2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. 510(K) Database Search A recall is an action taken to address a problem with a medical device that violates FDA law. Recall Summaries. January 4, 2021 -- Essaar Inc. is voluntarily recalling lot 200528303 of Soho Fresh 70% Rubbing Alcohol in 33.81 oz. Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Num... 2 10/01/2020 Riverpoint Medical, LLC Z-2451-2019 - Natrelle, Saline-Filled Breast Implant Biocell Full Height with Fill Tube, Sterile, for the following style numbers: Style 163:163-360CC, 163-440CC, 163-530CC, 163-655CC, 163-780CC; Style 168:1... 1 09/11/2019 Allergan PLC Z-2465-2019 - Natrelle 150 Full Height and Short Height Implants, BIOCELL, INTRASHIEL, BioDIMENSIONAL Breast Implant, Styles 150 FH and 150 SH. After an establishment completes a recall, it will be removed from the current recalls listing and added to this online archive. The Database is searchable for therapeutic good recall action notifications that include recalls , product defect corrections and hazard alerts (implanted … The Database holds information on recall actions that have been undertaken in Australia since 1 July 2012. The investigation is ongoing, and the scope of the recall may expand as new information becomes available, the FDA said. Allen Kim contributed to this report. After an FSIS recall is completed, it will be removed from this listing, but will be included in the Recall Case Archive. * Information on recalled foods other than meat (including fish of the order Siluriformes), poultry, or processed egg products is available from the Food and Drug Administration website or from FoodSafety.gov . Connect to recalls, alerts, and warnings provided by other Federal and State agencies. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. Annual summaries list all the cases for a given year whether they are open or archived. Z-2224-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (20 mm) 9630TF20 UDI:00690103201239 1 08/21/2019 Edwards Lifesciences, LLC Z-2227-2019 - Edwards SAPIEN 3 Ultra Transcatheter Heart Valve System (SAPIEN 3 Ultra Delivery System) (29mm) 9630TF29 UDI:00690103201260 1 08/21/2019 Essaar Inc. Issues Voluntary Nationwide Recall of Rubbing Alcohol Contaminated with Methanol. For information about recall cases from prior years, select another year from the drop-down menu above. Learn more about medical device recalls. Find information on recalls of products regulated by the Food and Drug Administration. The Recall Enterprise System (RES) is an electronic data system used by FDA recall personnel to submit, update, classify, and terminate recalls. The FDA posts summaries of information about the most serious medical device recalls. 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