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 2, 2026PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592Z-3037-2026GE Medical Systems Information Technologies Inc
September 2, 2026PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353Z-3038-2026GE Medical Systems Information Technologies Inc
September 2, 2026Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-U…D-0790-2026Church & Dwight Co., Inc.
September 2, 2026Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Z-3008-2026AVID Medical, Inc.
September 2, 2026Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041…H-1269-2026Dreyer's Grand Ice Cream Inc.
September 2, 2026Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplementH-1263-2026ZMB Enterprises
September 2, 2026ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned,…Z-3033-2026IMRIS Imaging Inc
September 2, 2026Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit SKU CDS985246J…Z-2996-2026Medline Industries, LP
September 2, 2026Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onl…Z-2998-2026Hollister Ulc
September 2, 2026healthmark ProChek-II, Model Number PT-313, PT-201-12Z-3031-2026Healthmark Industries Co., Inc.
September 2, 2026Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.Z-2988-2026Philips Healthcare (Suzhou) Co., Ltd.
September 2, 2026Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufac…D-0776-2026ACCORD HEALTHCARE, INC.
September 2, 2026Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; …Z-3020-2026Medline Industries, LP
September 2, 2026Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 C…D-0831-2026Hikma Pharmaceuticals USA INC.
September 2, 2026Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiograp…Z-3014-2026Canon Medical System, USA, INC.
September 2, 2026Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB, repackaged into 1 lb. plastic bags, Produ…H-1262-2026Sirna and Sons Produce, Inc
September 2, 2026Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Z-3010-2026AVID Medical, Inc.
September 2, 2026Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper ou…H-1266-2026Dreyer's Grand Ice Cream Inc.
September 2, 2026Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manuf…D-0781-2026ACCORD HEALTHCARE, INC.
September 2, 2026Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJ…Z-2995-2026Medline Industries, LP
September 2, 2026Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans n…H-1277-2026Byron White Formulas, Inc.
September 2, 2026Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (N…D-0782-2026ACCORD HEALTHCARE, INC.
September 2, 2026Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manuf…D-0780-2026ACCORD HEALTHCARE, INC.
September 2, 2026POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. …Z-3035-2026Olympus Corporation of the Americas
September 2, 2026Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactu…D-0786-2026ACCORD HEALTHCARE, INC.
September 2, 2026Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstationZ-3004-2026Merge Healthcare, Inc.
September 2, 2026Midmark Digital ECG HD+12, HD+15, Model/Catalog Number: 4-000-0080 Software Version: Mid…Z-3013-2026Midmark Corporation
September 2, 2026Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) …Z-3029-2026Medline Industries, LP
September 2, 2026Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ09…Z-2994-2026Medline Industries, LP
September 2, 2026Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (J…H-1276-2026Byron White Formulas, Inc.
September 2, 2026Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes: 1) 114-3933, Mfr P…Z-3015-2026Henry Schein Inc.
September 2, 2026Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in pap…H-1264-2026Dreyer's Grand Ice Cream Inc.
September 2, 2026bettergoods brand Pistachio Nut Butter, NET WT 6.7oz (190g), UPC 194346207961H-1273-2026Botticelli Foods, LLC
September 2, 2026American Contract System Convenience Kits, CV B PACK, Model/Catalog Number: TNCB10APZ-3002-2026American Contract Systems Inc
September 2, 2026ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000…Z-3034-2026IMRIS Imaging Inc
September 2, 2026Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans…H-1278-2026Byron White Formulas, Inc.
September 2, 2026Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper…H-1265-2026Dreyer's Grand Ice Cream Inc.
September 2, 2026healthmark ProChek-W Protein Test for Robotic Arms; ProChek-Semi Quantitative Protein Tes…Z-3032-2026Healthmark Industries Co., Inc.
September 2, 2026Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in pape…H-1267-2026Dreyer's Grand Ice Cream Inc.
September 2, 2026Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 1911…Z-3017-2026Fresenius Medical Care Renal Therapies Group, LLC
September 2, 2026FUJIFILM Synapse PACS software v7.4.310; radiological image processing systemZ-3030-2026FUJIFILM Healthcare Americas Corporation
September 2, 2026Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; …Z-3024-2026Medline Industries, LP
September 2, 2026Medline convenience kits labeled as: 1) LAVH, Medline Kit SKU CDS982273U; 2) GYN ABD…Z-3027-2026Medline Industries, LP
September 2, 2026Medline convenience kits labeled as: 1) C-SECTION, Medline Kit SKU DYNJ904612L; 2) C…Z-3026-2026Medline Industries, LP
September 2, 2026Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC…D-0785-2026ACCORD HEALTHCARE, INC.
September 2, 2026Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China U…H-1259-2026KHONG GUAN (HQ)
September 2, 2026Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit SKU DYKM2330Z-2999-2026Medline Industries, LP
September 2, 2026Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Me…Z-2992-2026Medline Industries, LP
September 2, 2026Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medica…D-0832-2026B BRAUN MEDICAL INC
September 2, 2026Halyard TOTAL JOINT Model/Catalog Number: MSBM036-03Z-3007-2026AVID Medical, Inc.

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