Gurnee, IL, Akorn Operating Company LLC has filed Chapter 7 bankruptcy on February 23, 2023. In connection with that filing, the company has ceased and shutdown all operations and terminated all its employees of all domestic US Sites. The Akorn Trustee is initiating a voluntary recall of various w

2023 Medical Device Recalls

A cracked manifold on some BALLARD ACCESS Closed Suction Systems may cause inadequate ventilation or other injury to vulnerable patients.

Fluid leaking into the Ivenix Infusion System may prevent the pump from delivering fluid or stop working before therapy is finished.

FDA is requiring several updates to the prescribing information for both immediate-release (IR) and extended release/long acting (ER/LA) opioid pain medicines. The FDA is adding a new warning about opioid-induced hyperalgesia.

Find answers to frequently asked questions on Philips Respironics ventilators, BiPAP, and CPAP machines recall

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices.

Certain surgical respirators, surgical masks, and pediatric face masks by O&M Halyard do not meet quality and performance expectations.

Certain Philips Respironics DreamStation CPAP and BiPAP Machines are recalled because they may not deliver the right correct amount of breathing support.

The readers that are part of FreeStyle Libre Glucose Monitoring Systems may grow extremely hot or catch on fire, posing significant risk to users.

Abbott initiated a voluntary medical device correction in February to emphasize instructions for its FreeStyle Libre®, FreeStyle Libre® 14 day and FreeStyle Libre® 2 Readers in the United States due to a limited number of reports worldwide (0.0017%) from users over several years that their reader’s

Camber Pharmaceuticals, Inc. is voluntarily recalling lot # E220182 of Atovaquone Oral Suspension, USP 750mg/5mL to the Consumer/User level, due to the potential Bacillus cereus contamination in the product. : In the population most at risk, immunocompromised population, there is a reasonable proba

Communication loss between Executive Processor and Video Generator PCBAs may cause unexpected shutdown, interrupting therapy to the patient with no warning.

Certain dental devices have not been cleared or approved by the FDA.

Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the

Canton, SD, Jarman’s Midwest Cleaning Systems, Inc. is voluntarily recalling all lots of Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-sterile Solution and Isopropyl Alcohol Antiseptic 75% Topical Solution Hand Sanitizer Non-sterile Solution to the consumer level. FDA testing found the

Many Exactech knee, ankle, and hip replacement devices were packaged in defective bags and may fail.

La FDA actualiza la información sobre los reportes de carcinoma de células escamosas en la cápsula alrededor de los implantes de seno.

Parsippany. New Jersey. Ascend Laboratories LLC. is voluntarily recalling Dabigatran Etcxilate Capsules. USP 75 mg and 150 mg to the consumer/user level due to the presence of a nitrosamine. N-nitroso-dabigatran, above the established Acceptable Daily Intake (ADI) level. To date, Ascend Laboratorie

The coiled cord on some Cardiosave IABPs may fail and cause an unexpected shutdown, interrupting therapy to the patient with no warning.