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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

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.

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

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

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

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

Invacare TDX SP2 (Invacare) – battery wiring disconnect (2022)

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

HeartWare VAD System (Heartware) – translation errors (2022)

Vanta INS Neurostimulator (Medtronic) – communication problem (2022)

Dragonfly OpStar Imaging Catheter (Abbott) – marker separation (2022)

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

HeartWare Manual (Medtronic) – documentation errors (2022)

VITEK 2 Systems (bioMerieux) – software reporting issue (2022)

Smart Toe II Implant (Stryker) – label coverage (2022)

VITROS FSH Reagent Pack (Ortho-Clinical) – result imprecision (2022)

Puritan Bennett 980 Ventilator (Medtronic) – alarm malfunction (2022)

BD Anti-Kappa APC (BD Biosciences) – flow profile issue (2022)

K-Wire (Arthrex) – dimension specification (2022)

Olympus Uretero-reno Videoscope (Olympus) – bending section crack (2022)

BD Anti-Kappa PE (BD Biosciences) – flow profile issue (2022)

STRATAFIX Spiral Suture (Ethicon) – component mix-up (2022)