Safety Recalls

15,200 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.

Showing 3,801–3,850 of 15,200

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can p

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, includi

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vita

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 24, 2025

  Edan Diagnostics

  Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are int

  As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.

  Class II

• Medical Device Recall · October 23, 2025

  Datascope Corp.

  Cardiosave Rescue

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

  Class III

• Consumer Product Recall · October 23, 2025

  Olympia Tools International, Inc. of Covina, California

  Pack-N-Stroll Premium Folding Utility Wagon

  The utility wagon violates the mandatory standard for strollers because an opening between the organizational tray and the sidewall may cause a child's head to become entrapped, posing a risk of serious injury or death. In addition, the utility wagon's lack of a restraint system poses a risk of falls to children.

  Unclassified

• Consumer Product Recall · October 23, 2025

  Scepter, of Canada

  Scepter Gas and Oil Combination Fuel Containers

  The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable gasoline fuel containers to be child resistant. The spout on the products is not child-resistant, posing a risk of burn and poisoning to children.

  Unclassified

• Consumer Product Recall · October 23, 2025

  3M Company, of St. Paul, Minnesota

  Scotch™ brand TL909-50 thermal laminator

  The recalled thermal laminators may overheat, posing a burn hazard to consumers.

  Unclassified

• Medical Device Recall · October 23, 2025

  Becton Dickinson & Co.

  BD Kiestra" Isolate Suspension Cuvette Array; Catalog No.: 246100;

  The 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a result, the instrument enters an error state and the cuvettes cannot be used.

  Class II

• Food Recall · October 23, 2025

  Echo Lake Foods, Inc.

  EchoLakeFoods MF 3067 CNFREE Cage Free Precooked IAF Scrambled Eggs Net Wt. 28 lbs. Bulk. Keep Frozen. Manufactured by: Echo Lake Foods, Inc., 2319 Raymond Ave. Franksville, WI 53126.

  Potential Listeria monocytogenes contamination.

  Class I

• Food Recall · October 23, 2025

  Ice Cream Factory, LLC

  Bakery Graham Pieces, 10 LB Label reads in part as "Ice Cream Factory, #10 Graham Pieces, Distributed by Ice Cream Factory, 1201 Ice Cream Way, Lebanon, MO 65536"

  Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

  Class II

• Drug Recall · October 23, 2025

  Zydus Pharmaceuticals (USA) Inc

  Bromocriptine Mesylate Capsules, USP, 5 mg, 30 Capsules per bottle, Rx Only. Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India. Distributed by: Zydus Pharmaceuticals, Pennington, NJ 08534. ND

  Failed Impurities/Degradation Specifications: Out of Specification (OOS) result reported for 2- Bromoergine impurity of Bromocriptine Mesylate Capsules.

  Class II

• Consumer Product Recall · October 23, 2025

  Lifepro Fitness, of Howell, NJ

  Bioremedy Infrared Sauna Blankets

  The sauna blankets can overheat, posing a burn hazard.

  Unclassified

• Consumer Product Recall · October 23, 2025

  Sauna360, Inc., of Cokato, Minnesota

  Tylö Halmstad and Kiruna Hybrid Saunas

  The saunas contain a bench that can collapse, posing a fall hazard to consumers.

  Unclassified

• Food Recall · October 23, 2025

  Ice Cream Factory, LLC

  Strawberry Cheesecake Ice Cream with graham crackers swirl, 12 oz pack, Single Cup Net Wt: 8.75oz, Case of 12 Strawberry Cheesecake with graham cracker swirl, 2.5-gal Tub, Net Weight 14 pounds Labels

  Foreign material fragments consisting of aluminum foil and packaging material were identified in brown sugar ingredient that may have been used in the products

  Class II

• Medical Device Recall · October 23, 2025

  Datascope Corp.

  Cardiosave Hybrid

  The IFU addendum updates the Vibration and Shock Table to reference the correct standards.

  Class III

• Consumer Product Recall · October 23, 2025

  Shenzhen Quanyuanfa Trading Co., Ltd. dba Bealife, of China

  Bealife 5-Drawer Dressers

  The recalled dressers are unstable if they are not anchored to a wall, posing serious tip-over and entrapment hazards that can result in injuries or death to children. The dressers violate the mandatory standard as required by the STURDY Act.

  Unclassified

• Consumer Product Recall · October 23, 2025

  Cranach Hardware, of China

  Cranach Hardware Plastic Tip Restraint Kits

  The recalled plastic tip restraint kits (also referred to as furniture straps) can break or degrade, posing tip-over and entrapment hazards that can result in serious injuries or death to children or elderly consumers interacting with furniture that is secured to the wall with the defective plastic tip restraints.

  Unclassified

• Consumer Product Recall · October 23, 2025

  Mobility Source Medical Technology Co., Ltd, of China

  LEACHOI Bed Rail

  The recalled bed rails violate the mandatory standard for adult portable bed rails because when the bed rails are attached to a bed, users can become entrapped within the bed rail or between the bed rail and the side of the mattress, posing a serious entrapment hazard and risk of death by asphyxiation. In addition, the bed rails do not bear the required hazard warning labels.

  Unclassified

• Consumer Product Recall · October 23, 2025

  J & D Brush Co., LLC of Commack, New York

  Bio Ionic One-Inch-Long Barrel Curling Iron

  The barrel of the curling iron can snap and detach, posing a burn hazard to consumers.

  Unclassified

• Consumer Product Recall · October 23, 2025

  Pro Recycle of Montreal, Quebec, Canada

  Scepter Gas and Oil Combination Fuel Containers

  The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable gasoline fuel containers to be child resistant. The spout on the product is not child-resistant, posing a risk of burn and poisoning to children.

  Unclassified

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5mm, 35 cm, Pistol Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  BioFire Diagnostics, LLC

  BioFire Respiratory Panel 2.1, IVD, REF: 423742 (30 test kit)

  Due to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 10 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Drug Recall · October 22, 2025

  Zydus Pharmaceuticals (USA) Inc

  clomiPRAMINE Hydrochloride, Capsules, USP, 25 mg, packaged in a) 30-count bottles (NDC 16714-849-01), b) 90-count bottles (NDC 16714-849-02), c) 100-count bottles (NDC 16714-849-03), Rx only, Manufact

  cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 35 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Drug Recall · October 22, 2025

  Zydus Pharmaceuticals (USA) Inc

  clomiPRAMINE Hydrochloride, Capsules, USP, 75 mg, packaged in a) 30-count bottles (NDC 16714-851-01), b) 90-count bottles (NDC 16714-851-02), c) 100 capsules, NDC 16714-851-03 Rx only, Manufactured fo

  cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

  Class II

• Drug Recall · October 22, 2025

  Zydus Pharmaceuticals (USA) Inc

  clomiPRAMINE Hydrochloride, Capsules, USP, 50 mg, packaged in a) 30-count bottles (NDC 16714-850-01), b) 90-count bottles (NDC 16714-850-02), c) 100-count bottles (NDC 16714-850-03), Rx only, Manufact

  cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 20 cm, Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 35 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 45 cm, Front-Actuated Grip Type S

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm, Pistol Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 45 cm Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat, 5 mm, 20 cm, Inline Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 22, 2025

  Olympus Corporation of the Americas

  Olympus Thunderbeat 5 mm, 35 cm, Front-Actuated Grip

  Firm is initiating a removal due to continued reports of adverse events.

  Class II

• Medical Device Recall · October 21, 2025

  Medtronic MiniMed, Inc.

  CareLink Clinic, REF: MMT-7350

  Software error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based on the incorrect data displayed on the 24-hour sensor glucose overview graph may lead to hypoglycemia or hyperglycemia.

  Class II

• Drug Recall · October 21, 2025

  Kenvue Brands LLC

  TYLENOL, Acetaminophen, Extra Strength, 24 Caplets, 500mg each, distributed by: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division, Fort Washington, PA 19034, NDC: 50580-378-04.

  Defective Container

  Class II

• Drug Recall · October 21, 2025

  Bristol-Myers Squibb Company

  Opdualag (nivolumab and relatlimab-rmbw) injection, 240 mg and 80 mg/20 mL (12mg and 4mg/mL),Single Dose Vial, RX Only, Bristol-Myers Squibb Company, Princeton, NJ 08543, NDC 0003-7125-11

  Lack of Assurance of Sterility.

  Class II

• Medical Device Recall · October 21, 2025

  Accriva Diagnostics, Inc.

  VerifyNow PRUTest Platelet Reactivity Test REF 85225 UDI-DI code: 10711234150078 The VerifyNow PRUTest is a whole blood test used in the laboratory or point of care setting to measure the level of

  Due to an device without a premarket clearance being incorrectly package and distributed.

  Class III

• Medical Device Recall · October 20, 2025

  Medtronic Perfusion Systems

  Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

  Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.

  Class II

• Drug Recall · October 20, 2025

  Golden State Medical Supply Inc.

  NIACIN Extended-Release Tablets, USP, 1,000 mg, 90 tablets per bottle, Rx only, Manufactured by: Kremers Urban Pharmaceuticals, Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274. Package

  Failed Dissolution Specifications

  Class II

• Drug Recall · October 20, 2025

  Imprimis NJOF, LLC

  Klarity-C Drops (Cyclosporine) 0.1%, Preservative-Free Sterile Ophthalmic Emulsion, This is a compounded drug, Office Use Only, 5.5 mL bottle, Rx only, Mfg by: Imprimis NJOF, LLC, 1705 Route 46 West,

  Subpotent Drug

  Class III

• Drug Recall · October 20, 2025

  ANTHONY TRINH, 123Herbals LLC

  SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China

  Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.

  Class I

• Food Recall · October 20, 2025

  Jacob King

  In-shell chicken eggs distributed on Jacob King's farm in Addison, NY

  Product may be contaminated with Salmonella

  Class I

• Medical Device Recall · October 20, 2025

  Mindray DS USA, Inc. dba Mindray North America

  Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Sev E_Vap. (Safety Filling adapter), Part Number: 115-066756-00. 2. Exchange Sev E_Vap. (

  Potential for anesthesia leakage.

  Class II

• Medical Device Recall · October 20, 2025

  Mindray DS USA, Inc. dba Mindray North America

  Isoflurane (ISO) V90 Electronic Vaporizer with the A9 Anesthesia System. Labeled as the following: 1. Iso E_Vap. (Safety Filling adapter), Part Number 115-066758-00. 2. Exchange Iso E_Vap. (Sa

  Potential for anesthesia leakage.

  Class II

• Medical Device Recall · October 18, 2025

  Auris Health, Inc

  MONARCH Bronchoscope. Model Number: MBR-000211-B

  Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

  Class II

• Medical Device Recall · October 17, 2025

  CareFusion 303, Inc.

  BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris

  If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

  Class I