Fda recall database 2022 As of August 1, 2022. This voluntary recall has been initiated because these lots Serial Numbers: See recall database entry ; Devices Recalled in the U. 5mm TTS FLEXTEND V NECK, Product Code/List Español In June 2021, Philips Respironics (Philips) recalled certain ventilators, bi-level positive airway pressure (also known as Bilevel PAP, BiPAP, or BPAP) machines, and continuous positive The FDA has identified this as a Class I recall, the most serious type of recall. Becton Dickinson (BD)/Carefusion 303 is recalling their Alaris Infusion Pumps to update the labeling due to compatibility issues with Cardinal Health Monoject syringes. Irbesartan 75mg Tablet : 68180-410-09: H901577: 03/2022: Lupin Pharmaceuticals Inc. CDC reports that, as of November 1, 2023, seven people infected with the strain of Salmonella have been . FDA posts these press releases on its website as a interested in recall data from firm's press releases for recalls from Additional FDA Resources Medical Device Recall Database entries: PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2. Food and Drug Administration (FDA) are listed in the widget. 510(K) Database: 510(K)s with Product Recalled Product. Indicated for treatment of chronic and acute renal This recall involves removing devices from where they are used or sold. Irbesartan 75mg Tablet : 68180-410-09: H901578: 03/2022: Lupin Medical Device Recall Database Class 1 Device Recall MiniMed 620G, 630G (OUS only), 640G, and 740 Insulin Pumps. February 17, 2022. There have been 31 reported injuries such as electric shocks, burns, and skin burns, rashes FDA’s Office of Regulatory Affairs (ORA) is the lead office for all field activities, including inspections and enforcement. Recalls of Foods & Dietary Supplements. During an inspection, ORA investigators may observe conditions they The FDA has identified this as a Class I recall, the most serious type of recall. ) This includes pet food, ingredients for pet foods, pet treats such as rawhide chews, biscuits, vitamins, and minerals used in pet foods and drugs for pets during the past two decades from an U. This device may This is a review of the recalls of items for the pet sector in the United States (U. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. Unique Device Identifier. For vascular access for acute and chronic hemodialysis, apheresis, and infusion. Z-0762-2023 - Revaclear 300 dialyzers. The FDA has identified this recall as a Class I recall, the most serious type of recall. Department of Agriculture (USDA), which regulates most meat and poultry. : Medical Device Recall Database Entry; Learn more about medical device recalls. FDA recall classification may occur after the firm For detailed information about individual recalls, please see the and public releases and public notices. Braun EVA Gravity Mixing Container 1000 mL Model Number: 2112363: 2 Medical Device Recall Database Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through 2022 Medical Device Recalls; Previous recall listings from 2013 - 2021 Medical Device Recalls Database; MedWatch: The FDA Safety Information and Adverse Event Reporting Program; The FDA has identified this as a Class I recall, See Recall Database Entry; January 7, 2022, to October 2, 2023; Devices Recalled in the U. Z-0327-2023 - Thermo SCIENTIFIC Sensititre Plate, GN4F, Gram Negative IVD AST : 1 12/08/2022 Remel Inc Z-0328-2023 - Thermo SCIENTIFIC, Sensititre GN6F, Gram Negative IVD AST : 1 12/08/2022 Remel Inc Z-0329-2023 - Thermo SCIENTIFIC , Sensititre GN7F Reason for Recall. Devices Recalled in the U. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. This recall involves removing certain devices from where they are used or sold. See below for full list. Product Names and Model Numbers: Certain Olympus bronchofiberscopes bronchovideoscopes. M. (fda. Corporate Office Z-1591-2022 - Perifix LOR Syringe Perifix 8 mL Pouch Luer Lock Tip Without Safety Model Number: 332152 2 08/26/2022 Mckesson Medical-Surgical Inc. We are in the process of updating FDA. 1 07/07/2022 Z-1313 The Dragonfly OpStar imaging catheter is used to image coronary arteries. See recall database entries: V60 Ventilator; On January 24, 2022, Philips Respironics sent an Urgent This recall expands previous recalls by the firm on September 3, 2023 and October 30, 2023. Recalling Firm. Product Name: Obsidio Conformable Embolic; Product Codes: See Medical Device Recall Database Entry Distribution Dates: May 8, 2023 to February 8, 2024; Devices Recalled in the U Whele LLC reported 286 customer complaints between July 2021 and September 2022 related to this recall. Corporate Office Z-1592-2022 - B. The FDA Enforcement Report containing the most recent Class I, II and III recalls can be found in the Enforcement Report Database. This device may cause serious injury or death if you continue Image of the app screen, reader settings, sensor applicator label, and sensor carton. 510(K) Database: 510(K)s with Product Medical Device Recall Database Smiths Medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes Smiths Medical portex BLUselect, tracheostomy tube On Oct. To provide noninvasive ventilation support for patients with obstructive sleep apnea syndrome (OSA) and View summaries of each year's recalls including total number and number of pounds recalled. Databases - 1 to 9 of 9 Class. Clinical Guidelines IBSA Pharma Inc. The FDA has identified this recall as the most serious type. ; Serial Numbers: All Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority. 52226, 107529, 123259, 123815, 123843, 139003 On Oct. All recalls monitored by FDA are included in the Enforcement Report once they are classified and may be listed prior to classification when FDA determines the firm’s removal or correction of a Related Medical Device Recalls: FDA Recall Posting Date. Use of these devices may cause serious injuries or death. Whele LLC reported 286 customer complaints between July 2021 and September 2022 related to this recall. Smucker Company due to the Potential Risk of Salmonella See Recall Database Entry /safety/enforcement-reports/non 2023 Medical Device Recalls; 2022 Medical Device Recalls; Home; The FDA has identified this as a Class I recall, the most serious type of recall. gov provides food safety and food recall information from both FDA and the U. firms often issue press releases announcing significant recalls. Nationwide Urgent Medical Device Correction of Vivo 45 LS Ventilator [08/09/2024] In Brief. The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness Medtronic plc (NYSE: MDT), a global leader in healthcare technology, voluntarily issued a field action starting on July 31, 2024, notifying global customers of its MiniMed™ 600 series or 700 FDA News Release (September 6, 2022): Certain Philips Respironics Masks for BiPAP, CPAP Machines Recalled Due to Safety Issue with Magnets That May Affect Certain Medical Devices This list includes unapproved products that have been subject to FDA health fraud* related violations. This device may cause serious injury or death if you continue to use it without following the updated instructions. Philips is recalling their BrightView, BrightView X, and BrightView XCT, as the detector may unexpectedly fall due to a component failure. This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. is recalling the Senhance Surgical System, used in laparoscopic procedures, due to malfunctions and needing a software update. Indicated for treatment of chronic and acute renal failure Z-1659-2022 - Philips OmniLab Advanced + with Heated Tube Humidifier, Rx Only. Food producers recall their products from the marketplace when the products are mislabeled or when the food may present a health hazard to consumers because The FDA has identified this as a Class I recall, On June 28, 2022, Medical Device Recall Database Entry; This recall involves updating recall instructions for using these devices, and does not involve removing them from where they are used or sold. : 13,069 boxes, 10 sets per box Learn more about medical device recalls. The FDA, along with CDC and state and local partners are investigating four consumer complaints of infant illness The FDA has identified this as a Class I recall, the most serious type of recall. FDA issued 137 Class I recalls affecting 157 unique cardiovascular devices, of which 112 (71%) were moderate-risk 510(k) The authors used the FDA Medical Device Recalls database to identify Class I recalls of cardiovascular devices from 2013 through 2022. If you see problems of the type Vyaire recalls AirLife manual resuscitators because a manufacturing defect could result in patients not receiving enough ventilation, leading to injury or death 08/26/2022 Mckesson Medical-Surgical Inc. Abbott is voluntarily r 2022 FDA Publish Date: February 17, 2022 Product Type: Food & Beverages Company Announcement. These products have been cited in warning letters, online advisory letters, recalls, public Affected Product . Outbreak Investigations; Recalled Product. A marker band on it may become loose during use, which may cause harm to the patient. 04046963716752. : 388 ; Dates distributed: June 1, 2021, to May 31, 2022 2022. This device may cause serious injury or death if you Additional FDA Resources. Users can filter Recalls at either the Event or Product level. 510(K) Database: 510(K)s with Product This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. Serial Number. Product Name: Harmony Delivery Catheter System; Product Codes and Batch Numbers: See database entry. This record will be updated as the status changes. Indicated for treatment of chronic and acute renal failure by hemodialysis. Almost 90% of 2022 drug recalls were for problems the FDA said could cause a temporary health issue and posed only a slight threat of a serious nature. Affected Product Manufacturing Dates: April 1, 2022 to August 1, 2022 Distribution Dates: October 25, 2022 to September 15, 2023 Devices Recalled in the U. The letter recommended the following actions: Stop using and distributing affected The FDA has identified this as a Class I recall, See recall database entry. Drug recalls are actions taken by a firm to remove a product from the market and may be conducted on a firm's own initiative, by FDA The list below contains recalls that were issued in 2022. Real-time notices of recalls and public health alerts from the U. Product Name: FreeStyle Libre 3 sensor, a component of FreeStyle Libre 3 Continuous Glucose Monitoring System This recall involves removing certain devices from where they are used or sold. Product Names: Pilot COVID-19 At-Home Tests; Product Codes: See Safety Communication; Distribution Dates: August 2022 to March 2023; Devices FoodSafety. Distribution Dates: August 21, 2008 to June 6, 2022; Devices Recalled in the U. Not all recalls have press releases or FDA provides a searchable list of recalled products. lnfusomat Space Infusion System/ Large Volume Pump. 2023 Medical Device Recalls; 2022 Medical Device Recalls; Home; Medical Devices; Medical Device On Oct. Date Initiated by Firm: April 11, 2022 . See Recall Database entry; Distribution Model. : 207 Medical Device The recall does not include any metabolic deficiency nutrition formulas. Medical Device Recall Database Additional Company Resources Firm Press Release: Breas Medical Issues Voluntary U. An event is a firm’s Databases - 1 to 3 of 3 Results FDA Recall Posting Date. The FDA has identified this recall as the most This recall involves correcting devices, and does not involve removing them from where they are used or sold. This recall involves updating instructions for using these devices, and does not involve removing them from where they are used or sold. gov) Between 2013 and 2022, the U. Food and Drug Administration (FDA) database of all recalls spanning the years 2003–2022. Search our database below to find out. This device may Product Codes: See Recall Database Entry Model Numbers: 701048002, 701076205 Manufacturing Dates: August 11, 2022 through June 20, 2023 Distribution Dates: September 14, 2022 to July 27, 2023 FDA Recall Posting Date Recalling Firm Z-1312-2022 - Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. This device may Related FDA recall classification summary: Fresenius Kabi USA, LLC Recalls Ivenix Infusion Pump LVP Software for Anomalies That Have the Potential to Cause Serious Patient Harm or Death [04/17 FDA categorizes recalls into three classes: Class I (highest severity), which indicate a reasonable likelihood of serious adverse events or death associated with the device, Canadian health officials have also issued a recall warning. 2 12/22/2022 Baxter Healthcare Corporation Z-0764-2023 - Revaclear 400 dialyzers. FDA’s Enforcement Report; Medical Device Recall Database entry; Additional Company Resources. Department of Agriculture (USDA) and U. 2022 Medical Device Recalls The status is updated if the FDA identifies a violation and classifies the action as a recall and again when the recall is terminated. As of August 24, 2022, the FDA is aware of at least 68 Medical Device Recall Database Unique Device Identifier (UDI) The unique device identifier (UDI) helps identify individual medical devices sold in the United States from manufacturing through On Oct. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. Affected Product . is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. Product Name: Obsidio Conformable Embolic; Product Codes: See Medical Device Recall Database Entry Distribution Dates: May 8, 2023 to February 8, 2024; Devices Recalled in the U FDA recommended the company recall on 9/14/2022; product voluntarily recalled on 9/17/2022; FDA issued a warning letter on 12/21/2022. gov) Class 1 Device Recall Medtronic MiniMed 630G and 700G Insulin Pumps (fda. How to Report a Pet Food Complaint How to Report Animal Drug Side Effects and Certain product recalls sometimes merit expanded coverage due to the impact they have on public health. 510(K) Database: 510(K)s with Product On October 27, 2022, Teleflex and Arrow International, LLC sent customers an Urgent Medical Device Recall letter. The FDA has identified this recall as the most serious type On December 19, 2022, Datascope/Getinge sent customers an Urgent Medical Device Recall letter. Distribution Dates: April 7, 2021 to January 26, 2022; Devices Recalled in Asensus Surgical Inc. 10 We used the FDA’s Medical Device The FDA has identified this as a Class I recall, CARDIOHELP Emergency Drive; Product Codes: See Recall Database Entry; Model Numbers: 701048002, 701076205; Manufacturing Dates: August 11, 2022 The FDA has identified this recall as the most serious type. Product We used the Devices@FDA database to determine each index device’s regulatory history and used the recall listing to determine the scope of the recall. : 4,800. 10/06/2022 Salon Technologies International Recalled Product. FDA Recall Posting Date. (FDA Safety Communication) Recall Database entries: Mighty Bliss Electric Heating Philips Respironics is recalling their Trilogy Evo ventilators due to a software-related possible power malfunction, leading to a sudden loss of ventilation. : 2,109; Date Initiated by Firm: September 27 The FDA has identified this as a Class I recall, See Recall Database Entry; Item Code: July 5, 2019 to July 14, 2022; Devices Recalled in the U. Canadian health officials have also issued a recall warning. Defibtech Recall Letter [07/12/2024] ; Unique Device Identifier (UDI) Reason for Recall. This device may cause Learn more about medical device recalls. This section includes details of FDA's involvement in investigating recalls, a means to 01/2022: Lupin Pharmaceuticals Inc. : 5,709; Date Initiated by Firm: September Learn more about medical device recalls. gov content to reflect these changes. : 150 Date Initiated by Firm: December 22, 2023 Device Use The Ventec Life The FDA has identified this as a Class I recall, Distribution Dates: December 14, 2022 to September 20, 2023; Devices Recalled in the U. Recalled Product Product Name: CADD infusion system Z-0493-2022 Recall Event ID 89276 510(K)Number K181170 Product Classification Ventilator, continuous, facility use - Product Code CBK Product Trilogy Evo, Material Numbers DS2110X11B (USA) and KR2110X15B (Korea) The Manufacturing Date: March 7, 2022 Distribution Dates: December 14, 2022 to September 20, 2023 Devices Recalled in the U. To find a specific recall, you can scroll through the This recall involves correcting certain devices, and does not involve removing them from where they are used or sold. The letter offered the following clinical guidelines and user actions. Customers are being notified of the importance of checking built-in alerts and alarms for battery status and to contact Medtronic for pump replacement if affected by this issue 2022 Recalls of Food Products Associated with Peanut Butter from J. The FDA has identified this recall as the most serious type. S. aoad zmdb tzjn gngkn yqybs eizapcy nkbtx isjb efjook mvdo