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Showing 9321–9340 of 11714 results

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

There is a potential for foreign matter.

FDAApr 1, 2022Nationwide• Baxter Healthcare Corporation

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

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

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 Bronchoscope (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 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

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

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

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

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

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 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

CBD Metered Dose Inhaler (Wellness BioSciences) – Unapproved Drug (2022)

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAApr 1, 2022Nationwide• Wellness BioSciences

Cooper Surgical H/S Elliptosphere Cath (CooperSurgical) – assembly failure (2022)

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

FDAMar 31, 2022Nationwide• CooperSurgical, Inc.

CooperSurgical H/S Catheter Set (CooperSurgical) – assembly failure (2022)

Incorrect bonding material used for assembly of the catheter, may fail, resulting in detachment of component parts, broken components, or leakage. This breakage may result in delay of procedure

FDAMar 31, 2022Nationwide• CooperSurgical, Inc.

Percept PC BrainSense Neurostimulator (Medtronic) – communication failure (2022)

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

FDAMar 30, 2022Nationwide• Medtronic Neuromodulation

HeartWare Manual (Medtronic) – documentation errors (2022)

Errors and inconsistencies that were identified in the Instruction for Use (IFU), Emergency Responder Guide (ERG), and Patient Manual (PM) for the HeartWare Ventricular Assist Device (HVAD) system.

FDAMar 30, 2022Nationwide• Medtronic Inc

Triathlon Tibial Component (Howmedica) – size mismatch (2022)

Stryker has discovered a potential product mix where the size of the Triathlon Tritanium Tibial Component inside the package does not match the package labeling.

FDAMar 30, 2022Nationwide• Howmedica Osteonics Corp.

Percept BrainSense Neurostimulator (Medtronic) – communication failure (2022)

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

FDAMar 30, 2022Nationwide• Medtronic Neuromodulation

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