Fenestrated; Dermal Repair Scaffold; Rx Only; S... (TEI Biosciences, Inc.) – possible out of specification endotox... (2023)

Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

FDAMay 23, 2023Nationwide• TEI Biosciences, Inc.

HealthyWiser KetoFast" Ketone Test Strips REF 900-1K 150... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

HealthyWiser UriTest" 10 Parameter Reagent Test Strips fo... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

2023 NISSAN LEAF – nissan north america, inc (2023)

Nissan North America, Inc. (Nissan) is recalling certain 2023 LEAF vehicles. The right-hand brake tubes may have been damaged during production and could corrode, possibly causing a hole in the brake line and a brake fluid leak.

NHTSAMay 22, 2023Nationwide• NISSAN

Medtronic ILLUMISITE Platform Console, Model Number ILS-1... (Covidien, LLC) – single illumisite platform console wa... (2023)

Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.

FDAMay 22, 2023IN• Covidien, LLC

PrestiBio URINALASYS TEST STRIP 10 PARAMETERS REF 900-10 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

DiagnosUS Pregnancy Test Midstream REF 100-17 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

Hemospray Endoscopic Hemostat: Reference Part Numbers: ... (Wilson-Cook Medical Inc.) – there are potential risks of the hemo... (2023)

There are potential risks of the Hemospray powder adhering to the distal end of the endoscope, which can result in adhesion of the endoscope to tissue and consequent difficulty or inability to maneuver/remove the endoscope.

FDAMay 22, 2023Nationwide• Wilson-Cook Medical Inc.

BD Pyxis CII Safe, Software: V7, REF: 107-96, 107-97, 107... (CareFusion 303, Inc.) – shock hazard (2023)

Automated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which could expose users to system downtime and/or potential electric shock.

FDAMay 22, 2023Nationwide• CareFusion 303, Inc.

2021 POLESTAR POLESTAR 1 – fire hazard (2023)

Polestar Automotive USA, Inc. (Polestar) is recalling certain 2020-2021 Polestar 1 vehicles. Defective high-voltage battery cells may cause the battery to overheat when fully charged.

NHTSAMay 22, 2023Nationwide• POLESTAR

Lem Fertility LH Ovulation Test (Strip) REF 200-07 (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

PrestiBio Ovulation Strips REF 200-4 60 LH Test Strips (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

To Life hCG Pregnancy Urine Test Strips Format REF Cat No... (Universal Meditech Inc.) – universal meditech inc (2023)

Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFast" Ketone Test Strips and PrestiBio" Ketone Test Strips without marketing authorization. UMI is also recall their tests because they are going out of business and would not be able to continue fulfilling any post-market responsibilities of these distributed products. UMI claims to hold 510(k)s for the other devices, purchased the intellectual property in 2015 from the previous 510(k) holder, but FDA has been unable to verify this information. The devices may have unknown performance characteristics because the firm is unable to provide any documentation that the devices were manufactured in conformance with the Quality System regulation, including documentation (e.g., DHF) that the distributed devices had not been modified since original clearance in a way that could impact their safety and effectiveness, documentation of controlled storage temperature/humidity, and post-market surveillance documentation, such as complaints and adverse events.

FDAMay 22, 2023CA, FL, IL +5 more• Universal Meditech Inc.

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