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Showing 14481–14500 of 35905 results

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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

Mercedes-Benz S 500 (Mercedes-Benz) – steering column issue (2022)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2021 S580 4Matic and S500 4Matic vehicles. The electrical connector to the steering column module may not be secured properly, which can disable gear shifts and/or safety features including the electronic stability program, the driver's air bag, and turn signal indicators.

NHTSAApr 1, 2022Nationwide• MERCEDES-BENZ

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

Autocar Xpeditor (Autocar) – brake system wiring (2022)

Autocar LLC (Autocar) is recalling certain 2021-2022 Xpeditor ACX vehicles. The Anti-Lock Brake System (ABS) modulation valve may be wired incorrectly.

NHTSAApr 1, 2022Nationwide• AUTOCAR

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

Marketed Without an Approved NDA/ANDA

Class IIModerate

FDAApr 1, 2022Nationwide• Wellness BioSciences

Mercedes-Maybach S 580 (Mercedes-Maybach) – seat trim issue (2022)

Mercedes-Benz USA, LLC (MBUSA) is recalling certain 2021-2022 Maybach S580 vehicles. Trim parts on both front seats may detach during rear air bag deployment, which can damage the air bag cushion or cause the air bag to deploy improperly.

NHTSAApr 1, 2022Nationwide• MERCEDES-MAYBACH

Piaggio MP3 500 (Piaggio) – brake hose contamination (2022)

Piaggio Group Americas, Inc. (Piaggio) is recalling certain 2020-2021 MP3 500 HPE scooters. The brake hose terminal fittings zinc plating may contaminate the brake fluid, decreasing brake performance.

NHTSAApr 1, 2022Nationwide• PIAGGIO

Keystone Alpine (Keystone) – power inlet issue (2022)

Keystone RV Company (Keystone) is recalling certain 2022 Alpine, Impact, Arcadia, Avalanche, Fuzion, and Passport travel trailers, equipped with a 50-amp shore power inlet. The power inlet lug bolts may have been manufactured with excessively hard metal, preventing them from being tightened properly and resulting in a loose wiring connection.

NHTSAMar 31, 2022Nationwide• KEYSTONE

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.

Terex XT Pro (Terex) – pivot point lubrication (2022)

Terex South Dakota, Inc. (Terex) is recalling certain 2020-2022 XT Pro aerial devices. The pivot points may not have been lubricated during assembly, which can cause the pins to seize and break the pin retainers.

NHTSAMar 31, 2022Nationwide• TEREX

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