🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Apr 1, 2022 Other Medical Devices Nationwide
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American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Mar 22, 2022 Other Medical Devices Nationwide
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Shanghai United Imaging Healthcare Co.
🏥 Medical Devices Class I - Dangerous
X-ray imaging system positioning image and protocol label is reversed for Flexion and Extension on C-Spine and L-Spine, this will cause the image to be incorrectly labeled and may cause the patient to have a repeat exposure.
Jul 30, 2019 Diagnostic Equipment Nationwide
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American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Mar 22, 2022 Implants & Prosthetics Nationwide
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🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Apr 1, 2022 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Apr 1, 2022 Other Medical Devices Nationwide
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🏥 Medical Devices Class I - Dangerous
Patient chart label contains incorrect Part Number and volume amount.
Apr 14, 2022 Surgical Instruments Nationwide
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🏥 Medical Devices Class I - Dangerous
Kits were packed into shipping boxes incorrectly.
Mar 21, 2022 Other Medical Devices
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🏥 Medical Devices Class I - Dangerous
SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.
Apr 6, 2022 Diagnostic Equipment Nationwide
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🏥 Medical Devices Class I - Dangerous
Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.
Apr 1, 2022 Other Medical Devices Nationwide
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Daavlin Distributing Company
🏥 Medical Devices Class I - Dangerous
Software issue, resuming an interrupted treatment will result in swap of utilized calibration treatment distance 0" inches to "9. Resulting in over or under dosing.
Apr 26, 2022 Other Medical Devices Nationwide
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American Contract Systems
🏥 Medical Devices Class I - Dangerous
Product was sterilized with a higher than specification EO concentration.
Mar 22, 2022 Other Medical Devices Nationwide
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Yamaha Motor Manufacturing Corp of America, of Newnan, Georgia
🏠 Consumer Products Class I - Dangerous
The recalled vehicles can have a damaged fuel tank causing fuel to leak, posing fire and explosion hazards.
May 12, 2022 Other Consumer Products Nationwide
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Other Foods
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Other Foods
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🍎 Food Class I - Dangerous
Possible Listeria monocytogenes in product
Apr 19, 2022 Other Foods
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Produce
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Other Foods
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Other Foods
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🍎 Food Class I - Dangerous
Macarons do not declare the following colors: FD&C Blue #1, Blue #2, Red #3, Yellow #5, Yellow #6, Red #40.
Mar 23, 2022 Other Foods
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