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2020 Medical Device Recalls

List of Medical Device recalls in 2020.

Medtronic Recalls HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief Due to Risk of Breaks and Tears During Set Up

These devices are parts of the The HeartWare Ventricular Assist System (HVAD). They attach to the HeartWare HVAD pump which helps the heart deliver blood to the rest of the body. The clamp screws are at risk of breaking when tightening the strain relief clamp and outflow graft tears have been observ

Apotex Corp. Issues Voluntary Nationwide Recall of Metformin Hydrochloride Extended-Release Tablets 500mg Due to the Detection of N-nitrosodimethylamine (NDMA)

Apotex Corp is voluntarily recalling all lots of Metformin Hydrochloride Extended-Release Tablets, USP 500mg within expiry to retail level. Apotex was notified by the U.S. Food and Drug Administration (US FDA) that one lot of Metformin Hydrochloride Extended-Release Tablets, USP was tested and showe

Use the Correct Cycle and Compatible N95 Respirators When Decontaminating Respirators with STERRAD Sterilization Systems - Letter to Health Care Providers

The FDA is reminding reprocessing staff in health care facilities to use the correct decontamination cycle associated with certain models of the ASP STERRAD Sterilization Systems to decontaminate compatible NN95 respirators.

Acella Pharmaceuticals, LLC Issues Voluntary Nationwide Recall of Certain Lots of NP Thyroid® (Thyroid Tablets, USP) Due to Super Potency

Acella Pharmaceuticals, LLC is voluntarily recalling a total of 13 lots of 30-mg, 60-mg and 90-mg NP Thyroid® (thyroid tablets, USP) to the consumer level. The products are being recalled because our testing has found these lots to be superpotent. The product may have up to 115.0% of the labeled amo

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