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Showing 6221–6240 of 11714 results

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Modular Cooler-Heater (CardioQuip) – bacterial contamination (2023)

There is the potential that cooler-heater devices may contain bacterial contamination which could result in patient infection.

FDAOct 24, 2023CA, NE, OH +3 more• CardioQuip, LLC

G-CAM (Graphenano Dental) – machining error (2023)

Machining error on cams renders the device unusable.

FDAOct 24, 2023Nationwide• GRAPHENANO DENTAL SL Calle De Pau Casals

Injection Needle LUER-lock (Karl Storz) – cleaning process risk (2023)

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

High

FDAOct 24, 2023AK, AR, CA +35 more• Karl Storz Endoscopy

Injection Needle 3 Fr. (Karl Storz) – cleaning process risk (2023)

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

FDAOct 24, 2023AK, AR, CA +35 more• Karl Storz Endoscopy

Injection Needle 70 Degrees (Karl Storz) – cleaning process risk (2023)

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

FDAOct 24, 2023AK, AR, CA +35 more• Karl Storz Endoscopy

Injection Needle (Karl Storz) – cleaning process risk (2023)

The efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery, which if used, may expose the patient to a higher risk of infection.

FDAOct 24, 2023AK, AR, CA +35 more• Karl Storz Endoscopy

Intera 1.5T Power/Pulsar (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Ingenia 1.5T CX (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

SmartPath dStream 1.5T (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Achieva 1.5T (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Achieva 1.5T Initial System (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Sage PrimaFit Urine Management (Sage) – undeclared latex (2023)

A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label

FDAOct 23, 2023Nationwide• Sage Products Inc 3909 3 Oaks Rd Cary IL 60013-1804

Achieva 1.5T Conversion (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Ranolazine Tablets 500mg (Glenmark) – failed dissolution (2023)

Failed Dissolution Specifications: Out of specification for dissolution.

Class IIModerate

FDAOct 23, 2023Nationwide• Glenmark Pharmaceuticals Inc., USA

Intera 1.5T (Philips) – fire potential (2023)

Potential component failure in the Gradient Coil could product smoke and/or fire.

FDAOct 23, 2023Nationwide• Philips North America Llc

Equate Hand Sanitizer (Omega & Delta) – Potency Issue (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

Oxaydo Tablets (Zyla Life Sciences) – Sub-potent Drug (2023)

Sub-potent Drug: Lower potency than labeled.

FDAOct 20, 2023Nationwide• Zyla Life Sciences US Inc.

DOP Hand Sanitizer Original (Omega & Delta) – Potency Problem (2023)

Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.

Class IIModerate

FDAOct 20, 2023IN, PR• Omega & Delta Co., Inc.

Kuka Flex Forte Caplets (Botanical Be) – Undeclared Ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

Reumo Flex Caplets (Botanical Be) – undeclared ingredient (2023)

Undeclared Allergen

Marketed Without an Approved NDA/ANDA: products found to contain undeclared diclofenac.

FDAOct 20, 2023Nationwide• Botanical Be

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