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MedWatch Safety Alert

2021 Medical Device Recalls

List of Medical Device recalls in 2021.


Scentsational Soaps & Candles, Inc. Voluntarily Expands Nationwide Recall of Scented Hand Sanitizers Due to the Presence of Methanol (Wood Alcohol), Benzene and Acetaldehyde

Scentsational Soaps & Candles, Inc., has voluntarily expanded its April 27 recall of scented Hand Sanitizers to include three lots of Goose Creek HAND SANITIZER (NDC 75078-004) + Aloe and one lot of COCO TKO HAND SANITIZER in 3.38 and 3.4 fluid ounce spray bottles, respectively, to the consumer leve


Abbott (formally known as “St. Jude Medical”) Recalls Assurity™ and Endurity™ Pacemakers for Potential Moisture Ingress Causing Electrical Short and Reduced Battery Life

Assurity™ and Endurity™ implantable pacemakers correct bradycardia. Moisture may enter some devices, causing electrical problems and shorter battery life.


Global Sanitizers Issues Voluntary Nationwide Recall of Medically Minded Hand Sanitizer Due to Presence of Undeclared Methanol

Las Vegas, NV, Global Sanitizers is voluntarily recalling 50 thousand units of Medically Minded hand sanitizers, lot numbers: E212020 & E082020 Best Buy of 5/21/2022 to the user/consumer level. FDA analysis has found the product to contain methanol.


Medtronic, Inc. Recalls Instructions for Use and Patient Manual for HeartWare HVAD System to Update Information about Carrying Case, Driveline Cover, and Controller Power-Up Issues

The HeartWare HVAD System is used in patients with heart failure. The Instructions for Use and Patient Manual Will be Updated to Address System Issues.


Dibar Nutricional S. de R.L. De C.V. Issues Voluntary Nationwide Recall of DIBAR Labs Hand Sanitizer Due to the Presence of Methanol (Wood Alcohol)

Morelia, Michoacán, Mexico, Dibar Nutricional S. de R.L. De C.V. (“Dibar”) is voluntarily recalling 27 lots of DIBAR Labs Hand Sanitizer packaged in 8oz (8-53090-00301-3 UPC) and 16 oz (8-53090-00302-0 UPC) fluid ounce bottles, respectively, to the consumer level. (See products listed below in Tabl


Yamtun7 Issues Voluntary Nationwide Recall of Poseidon Platinum 3500 Due to the Presence of Undeclared Tadalafil and Sildenafil

Delray Beach, Florida, Yamtun7 is voluntarily recalling all lots of Poseidon Platinum 3500 to the consumer level. FDA analysis has found the product to contain undeclared tadalafil and sildenafil. Tadalafil and sildenafil are drugs known as phosphodiesterase (PDE-5) inhibitors found in FDA approved


Novo Nordisk Issues Voluntary Nationwide Recall of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy® Product Samples Due to Improper Storage Temperature Conditions

Novo Nordisk is voluntarily recalling 1,468 product samples listed in the table below of Levemir®, Tresiba®, Fiasp®, Novolog® and Xultophy®, to the consumer level. These products are being recalled because they were stored at temperatures below storage requirements. This recall only impacts product


Hospira Issues A Voluntary Nationwide Recall for One Lot of Sterile Water for Injection, USP, Due to the Potential Presence of Visible Particulate

Hospira, Inc., a Pfizer company, is voluntarily recalling lot DN9185 of Sterile Water for Injection, USP, 100 mL Single Dose Glass Fliptop Vial, to the hospital/institution level due to a confirmed customer report for a single vial with a visible particulate.