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Showing 3141–3160 of 11714 results

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8MM Round Tip Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Large Hem-O-Lok Clip Applier (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

VITROS XT 7600 System (Ortho-Clinical) – Reagent Pack Notification Issue (2024)

The VITROS XT 7600 Integrated System software versions 3.8.0 may not correctly notify users if the Signal Reagent Pack exceeds the on-board and/or shelf-life expiration date. This could result in the use of expired products, which would increase the risk of no results or erroneous results from the instrument.

FDADec 19, 2024Nationwide• Ortho-Clinical Diagnostics, INc.

Bodor P and C Series Laser Machines (Jinan Bodor) – Non-Compliant Lasers (2024)

Non-compliant laser products

FDADec 19, 2024Nationwide• Jinan Bodor Cnc Machine Co Ltd NO.1299, XINLUO AVE HI-TECH ZONE Jinan China

8MM Monopolar Curved Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Horizon Small Clip Applier (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Potts Scissors (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Resano Forceps (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Large SutureCut Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Atrial Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Tip-Up Fenestrated Grasper (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Mega Needle Driver (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Force Bipolar (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Curved Bipolar Dissector (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

8MM Small Grasping Retractor (Intuitive Surgical) – Grip Cable Failure (2024)

Due to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws.

FDADec 19, 2024AL, AK, AZ +49 more• Intuitive Surgical, Inc.

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Pediatric Uretero-Renoscope (Karl Storz) – Reprocessing Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

KARL STORZ Uretero-Renoscope (Karl Storz) – Reprocessing Modality Issue (2024)

Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA.

FDADec 19, 2024Nationwide• Karl Storz Endoscopy

Methadone Tablets 5mg (West-Ward) – illegible identification (2024)

Failed Tablet/Capsule Specifications: Illegible product identification for the unit dose configuration only.

FDADec 19, 2024Nationwide• West-Ward Columbus Inc

EMPOWR 3D Knee Tibial Insert (Unknown) – Incorrect Sizing Risk (2024)

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.

FDADec 18, 2024Nationwide

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