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 23, 2026BEARING AND AXLE BUSHING ASSY STD ELBOW C-M113-1-301 KRH REV TIB INS 16mm THK .640…Z-3202-2026Howmedica Osteonics Corp.
September 23, 2026Thyroid Tablets, USP, 1/2 Grain (30 mg), Each tablet contains: levothyroxine (T4) 19 mcg,…D-0866-2026VITRUVIAS THERAPEUTICS INC
September 23, 2026Aisys, Datex-Ohmeda anesthesia system, Part Number 1011-9050-000Z-3189-2026Datex-Ohmeda, Inc.
September 23, 2026SOUP MIX-6/58oz Tray, PPS971 CLR PET 900/cs 32cs/pal, film-sealed (18" 16 Micron Perserva…H-1373-2026NatureBest Pre-Cut & Produce LLc
September 23, 2026Fluphenazine HCl Elixir, USP, 5 mg per 1 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol 1…D-0842-2026Safecor Health, LLC
September 23, 2026Haylard UNIV IMAGING BIOPSY TRUCUSTOM; Model/Item Number (Kit): VARV042-03;Z-3154-2026AVID Medical, Inc.
September 23, 2026Impella Optical Controller, Automated Impella Controller, Impella Connect Package with th…Z-3150-2026Abiomed, Inc.
September 23, 2026Foods Alive organic moringa leaf powder, 8oz pouch, UPC 8 91551 00092 8H-1336-2026FOODS ALIVE INC.
September 23, 2026Elegant Foods Carrot Cake, 9". 14 Servings. Keep Refrigerated/Frozen. 537 Atlas Ave., …H-1385-2026Elegant Foods, LLC
September 23, 2026Taco Dip. Ingredients: Refried Vegetarian Beans *** Guacamole (***Pico De Gallo [***Jalap…H-1349-2026Taylor Fresh Foods Inc
September 23, 2026TRIDENT 0¿ POLY INSERT 28mm ID 620-00-28D Orthopaedic implant components manufac…Z-3204-2026Howmedica Osteonics Corp.
September 23, 2026REF:B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X100MMZ-3186-2026Stryker Sustainability Solutions
September 23, 2026Oncology sets with drip chambersZ-3158-2026ICU Medical, Inc.
September 23, 2026ACETABULAR CUP UHMWPE 61-3258 ALL POLY CONSTRAINED INSERT 44MM 69-2244 ALL …Z-3201-2026Howmedica Osteonics Corp.
September 23, 2026Convenience kits ANESTHESIA PAIN PK LEAGUE DYNJ67925AZ-3207-2026Medline Industries, LP
September 23, 2026Fluphenazine HCl Elixir, USP, 2.5 mg per 5 mL, Delivers: 5 mL, Oral Elixir, PAI, Alcohol …D-0841-2026Safecor Health, LLC
September 23, 2026Salsa Verde Mild. Ingredients: Whole Tomatillos (***), Roasted Poblano Chile, Jalapeno Pe…H-1362-2026Taylor Fresh Foods Inc
September 23, 2026Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord, (1) …Z-3188-2026Boston Scientific Corporation
September 23, 2026NatureBest Mild Cheddar & Jalapeno Stuffed Mushrooms 8oz (227g) HEB SI JAL POP STFFD MUSH…H-1376-2026NatureBest Pre-Cut & Produce LLc
September 23, 2026Reign Medical Clench Staple System (Compression), Description/REF: 9mm x 7mm/152-30907;…Z-3211-2026F & A Foundation
September 23, 2026StatStrip Glucose and B- Ketone meter. Model No: 66429. Glucose test system.Z-3132-2026Nova Biomedical Corporation
September 23, 2026PEPPER-JALAPENO-DC 1/4"-4/5# PEPPER-JALAPENO-DC 1/4"-1/5# PEPPER-JALAPENO-SL 1/8"-1/5# PE…H-1375-2026NatureBest Pre-Cut & Produce LLc
September 23, 2026GM Helix Implant, REF: 109.984;Z-3173-2026Straumann USA LLC
September 23, 2026Buckhead, Tuna, 10lb cs, 12lb cs, 15lb cs, 3-5lb cs , Styrofoam container, Keep Refrigera…H-1382-2026Buckhead Meat Company D.B.A. Trinity Seafood
September 23, 2026Haylard CONTINUOUS NERVE BLOCK TRAY; Model/Item Number (Kit): BMCN001-05;Z-3152-2026AVID Medical, Inc.
September 23, 2026Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199AZ-3121-2026Medline Industries, LP
September 23, 2026ABG I ACETABULAR INSERT HOODED 28mm ID X 48mm C-M079-2-801 ARC2F ACETABULAR IN…Z-3199-2026Howmedica Osteonics Corp.
September 23, 2026REF:B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/STABILITY SLEEVE 5X75MMZ-3187-2026Stryker Sustainability Solutions
September 23, 2026Philips PIC iX Essentials REF:867093Z-3142-2026Philips North America
September 23, 2026Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;Z-3151-2026AVID Medical, Inc.
September 23, 2026Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Sh…Z-2984-2026Bard Access Systems, Inc.
September 23, 2026Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 70105442…Z-3146-2026Maquet Cardiopulmonary Gmbh
September 23, 2026Convenience kits CATARACT PACK DYNJ59881AZ-3210-2026Medline Industries, LP
September 23, 2026Centricity PACS Server V7, intended for managing digital medical images and associated da…Z-3169-2026GE Healthcare
September 23, 2026Fluphenazine HCl Elixir, USP, 10 mg per 2 mL, Delivers: 10 mL, Oral Elixir, PAI, Alcohol …D-0844-2026Safecor Health, LLC
September 23, 2026Enterprise Archive V8, software product for receiving, archiving, and sending electronic …Z-3167-2026GE Healthcare
September 23, 2026REF:2B5LT Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLE…Z-3182-2026Stryker Sustainability Solutions
September 23, 2026OMNIFIT SERIES I ACET. INSERT 10¿ 22mm ID Catalog No. 2001-2246 Orthopaedic impla…Z-3196-2026Howmedica Osteonics Corp.
September 23, 2026IV Sets with drip chambersZ-3163-2026ICU Medical, Inc.
September 23, 2026Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000Z-3191-2026Datex-Ohmeda, Inc.
September 23, 2026Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2)…Z-3123-2026Medline Industries, LP
September 23, 2026Mercer's brand 6 ICE CREAM SANDWICHES TO GO; packaged in clear plastic; ice cream sandwic…H-1343-2026Quality Dairy Farms Inc.
September 23, 2026Philips Patient Information Center iX REF:866389Z-3141-2026Philips North America
September 23, 2026Pico De Gallo Mild. Ingredients: Tomato, Yellow Onion, Jalapeno Pepper, Cilantro, Pasteur…H-1359-2026Taylor Fresh Foods Inc
September 23, 2026CADD Yellow Medication Cassette Reservoir with NRFit connector US Product Codes: 21-76…Z-3212-2026ICU Medical, Inc.
September 23, 2026Authentic Guacamole. Ingredients: Guacamole, Pico De Gallo. Spec Sheet: Guacamole (Avocad…H-1352-2026Taylor Fresh Foods Inc
September 16, 2026Halyard IV Start Kit Non-Sterile REF: KRIV26-02Z-3109-2026AVID Medical, Inc.
September 16, 2026Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone …Z-3115-2026C.R. Bard Inc
September 16, 2026Alfalfa, Net Weight 50 lbs. bag, Product of USA, International Specialty Supply 1011 Volu…H-1341-2026International Sprout Holdings, Inc
September 16, 2026Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Cathet…Z-3118-2026C.R. Bard Inc

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