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Medicine Recalls

List of Medical Device recalls in 2022. 1/6/2022

Medtronic is recalling its Synergy Cranial and StealthStation S7 Cranial software due to the potential inaccuracy of the Biopsy Depth Gauge Cycle View. 1/6/2022

Covidien, LP (part of Medtronic) is recalling its Puritan Bennett 980 Series Ventilator due to a capacitor manufacturing assembly error. 1/3/2022

Getinge/Datascope/Maquet recalls the Cardiosave IABP after complaints of fluid leaks causing the system to shut down. 12/28/2021

The FDA is updating information about Getinge?s Maquet/Datascope IABP devices including information about three voluntary recalls. 12/22/2021

False RPR Reactivity with BioPlex 2200 Syphilis Total & RPR following a COVID-19 Vaccine - Letter to Clinical Laboratory Staff and Health Care Providers 12/17/2021

Miami, Florida. Efficient Laboratories is expanding its voluntary nationwide recall to consumers to include an additional twelve lots of Rompe Pecho CF, Rompe Pecho EX, Rompe Pecho MAX, and Rompe Pecho DM due to microbial contamination concerns. These lots were distributed in 2019. To date, Efficien 12/10/2021

Colchester, VT, Edge Pharma, LLC is voluntarily recalling all lots of all drugs compounded at Edge Pharma, LLC to the consumer level. All products are being recalled due to process issues that could lead to a lack of sterility assurance for products intended to be sterile and could impact the safety 12/7/2021

Buena, NJ, Teligent Pharma, Inc. is voluntarily recalling two lots of Lidocaine HCl Topical Solution USP 4%, 50ml in a screw cap glass bottle listed in the table below to the user level. The product is being recalled because the firms testing has found it to be super potent based on an Out of Specif 12/7/2021

The 7FR PTD Kits are used to remove clots in adult patients who have arterio-venous (AV) fistulas and synthetic dialysis grafts. 12/3/2021

Foster City, CA, Gilead Sciences Inc. (Nasdaq: GILD) today announced it is voluntarily recalling two lots of Veklury? (remdesivir 100 mg for injection) to the user level. Gilead Sciences Inc. received a customer complaint, confirmed by the firm?s investigation, of the presence of glass particulates. 12/3/2021

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. 12/2/2021

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 12/2/2021

The FDA is updating recommendations for NuVasive titanium-based Precice devices. 12/1/2021

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, 11/30/2021

The FDA is reminding providers about the risk of major complications if cardiac perforation occurs during implant of leadless pacemakers 11/17/2021

SterRx, LLC today announced the voluntary nationwide recall of approximately 240 lots within their expiry period due to equipment and process issues that could lead to a lack of sterility assurance for products intended to be sterile. 11/15/2021

This update provides additional information on the recall and recommendations for people who use repaired and replaced devices. 11/12/2021

Ellume recalled its COVID-19 Home Test because they may cause false positive SARS-CoV-2 test results. 11/10/2021

Aligned Medical Solutions is recalling its custom convenience kits due to a plunger defect of the Monoject Flush Prefilled Syringe. 11/9/2021

The FDA is warning that getting alcohol-based hand sanitizer in the eyes from splashing or touching the eyes after use of hand sanitizer can result in serious injury, including severe irritation and damage to the surface of the eye. Eye exposure has occurred most often in children. 11/2/2021 10:00:00 AM

The ROSA One 3.1 Brain Application is a device that helps position and orient instrument holders or tool guides using the ROSA One 3.1 Brain Application software. 10/29/2021

Battery packs are used with the Cardiosave Hybrid/Rescue Intra-Aortic Balloon Pump to inflate and deflate intra-aortic balloons that support the left ventricle. The packs are relied on when AC power is not available. 10/29/2021

atnaturals is voluntarily recalling ten manufacturing lots of artnaturals 8oz Scent Free Hand Sanitizer. FDA testing identified 8oz bottles of Scent Free Hand Sanitizer from a single manufacturing lot: G20128A, contained several impurities. Upon being contacted by the FDA, artnaturals responded imm 10/27/2021

Aligned Medical Solutions initiated a nationwide recall of Cardinal Health?s Monoject? Flush Prefilled Saline Syringes placed into 9,378 kits. These convenience kits have been found to contain the Cardinal Health?s Monoject? Flush Prefilled Saline Syringe part # 8881570121, which has been recalled f 10/27/2021

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