The FDA has announced a Class I recall, the most serious type of recall, of all lots of Endologix Ovation iX Abdominal Stent Graft System manufactured from 2015 to the present, which involves 5,403 such medical devices. The Ovation iX… Read More
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Class I Recall Of More Than 322,000 Medtronic MiniMed Insulin Pumps For Incorrect Insulin Dosing
The FDA announced on February 12, 2020 a Class I recall of 322,005 MiniMed 600 Series Insulin Pumps Model 630G (MMT-1715) (all lots before October 2019) and Model 670G (MMT-1780) (all lots before August 2019). The distribution dates for Model… Read More
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Medtronic Issues Recall Of Its 6 French Sherpa NX Active Guide Catheters Due To Separation And Fragmentation Issue
Medtronic announced on October 8, 2019 that it was recalling its 6 French Sherpa NX Active Guide Catheters due to a separation and fragmentation issue. The 6 French Sherpa NX Active Guide Catheter is used to access veins and arteries… Read More
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Alaris™ Pump Modules Model 8100 Recalls
In a recall notification sent on April 15, 2019, Becton, Dickinson and Company (“BD”) informed clinicians that the bezel assemblies in certain Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017 were manufactured with a specific type… Read More
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Medtronic Issues Urgent Recall Of Nearly 157,000 Dual Chamber Pacemakers
Medtronic has issued an “Urgent Medical Device Recall” voluntarily recalling and suspending distribution of a subset of Medtronic dual chamber pacemakers distributed worldwide between March 10, 2017 and January 7, 2019 under the brand names Adapta; Versa; and Sensia. The… Read More
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Report Finds Pharmaceutical Recalls And Medical Device Recalls Were Up In First Quarter 2018
The First Quarter 2018 “Recall Index” published by Stericycle Expert Solutions (“Stericylce,” which “provides global and local expertise before, during, and after a recall threat” and each quarter of the year analyzes cumulative recall data across five product categories), reported… Read More
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AVAIRA Toric Soft Contact Lenses Recalled
The FDA has announced a Class 1 recall for AVAIRA Toric (enfilcon A) TORIC Soft (Hydrophilic) Contact Lenses, 6 Soft Contact Lenses for Astigmatism. A Class 1 recall is the most serious type of recall and involves situations in which… Read More
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Medical Device Recalls Need Better Oversight
The evaluation and approval of medical devices used in the United States come under the oversight of the U.S. Food and Drug Administration (FDA). The FDA does not only oversee the approval of medical devices but also oversees the recalls of medical… Read More
