Shelhigh, Inc. implantable medical devices.

Government Resource

Shelhigh, Inc. implantable medical devices.

May 2, 2007

Food and Drug Administration; FDA

This announcement alerts health care providers and consumers to potential contamination of medical devices from one manufacturer.

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FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering.

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January 25, 2017

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FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death.

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Reprocessing of Reusable Medical Devices.

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March 8, 2023

The incidence of opioid misuse among the surgical patients with persistent opioid use.

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Use of recalled devices in new device authorizations under the US Food and Drug Administration's 510(k) pathway and risk of subsequent recalls.

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December 21, 2022

Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up.

October 19, 2022

Maternal Health Research Centers of Excellence (U54 Clinical Trial Optional).

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Use duodenoscopes with innovative designs to enhance safety: FDA Safety Communication.

May 4, 2022

HEAR Her Concerns.

April 6, 2022

COVID-19 Focused Inspection Initiative in Healthcare.

March 23, 2022

Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication.

October 20, 2021

Letter to Health Care Providers: Safe Use of Surgical Staplers and Staples.

October 7, 2021

Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11.

September 1, 2021

Use purple bracelets or wristbands only for do not resuscitate status - letter to industry.

August 25, 2021

FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy.

August 20, 2021

Accidental exposures to fentanyl patches continue to be deadly to children.

July 21, 2021

FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing.

February 24, 2022 - February 24, 2022

Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling.

May 19, 2021

Hospital Compare.

May 13, 2021

Using ventilator splitters during the COVID-19 pandemic--letter to health care providers.

February 17, 2021

Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings.

February 17, 2021

Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling.

February 10, 2021

FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only.

February 3, 2021

Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products.

January 13, 2021

Wear face masks with no metal during MRI exams.

December 16, 2020

Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers.

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