FDA recalls, September 2024: 596 published

101 different companies appear this month.

Risk classification: Class I: 67 · Class II: 525 · Class III: 4

Same month, other agencies:FSIS 2 recallsNHTSA 88 recalls

Recalls this month

DateProduct
September 11, 2024Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx…D-0651-2024ProRx LLC
September 11, 2024PE Centrifuge Temperature Controlled, REF: B36366, a component of the Power Express.Z-2980-2024Beckman Coulter Biomedical GmbH
September 11, 2024Item 71117.14459, Gravy Homestyle, refrigerated product, net wt. 4lb. There are 3 packs p…F-1775-2024Reser's Fine Foods, Inc.
September 11, 2024Impella CP Pump Set, Japan; Product Code: 0048-0034-JP;Z-2956-2024Abiomed, Inc.
September 11, 2024SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug…D-0652-2024ProRx LLC
September 11, 2024Item 71117.02009, Reser's American Classics Macaroni & Cheese White Cheddar, refrigerated…F-1767-2024Reser's Fine Foods, Inc.
September 11, 2024Trilogy Evo; Model No./Model Description -- AU2110X15B Trilogy Evo, Australia BL211…Z-2944-2024Philips Respironics, Inc.
September 11, 2024Pita Jungle Greek Salad packaged in 11.8oz plastic clamshell container.F-1782-2024SSP America PHX, LLC
September 11, 2024Item 71117.14446, Potatoes Creamy Deluxe Special Request, refrigerated product, net wt. 5…F-1774-2024Reser's Fine Foods, Inc.
September 11, 2024TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, …D-0656-2024ProRx LLC
September 11, 2024Apple Danish in a clear plastic bag with a white paper label attached to the top of the p…F-1787-2024SSP America PHX, LLC
September 11, 2024Desflurane E_Vap.(Saf-T-Fill) used with the A9 Anesthesia System-Used to provide the vapo…Z-2952-2024Mindray DS USA, Inc. dba Mindray North America
September 11, 2024DxI 9000 Access Immunoassay Analyzer, REF C11137, vitro diagnostic device used for the qu…Z-1546-2024Beckman Coulter, Inc.
September 11, 2024BD Pyxis QFill Replenishment Station, REF: 138904-01, medication cabinet systemZ-2947-2024CareFusion 303, Inc.
September 11, 2024Semaglutide / Cyanocobalamin Injection: 2.5/0.5 mg/mL, 2 mL Multiple Dose Vial, Compound…D-0654-2024ProRx LLC
September 11, 2024Vivo 45 LS, pressure and volume ventilator capable of delivering continuous or intermitte…Z-2690-2024Breas Medical, Inc.
September 11, 2024BKIT BD Pyxis QFill Replenishment Station, REF: 155197-01, medication cabinet systemZ-2948-2024CareFusion 303, Inc.
September 11, 2024Impella CP Smart Assist Set; Product Code: 1000402;Z-2969-2024Abiomed, Inc.
September 11, 2024Power Express, REF B90918Z-2978-2024Beckman Coulter Biomedical GmbH
September 11, 2024Item 71117.15207, Reser's Raspberry Parfait Desserts, refrigerated product, net wt. 8lb. …F-1776-2024Reser's Fine Foods, Inc.
September 11, 2024Terrafina Golden Raisins Net Wt. 10oz (283g) UPC:847938001385. Packaged in a plastic cont…F-1794-2024SUNCO & FRENCHIE LLC.
September 11, 2024Almond Croissant in a clear plastic bag with a white paper label attached to the top of t…F-1785-2024SSP America PHX, LLC
September 11, 2024Scortisoara macinata/ Ground cinnamon, 15 g, Paper cartons, 20 pieces per paper cartonF-1779-2024MAMTAKIM, Inc.
September 11, 2024Pita Jungle Hummus & Pita Chips packaged as individual "snack pack" in 9.2oz clamshell pl…F-1784-2024SSP America PHX, LLC
September 11, 2024Impella 5.5 with SmartAssist Set, CA; Product Code: 0550-0004;Z-2962-2024Abiomed, Inc.
September 11, 2024Ham and Cheese Croissant (approximately 6.5 oz) delivered fresh in bins to the firm's Res…F-1780-2024WR Coffee Inc
September 11, 2024LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25…Z-2721-2024Fresenius Kabi USA, LLC
September 11, 2024PE Centrifuge, REF: B36365, a component of the Power ExpressZ-2979-2024Beckman Coulter Biomedical GmbH
September 11, 2024Impella CP Smart Assist Set, EU; Product Code: 0048-0014;Z-2954-2024Abiomed, Inc.
September 11, 2024Item 71117.02126, Reser's American Classics Asiago Creamed Spinach, refrigerated product,…F-1768-2024Reser's Fine Foods, Inc.
September 11, 2024Item 71117.14378, Baked Scalloped Potatoes Special Request, refrigerated product, net wt.…F-1773-2024Reser's Fine Foods, Inc.
September 11, 2024Butternut Squash Cubes - 12oz Plastic Clam-Shell ContainerF-1759-2024JFE FRANCHISING INC
September 11, 2024Chopped Cilantro with White Onion - 5oz Plastic Clam-Shell ContainerF-1760-2024JFE FRANCHISING INC
September 11, 2024Philips Azurion 7M20 systems with FlexArm ceiling-mounted system, Interventional Fluorosc…Z-2953-2024PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
September 11, 2024Impella 5.5 SmartAssist Set, JP; Product Code: 1000211;Z-2966-2024Abiomed, Inc.
September 11, 2024Impella 5.5 with SmartAssist S2 Set, US; Product Code: 1000100;Z-2965-2024Abiomed, Inc.
September 11, 2024Guacamole & Pico de Gallo Combo $7.99 - 16 oz 639123880574 Guacamole Chunky Medium - …F-1764-2024JFE FRANCHISING INC
September 11, 2024Impella CP Smart Assist Set APAC; Product Code: 0048-0047;Z-2960-2024Abiomed, Inc.
September 11, 2024Item 71117.56013, Reser's Sweet Corn with Butter, refrigerated product, net wt. 4lb. Ther…F-1778-2024Reser's Fine Foods, Inc.
September 11, 2024Trilogy Evo EV300 -- Model Number/ Model Description: BL2200X15B Trilogy Evo, O2, Benel…Z-2942-2024Philips Respironics, Inc.
September 11, 2024Popsicle Jolly Rancher Frozen Confection Pop Net Wt 2.71 FL OZ (80 ML). Green Apple Blue …F-1781-2024Unilever North America Supply Chain Company, LLC
September 11, 2024Item 71117.18531, Stonemill Kitchens Green Goddess Pasta Salad, refrigerated product, net…F-1777-2024Reser's Fine Foods, Inc.
September 11, 2024Impella 5.5 with SmartAssist Set, US; Product Code: 0550-0008;Z-2963-2024Abiomed, Inc.
September 11, 2024Impella 5.5 with SmartAssist S2 Set, EU; Product Code: 1000482;Z-2971-2024Abiomed, Inc.
September 11, 2024Item 71117.02123, Reser's American Classics Macaroni & Cheese, refrigerated product, net …F-1770-2024Reser's Fine Foods, Inc.
September 11, 2024Trilogy Evo Universal Ventilator, Model No. DS2000X11BZ-2943-2024Philips Respironics, Inc.
September 11, 2024Pico de Gallo Classic Hot - 14 oz 639123880116 Pico de Gallo Classic Medium - 14 oz …F-1762-2024JFE FRANCHISING INC
September 11, 2024Heparin, Gore Viabahn VBX, Balloon Expandable Endoprosthesis, for the following Reference…Z-2945-2024W L Gore & Associates, Inc.
September 11, 2024Impella 5.5 SmartAssist S2 Set, JP; Product Code: 1000459;Z-2970-2024Abiomed, Inc.
September 11, 2024Salsa Medium - 16 oz Salsa Mild - 16 oz Plastic Clam-Shell ContainerF-1761-2024JFE FRANCHISING INC

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