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MedWatch Safety Alert

2021 Medical Device Recalls

List of Medical Device recalls in 2021.


Arrow International Inc Recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device: 7Fr, Due to Risk of Separation

The 7FR PTD Kits are used to remove clots in adult patients who have arterio-venous (AV) fistulas and synthetic dialysis grafts.


August 7, 2019 UPDATE: Treatment of Peripheral Arterial Disease with Paclitaxel-Coated Balloons and Paclitaxel-Eluting Stents Potentially Associated with Increased Mortality

The FDA is providing updated information about a late mortality signal in patients treated for peripheral artery disease (PAD) in the femoropopliteal artery with paclitaxel-coated balloons and paclitaxel-eluting stents. This communication updates the January 17 and March 15, 2019 notifications.


Sandoz, Inc. Issues Nationwide Recall of One Lot of Enoxaparin Sodium Injection, USP 40mg/0.4 mL Due to Temperature Excursion During Shipping

Princeton, NJ, Sandoz Inc. (“Sandoz”) is initiating a recall of one lot (SAB06761A, Exp 04/2023) of Enoxaparin Sodium Injection, USP 40 mg/0.4 mL Single-Dose Syringes to the consumer level. A portion of lot SAB06761A experienced a temperature excursion during shipment. Enoxaparin Sodium for Injectio


Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices – Letter to Health Care Providers

Recommendations for Precice devices due to ongoing biocompatibility evaluation.


UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics’ Precice Devices - Letter to Health Care Providers

The FDA is updating recommendations for NuVasive titanium-based Precice devices.


Teleflex Incorporated Announces Worldwide Recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR

Teleflex Incorporated (NYSE: TFX), a leading global provider of medical technologies for critical care and surgery, has announced a worldwide recall of Arrow-Trerotola™ Over-The-Wire PTD® Kit Percutaneous Thrombolytic Device: 7FR. The Arrow-Trerotola Percutaneous Thrombolytic Device (PTD) Catheter,


All Ultrasound Gels and Lotions Manufactured by Eco-Med Pharmaceutical, Inc. Recalled Due to Risk of Bacteria Contamination

Do not use ultrasound gels and lotions manufactured by Eco-Med, as these products are at risk for bacterial contamination.


P&G Issues Voluntary Recall of Specific Old Spice and Secret Aerosol Spray Antiperspirants and Old Spice Below Deck Aerosol Spray Products Due to Detection of Benzene

The Procter & Gamble Company is voluntarily recalling all lots with expiry through September 2023 of specific Old Spice and Secret aerosol spray antiperspirants and Old Spice Below Deck aerosol spray products sold in the United States due to the presence of benzene