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Showing 6821–6840 of 8389 results

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Tray Ring Cover (Johnson & Johnson) – Sterility Breach (2022)

Potential breach in the sterility barrier for tray ring covers.

FDAApr 6, 2022Nationwide• Johnson & Johnson Surgical Vision Inc

Accula SARS-CoV-2 Test (Mesa Biotech) – False Positive Risk (2022)

SARS-CoV-2 Test has an increased potential for false positive results, which may lead to a delay in correct diagnosis and treatment.

FDAApr 6, 2022Nationwide• MESA BIOTECH, INC

V8 Immunodisplacement Kit (Helena) – Microbial Growth (2022)

Due to microbial growth causing interference with interpretation.

FDAApr 6, 2022FL, MO, OH +1 more• Helena Laboratories, Corp.

Verigene Processor SP (Luminex) – Temperature Limit Issue (2022)

Heater within the Verigene System may be outside of established temperature limits for assays which could result in false negative results.

FDAApr 5, 2022AZ, CA, CO +13 more• Luminex Corporation

Medi-First XS Kit (Certified Safety) – Component Deviation (2022)

First aid kit and cabinet components are being recalled by the supplier due to cGMP deviations at the manufacturer.

FDAApr 5, 2022AL, AZ, CA +33 more• Certified Safety Mfg Inc

SARS-CoV-2 Antigen Test (USA Medical) – Unauthorized Distribution (2022)

COVID-19/SARS-CoV-2 Antigen Tests did not receive FDA Emergency Use Authorization, nor were the tests cleared or approved to be commercially distributed.

FDAApr 4, 2022Nationwide• USA Medical, LLC

Karl Storz Cysto-Urethroscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

VitriGuard (CooperSurgical) – Sterility Barrier Risk (2022)

Products in this lot may have compromised barrier seals, introducing a risk to sterility.

FDAApr 1, 2022AZ, CA, FL +7 more• CooperSurgical, Inc.

Karl Storz Nasopharyngolaryngoscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022Nationwide• Karl Storz Endoscopy

Karl Storz Video Cysto-Urethroscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

11272VN Flexible Video Urethro Cystoscope (Karl Storz) – disinfection failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Flo-Thru Intraluminal Shunt (Baxter) – Foreign Matter Potential (2022)

There is a potential for foreign matter.

FDAApr 1, 2022Nationwide• Baxter Healthcare Corporation

Getinge 9100-Series Washer (Getinge) – Installation Verification (2022)

Laceration Risk

Inadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to installation failure modes and hazardous situations.

FDAApr 1, 2022AZ, CA, CO +31 more• Getinge Usa Sales Inc

Karl Storz Ureteroscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Turbett Surgical Container (Turbett) – Weld Failure (2022)

Eight units manufactured before June 2019 have exhibited weld failures breaching the sterile barrier after prolonged use.

FDAApr 1, 2022CA, NY, PA• TURBETT SURGICAL, LLC

11274BCU1 Flexible Cystoscope (Karl Storz) – disinfection failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Karl Storz HD Cysto-Urethroscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Karl Storz Uretero-Renoscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Karl Storz Cysto-Urethro-Fiberscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

Karl Storz Ureteroscope (Karl Storz) – Disinfection Failure (2022)

Failure to achieve the expected six-log reduction in microorganisms following the disinfection process.

FDAApr 1, 2022AL, AK, AZ +48 more• Karl Storz Endoscopy

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