FDA recalls, September 2026: 385 published

122 different companies appear this month.

Risk classification: Class I: 90 · Class II: 279 · Class III: 16

Same month, other agencies:CPSC 50 recallsFSIS 6 recallsNHTSA 28 recalls

Recalls this month

DateProduct
September 16, 2026Kit: Epidural/Pain TQC 20/Cs, REF: 82465 Containing Sodium Chloride Injection, 0.9%, USP …Z-3106-2026Medical Action Industries, Inc. 306
September 16, 2026Crown Farms Dried Suri Cut, 200 gm, in plastic pack, 25 packages per box, keep frozenH-1331-2026EURO FOODS GROUP USA NJ INC
September 16, 2026Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16…Z-3111-2026Atrium Medical Corporation
September 16, 2026Products that contain the Pericare Wipes: Bardex Lubricath Foley Catheter Tray REF: …Z-3114-2026C.R. Bard Inc
September 16, 2026AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394BZ-3138-2026Windstone Medical Packaging, Inc.
September 16, 2026Getinge PVC Thoracic Catheter, Firm PVC Straight, 10 per Case; Size(Model Number): 1. 28…Z-3113-2026Atrium Medical Corporation
September 16, 2026Momchipz Gluten Free Veggie Chips Broccoli Florets & Cauliflower, net wt. 3oz (85g). UPC …H-1330-2026EXOTIQUE FOODS CANADA
September 16, 2026Bravo CF capsule delivery device, 5-pack, Product Number FGS-0635, Bravo CF capsule d…Z-3090-2026Given Imaging Ltd.
September 16, 2026Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bott…D-0835-2026ImprimisRx NJ LLC
September 16, 2026Getinge PVC Thoracic Catheter, Soft PVC Right Angle, 10 per Case; Size(Model Number): 1.…Z-3112-2026Atrium Medical Corporation
September 16, 2026Fannie May & XO Marshmallow Pixie S'mores Collection, 4.47ozH-1334-2026Ferrero USA
September 16, 2026fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag…D-0864-2026OurPharma LLC
September 16, 2026MedicaLyte Bicarbonate Powder REF: DB+201-2.1(45X) and DB+201-25 (35X, 36.83X, 45X))Z-3134-2026Nipro Renal Soultions USA, Corporation
September 16, 2026Citric Complete Liquid Citric Acid Concentrate REF: LC+200-D,LC+201, LC+225(45X)Z-3136-2026Nipro Renal Soultions USA, Corporation
September 16, 2026Prolon Everyday Apulian Almond & Cocoa Spread, NET WT: 8.47 OZ. Product packaged in glass…H-1335-2026L-Nutra Inc
September 16, 2026Products that contain the Pericare Wipes: (Canada Only) SureStep" Foley Tray System Barde…Z-3119-2026C.R. Bard Inc
September 16, 2026Epinephrine Injection, USP, 30 mg/30 mL (1mg/mL), 30 mL-Multiple-Dose Vial, Rx Only, For …D-0865-2026American Regent, Inc.
September 16, 2026Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: A…D-0836-2026Ajanta Pharma USA Inc
September 16, 2026Citric Complete Dry Citric Acid Concentrate REF: DCA+200-25 & DCA+203-25Z-3135-2026Nipro Renal Soultions USA, Corporation
September 16, 2026Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerf…D-0850-2026Baxter Healthcare Corporation
September 16, 2026MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201Z-3133-2026Nipro Renal Soultions USA, Corporation
September 16, 2026HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067 …Z-3120-2026HeartSine Technologies Ltd
September 16, 2026Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device t…Z-3110-2026Lutronic Corporation
September 16, 2026Products that contain the Pericare Wipes: SureStep Intermittent Catheter Tray REF: INTP1…Z-3117-2026C.R. Bard Inc
September 16, 20260.9% Sodium Chloride Injection, USP, 100 mL Partial Fill in 150 mL PAB Container, Sterile…D-0869-2026B BRAUN MEDICAL INC
September 16, 2026Kit: Single Shot Epidural 20/Cs, REF: 59553; Kit: Single Shot Epidural 20/Cs, REF: 83945…Z-3107-2026Medical Action Industries, Inc. 306
September 16, 2026Products that contain the Pericare Wipes: *Bardex¿ I.C. Complete Care¿ Foley Catheter Tr…Z-3116-2026C.R. Bard Inc
September 9, 20262% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3…D-0837-2026Sage Products, LLC
September 9, 2026Velys Enabling Tech Robotic-Assist Station REF: 451611001Z-3088-2026Medos International Sarl
September 9, 2026MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL),…D-0806-2026Baxter Healthcare Corporation
September 9, 2026Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Do…D-0812-2026Baxter Healthcare Corporation
September 9, 2026traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croati…D-0834-2026Teva Pharmaceuticals USA, Inc
September 9, 2026Medline Convenience Kits: 1) IVS BLOOD CULTURE KIT, Model Number: DYNDH1920; 2) IVS BL…Z-3051-2026Medline Industries, LP
September 9, 2026STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitati…Z-3047-2026Diagnostica Stago, Inc.
September 9, 2026Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg t…D-0821-2026Baxter Healthcare Corporation
September 9, 2026Wonton Specialist Inc. Cooked Noodle, 16 oz and 5 lb - packaged in clear plastic bagsH-1325-2026Wonton Specialists
September 9, 2026Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1…Z-3095-2026Cardinal Health 200, LLC
September 9, 2026Organic Cheddar Type Seasoning, NET WT: 50 lbs. Product is packaged in bulk poly-lined pa…H-1319-2026Savor Seasonings LLC
September 9, 2026Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Asc…D-0851-2026OPTIMAL BALANCE PHARMACY
September 9, 2026Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV…Z-3056-2026Medline Industries, LP
September 9, 2026Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan…D-0839-2026Mylan Pharmaceuticals Inc
September 9, 2026Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTUR…Z-3070-2026Medline Industries, LP
September 9, 2026Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRA…Z-3079-2026Medline Industries, LP
September 9, 2026Baxter Novum IQ Syringe Pump, Loaner, Model Number 40800BAXUSLZ-3066-2026Baxter Healthcare Corporation
September 9, 2026Medline Convenience Kits: 1) DRAWER 9 CRICOTHYROTOMY KIT, Model Number: ACC010741; 2) …Z-3048-2026Medline Industries, LP
September 9, 2026Medline Convenience Kits: 1) C-SECTION PREP, Model Number: DYNJ32702BZ-3060-2026Medline Industries, LP
September 9, 20265008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8Z-3087-2026Fresenius Medical Care Renal Therapies Group, LLC
September 9, 2026HEALON EndoCoat PRO, REF: 10300012 (US/CAN) HEALON DUET PRO II, REF: 10300016 (US/CAN) …Z-3064-2026Johnson & Johnson Surgical Vision, Inc.
September 9, 2026Medline Convenience Kits: 1) ULTRASOUND BREAST PACK, Model Number: DYNJ63375CZ-3053-2026Medline Industries, LP
September 9, 2026OLA-OLA Pounded Yam (Iyan) IYANINSTANT, NET WT. 2 lbs., 4 lbs., 5 lbs., 10 lbs, packed in…H-1329-2026Fayus Inc.

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