A combined view of the latest available food, drug, and medical-device enforcement reports published through openFDA. Need a watchlist instead of a general feed? FDA Recall Radar monitors up to five brand, firm, or product keywords.
FOODClass I
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085315054105 Product is Perishable Frozen or Refrigerated and made by Sun Noodle Hawaii 1933 Colburn Street, Honolulu, HI
H & U Inc. dba Sun Noodle · Recall H-1258-2026 · Report 2026-09-02
Reason: Soba sauce packet, which contains bonito, sardine, and mackerel (fish), was packed into Sura Tanmen Hot and Sour Flavor ramen noodle package kit, but fish species are not declared on finished product label.
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FOODClass I
Glutinous Rice Balls with Black Sesame Filling NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000053
KHONG GUAN (HQ) · Recall H-1259-2026 · Report 2026-09-02
Reason: Undeclared peanuts.
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FOODClass II
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White Formulas, Inc. · Recall H-1278-2026 · Report 2026-09-02
Reason: Label does not declare walnuts in English
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FOODClass II
Outshine Fruit Bar Watermelon, 6-Count 2.5 ounce with UPC 041548413624, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1265-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass II
Outshine Fruit Bars Grape, 6-Count 2.5 ounce, with UPC 041548244044, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1266-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass I
Addall XR Shot 1 single bottle, 2 fl. oz., liquid dietary supplement
ZMB Enterprises · Recall H-1263-2026 · Report 2026-09-02
Reason: The product contains 1,4-DMAA, Phenylethylamine and Phenibut.
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FOODClass II
Marketside Tomato Bisque Soup Kit, Tomato Bisque with Cheese Croutons & White Cheddar Cheese, Ready to Heat, Net Wt. 14 OZ (397g), with UPC 1 94346474004. Must Keep Refrigerated.
CUISINE, KETTLE · Recall H-1271-2026 · Report 2026-09-02
Reason: Product had a presumptive positive test result for Listeria monocytogenes
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FOODNot Yet Classified
Clear glass bottle with black screw lid with multi label which reads in part as "***AFRICANDO FOODS, LLC ALFREDO HOT SAUCE, Net Weight 8 oz. ***INGREDIENTS: Habenaro Peppers, Garlic, Onions, Water, Distilled 5% White Vinegar, Spices***Manufactured and Packed By Africando Foods, LLC 1121S Gilbert Ct. Iowa City, IA 52240***"
Africando Foods LLC · Recall N/A · Report 2026-09-02
Reason: Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list
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FOODClass II
Outshine Fruit Bars Strawberry, 6-Count 2.5 ounce, with UPC 041548610047, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1264-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass II
ERIDANOUS GREEK STYLE Shortbread Cookies with apricot filling and cocoa topping with coconut sprinkles. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125846.
Lidl US TRADING · Recall H-1275-2026 · Report 2026-09-02
Reason: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
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FOODClass II
Outshine Fruit Bars Black Cherry, 6 Bars, 2.5 ounce, with UPC 041548000121, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1268-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass II
ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle Coating & Apricot Filling. Product is packed onto a plastic carton tray with outer paper sleeve, 330 g (weight), UPC: 4056489125839.
Lidl US TRADING · Recall H-1274-2026 · Report 2026-09-02
Reason: The firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat, soy, milk, eggs and tree nut (coconut).
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FOODClass II
Outshine Fruit Bars Strawberry, Pineapple, Grape, Tangerine. 24-Count 2.5 ounce, UPC 041548816678, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1269-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass I
BLACK AND WHITE GLUTINOUS RICE BALLS WITH BLACK SESAME FILLING NET WT. 14.1 OZ (400 g) Product of China UPC: 6908791000084
KHONG GUAN (HQ) · Recall H-1260-2026 · Report 2026-09-02
Reason: Undeclared peanuts.
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FOODClass I
Jalapeno Ranch, packed in 16 oz. glass jars, 6 jars per case, with UPC #199284564923.
Jaime's Foods ATX, LLC · Recall H-1301-2026 · Report 2026-09-02
Reason: Undeclared Egg Allergen
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FOODClass II
Byron White FORMULAS A-P Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White Formulas, Inc. · Recall H-1277-2026 · Report 2026-09-02
Reason: Label does not declare walnuts in English
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FOODClass II
Outshine Fruit Bars Tangerine, 6-Count 2.5 ounce, with UPC 041548612041, packaged in paper outer cartons; individual fruit bars in plastic wrapper. Keep at 0F (-18C) or colder.
Dreyer's Grand Ice Cream Inc. · Recall H-1267-2026 · Report 2026-09-02
Reason: Foreign object: products may contain glass pieces
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FOODClass II
Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Byron White Formulas, Inc. · Recall H-1276-2026 · Report 2026-09-02
Reason: Label does not declare walnuts in English
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FOODClass I
Sirna & Sons Produce PEPPER JALAPENO BREAK 1LB, repackaged into 1 lb. plastic bags, Product Number: 55255, Packed by Sirna & Sons Produce 7176 State Route 88, Ravenna, OH 44266, distributed for food service use only
Sirna and Sons Produce, Inc · Recall H-1262-2026 · Report 2026-09-02
Reason: Potential Salmonella Javiana contamination
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FOODClass II
Mehadrin Chocolate Leben; 6 OZ (170g) CUPS, UPC: 070784023144
UPSTATE NIAGARA COOPERATIVE · Recall H-1332-2026 · Report 2026-09-02
Reason: Product may have been improperly pasteurized.
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC. · Recall D-0785-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured by: West-Ward Columbus Inc., Columbus, OH 43228.
Hikma Pharmaceuticals USA INC. · Recall D-0831-2026 · Report 2026-09-02
Reason: Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-448-17.
ACCORD HEALTHCARE, INC. · Recall D-0776-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-453-17.
ACCORD HEALTHCARE, INC. · Recall D-0781-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-447-17.
ACCORD HEALTHCARE, INC. · Recall D-0775-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC. · Recall D-0782-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
Lupin Pharmaceuticals Inc. · Recall D-0789-2026 · Report 2026-09-02
Reason: Failed content uniformity specifications.
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-458-15.
ACCORD HEALTHCARE, INC. · Recall D-0786-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-449-17.
ACCORD HEALTHCARE, INC. · Recall D-0777-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
Mallinckrodt Hospital Products Inc. · Recall D-0803-2026 · Report 2026-09-02
Reason: Presence of particulate matter: glass and stopper piece
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-455-17.
ACCORD HEALTHCARE, INC. · Recall D-0783-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
Church & Dwight Co., Inc. · Recall D-0790-2026 · Report 2026-09-02
Reason: CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC. · Recall D-0784-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass I
Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
Fresenius Kabi USA, LLC · Recall D-0827-2026 · Report 2026-09-02
Reason: Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
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DRUGClass I
Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
B BRAUN MEDICAL INC · Recall D-0832-2026 · Report 2026-09-02
Reason: Presence of Particulate matter.
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DRUGNot Yet Classified
Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA
Safecor Health, LLC · Recall N/A · Report 2026-09-02
Reason: Cross Contamination with Other Products
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India.
ACCORD HEALTHCARE, INC. · Recall D-0779-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-450-17.
ACCORD HEALTHCARE, INC. · Recall D-0778-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradun-248 197, India, NDC 16729-452-17.
ACCORD HEALTHCARE, INC. · Recall D-0780-2026 · Report 2026-09-02
Reason: Subpotent Drug
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DRUGClass II
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
Apotex Corp. · Recall D-0804-2026 · Report 2026-09-02
Reason: Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
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DEVICEClass II
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
Medline Industries, LP · Recall Z-3029-2026 · Report 2026-09-02
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
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DEVICEClass II
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Medline Industries, LP · Recall Z-3028-2026 · Report 2026-09-02
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
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DEVICEClass II
Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U; 2) OPERATIVE LAP P&S SURGICAL, Medline Kit SKU DYNJ89608; 3) LAPAROSCOPY, Medline Kit SKU DYNJ903479L; 4) LAPAROSCOPY, Medline Kit SKU DYNJ903479M.
Medline Industries, LP · Recall Z-3022-2026 · Report 2026-09-02
Reason: Kits contain a potentially contaminated component which were recalled by the manufacturer
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DEVICEClass II
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
IMRIS Imaging Inc · Recall Z-3033-2026 · Report 2026-09-02
Reason: The linear actuator and rotational lock mechanism components may experience a mechanical failure that prevents the system from transitioning between locked and unlocked state. This may pose a risk of injury to the patient if unintended rotational movement occurs during a procedure.
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DEVICEClass II
Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product Number/SKU HUD78007 (Teleflex Product Number/SKU 780-07); 2) HUDSON RCI, DBM-CIRCUIT,VENT,NEONATAL,21 V, Medline Product Number/SKU HUD78009 (Teleflex Product Number/SKU 780-09); 3) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-13 (Teleflex Product Number/SKU 780-13); 4) HUDSON RCI, DBD-CIRCUIT,VENT,INSIRATORY,HEATED,NEO,4, Medline Product Number/SKU 780-14 (Teleflex Product Number/SKU 780-14); 5) HUDSON RCI, DBD-CIRCUIT, HTD, DUAL LIMB, NEONATE, Medline Product Number/SKU 780-15 (Teleflex Product Number/SKU 780-15); 6) HUDSON RCI, CIRCUIT,NEO,DUAL,WIRE,60 IN, Medline Product Number/SKU HUD7801780-18) (Teleflex Product Number/SKU 780-18).
Medline Industries, LP · Recall Z-2992-2026 · Report 2026-09-02
Reason: Neonatal and infant heated wire breathing circuits may experience sporadic failure. The heated wire connector (pigtail) at the humidifier may exhibit discoloration, melting, smoke, burning odor, or other signs of localized thermal damage. Device failure may predispose infant to bronchospasm, inspissated secretions, and airway obstruction, as well as inadvertent positive end-expiratory pressure (PEEP), circuit obstruction, or accidental lavage of pooled fluid into the airway, elevated oxygen consumption, and worsening respiratory distress.
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