Safety Recalls
RSS ↗17,560 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 5,401–5,450 of 17,560
- Class II
Food Recall · October 23, 2025
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
Medical Device Recall · October 22, 2025
Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4, 6.0.5, 6.0.6 Product Description: The DASH¿ Rapid PCR InDue to a software issue
- Class II
Medical Device Recall · October 22, 2025
Olympus Corporation of the Americas
Olympus Thunderbeat 5 mm, 10 cm, Inline GripFirm 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 GripFirm is initiating a removal due to continued reports of adverse events.
- Class II
Medical Device Recall · October 22, 2025
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, 45 cm, Front-Actuated Grip Type SFirm 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 GripFirm 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 GripFirm 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 GripFirm 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 SFirm 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, Front-Actuated GripFirm 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, 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, ManufactcGMP 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, 35 cm, Inline GripFirm 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 GripFirm 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, ManufactcGMP 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, 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 focGMP 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 Type SFirm is initiating a removal due to continued reports of adverse events.
- Unclassified
Vehicle Recall · October 22, 2025
2024 ISUZU FTRA detached axle stabilizer bracket can create a road hazard for other vehicles, increasing the risk of a crash.
- Class II
Medical Device Recall · October 22, 2025
Olympus Corporation of the Americas
Olympus Thunderbeat, 5mm, 35 cm, Pistol GripFirm is initiating a removal due to continued reports of adverse events.
- Class II
Medical Device Recall · October 21, 2025
CareLink Clinic, REF: MMT-7350Software 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
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 III
Medical Device Recall · October 21, 2025
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 ofDue to an device without a premarket clearance being incorrectly package and distributed.
- Class II
Drug Recall · October 21, 2025
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 0003-7125-11Lack of Assurance of Sterility.
- Unclassified
Vehicle Recall · October 21, 2025
2024 FIAT 500EImproperly adjusted headlights can reduce driver visibility or create a glare for oncoming traffic, increasing the risk of a crash.
- Unclassified
Vehicle Recall · October 21, 2025
2024 HOLIDAY RAMBLER INVICTA, 2026 HOLIDAY RAMBLER INVICTAAn inability to access the LP compartment can increase the risk of a fire.
- Class II
Medical Device Recall · October 20, 2025
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03Medtronic 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
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. (SaPotential for anesthesia leakage.
- Class I
Food Recall · October 20, 2025
In-shell chicken eggs distributed on Jacob King's farm in Addison, NYProduct may be contaminated with Salmonella
- Class II
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
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. PackageFailed Dissolution Specifications
- Class I
Drug Recall · October 20, 2025
SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, ChinaMarketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
- Class II
Medical Device Recall · October 18, 2025
MONARCH Bronchoscope. Model Number: MBR-000211-BPotential 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
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 16 cm;A potential issue with the seal integrity of header bag packaging.
- Class II
Medical Device Recall · October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Safety Components: 12 Fr/Ch (4.0 mm) x 24 cm;A potential issue with the seal integrity of header bag packaging.
- Class II
Medical Device Recall · October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 24 cm;A potential issue with the seal integrity of header bag packaging.
- Class I
Medical Device Recall · October 17, 2025
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 AlarisIf 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 II
Food Recall · October 17, 2025
CaBOT CREAMERY SEA SALT CARAMEL CHEDDAR SWEET & CHEESY POPCORN 6.0oz bag CONTAINS: SOY & MILK UPC 8 50016 94430 6 MANUFACTURED FOR: VERMONT CHEESE PRODUCTS, INC 60 LAKE STREET, SUITE 2A BURLINGTON, VTUndeclared Peanuts. The firm received two complaints that the product contains peanuts which are not listed in the ingredient statement.
- Class II
Food Recall · October 17, 2025
Cinnamon Powder; 8oz clear plastic container. Distributed by Haitai Inc. UPC: 0 20914 81415 9Elevated levels of lead in Cinnamon powder.
- Class II
Drug Recall · October 17, 2025
Acetaminophen 500mg Caffeine 65mg caplets, packaged as 2 caplets per packet further packaged in a 50-count box, AERO TAB, Manufactured for AERO HEALTHCARE US, Valley-Cottage, NY, 10989, NDC 55305-135-Labeling: Label Mix-up. This issue affects the outer box labeling only. The box incorrectly states the ingredients Acetaminophen 500mg and Caffeine 65mg. The inner pouch correctly states the ingredients are Aspirin (NSAID)*500mg and Caffeine 32.5mg.
- Class II
Medical Device Recall · October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Straight Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;A potential issue with the seal integrity of header bag packaging.
- Class II
Medical Device Recall · October 17, 2025
Olympus Corporation of the Americas
Brand Name: EZDilate Nephrostomy Balloon Catheter and Inflation Device Kit Product Name: Olympus Nephro-EZDilate Nephrostomy Balloon Catheter Model/Catalog Number: BPCN0815K Product Description: ThDevice kits contained an incorrectly sized 4mm x 4cm urinary tract balloon catheter (BURS0404) instead of the correct 8mm x 15cm nephrostomy tract balloon catheter (BPCN0815). All other components in the kits were correctly included and packaged in the kit.
- Class II
Medical Device Recall · October 17, 2025
TECHNO-PATH MANUFACTURING LTD.
Multichem ID-B. Model Number: SR103B. Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determination ofPotential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
- Class II
Medical Device Recall · October 17, 2025
INTELERAD MEDICAL SYSTEMS INCORPORATED
IntelePACS - InteleConnect / TechPortalSoftware application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that could cause data loss in Relevant Clinical Info field when modifying studies through Case Editor in either Technologist Portal or Referring Physician Portal, which could result in loss of clinical information, which could impact clinical decision-making.
- Unclassified
Vehicle Recall · October 17, 2025
2025 THOR MOTOR COACH QUANTUM, 2026 THOR MOTOR COACH FOUR WINDSA LP hose that contacts the generator exhaust increases the risk of a fire.
- Class II
Food Recall · October 17, 2025
Town Food Service Equip Co Inc
Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580Product found to contain leachable lead levels.
- Class II
Medical Device Recall · October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 13 cm;A potential issue with the seal integrity of header bag packaging.
- Class II
Medical Device Recall · October 17, 2025
TECHNO-PATH MANUFACTURING LTD.
Multichem ID-B. Model/Catalog Number: SR103B Intended for use as an unassayed positive qualitative quality control serum to monitor the precision of laboratory testing procedures for the determinatPotential of negative recovery of the HBsAg analyte across two (2) lots of Multichem ID-B Positive Control when tested on the Alinity i platform.
- Class II
Medical Device Recall · October 17, 2025
MAHURKAR" Acute High Pressure Triple Lumen Catheter Tray Curved Extensions with IC Components: 12 Fr/Ch (4.0 mm) x 20 cm;A potential issue with the seal integrity of header bag packaging.
- Unclassified
Vehicle Recall · October 17, 2025
2025 FOREST RIVER SALEM, 2025 FOREST RIVER WILDWOODA tire can be overinflated after referencing the incorrect information, increasing the risk of a crash.