Safety Recalls
RSS ↗17,560 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 4,701–4,750 of 17,560
- Class III
Drug Recall · November 26, 2025
Cisatracurium Besylate Injection USP, 10 mg/5 mL* (2mg/mL), 10 x 5 mL Single-dose Vials per Carton, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Hollywood, FL 33024, Made in India, Single-doSubpotent product:out of specification assay results observed during long term stability testing.
- Class I
Medical Device Recall · November 26, 2025
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003LMedline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
- Class II
Medical Device Recall · November 25, 2025
Brand Name: Mastisol Liquid Adhesive Product Name: Liquid Adhesive Model/Catalog Number: 0523-48 Product Description: Liquid adhesive, 2/3 mL vial, 48 vials per carton Component: NoButyrate tube cracks during actuation, rendering product unusable.
- Class II
Food Recall · November 25, 2025
Prairie Farms Fat Free Milk, 1 Gallon (3.78L) plastic jug, UPC 7273023117Product may contain food-grade cleaning agents
- Unclassified
Vehicle Recall · November 25, 2025
2026 CHEVROLET SILVERADO 3500Without an owner's manual to consult, owners may not know how to safely use and operate the vehicle, increasing the risk of injury in a crash.
- Class II
Food Recall · November 25, 2025
Celebration Herbals Senna Leaf Herbal Tea 24 Teabags, net wt. 1.48oz. UPC 628240201829possible salmonella
- Unclassified
Vehicle Recall · November 25, 2025
2023 INTERNATIONAL MV, 2023 INTERNATIONAL LT, 2023 INTERNATIONAL RH, 2025 INTERNATIONAL MV, 2026 INTERNATIONAL MVSafety systems that depend on the ECU, such as Automatic Traction Control, ABS, Electronic Stability Control, Active Cruise Control, and Collison Mitigation System, may have diminished or lost functionality, increasing the risk of a crash.
- Class II
Food Recall · November 25, 2025
Imu-Tek Animal Health, Incorporated
Imu-Tek Immuno-5 Colostrum Powder 7 oz. Intended Use: Dietary Supplement for People. (Some customers use this for their pets).Packaging: Plastic jar with Sealed lid. Net Weight: 7 ounces. UPC:7Undeclared milk allergen
- Class I
Medical Device Recall · November 24, 2025
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Class II
Medical Device Recall · November 24, 2025
Zimmer Dermatome AN, Model/Catalog Number: 88710100The devices may have a misaligned thickness control bar.
- Class I
Medical Device Recall · November 24, 2025
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities.
- Class II
Medical Device Recall · November 24, 2025
BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.Removal of affected lot of screws due to labeling error.
- Class II
Medical Device Recall · November 24, 2025
LifeShield Drug Library Management (DLM); LifeShield Infusion Safety Software Suite v2.2 List Number 17003-02For certain customers, the Change Summary review option ceases to operate as expected for any migrated library after the migration has been completed. Users must use alternate methods to review changes. Failure to do so may lead in over delivery, under delivery, or delay in setup on the infusion pump.
- Class I
Medical Device Recall · November 24, 2025
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Class I
Medical Device Recall · November 24, 2025
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Class I
Medical Device Recall · November 24, 2025
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Numbers: 9903-20, 17188-04, 19762-03, 19203-04, 19203-04, 17957-10 Software Version: N/A Product Description: Alcon CuOphthalmic procedure packs may have incomplete seals affecting sterility.
- Class II
Medical Device Recall · November 24, 2025
LifeShield Drug Library Management (DLM), LifeShield Infusion Safety Software Suite v2.2 Product No. 17003-02Software issue only allows Concentration Limits to be defined to one digit of precision past the decimal point (0.1) instead of three digits (0.001). If the user is unable to use Concentration Limits as intended, they may need to change the limits to something other than what is recommended by the drug manufacturer, which may result in over- or under-delivery.
- Class II
Drug Recall · November 24, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge PharmacCGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Class I
Medical Device Recall · November 24, 2025
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.Due to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results
- Class I
Medical Device Recall · November 24, 2025
Draeger Vapor 2000. Unheated, calibrated anesthetic vaporizer.A certain component of affected devices was not delivered within specification and contained impurities.
- Class II
Drug Recall · November 24, 2025
Breckenridge Pharmaceutical, Inc.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient PharmacCGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
- Class II
Medical Device Recall · November 24, 2025
Zimmer Air Dermatome, Model/Catalog Number: 00880100100The devices may have a misaligned thickness control bar.
- Class II
Food Recall · November 24, 2025
Zen Cleanse Blend herbal tea; .95 oz (27g) pouch; 18 pouches/box UPC: 819005011504Potential Salmonella contamination
- Class II
Food Recall · November 24, 2025
Outer-packaging: gimme! brand Decaf de Agua coffee pods, Net Wt. 4.23 oz, UPC 051497457990, box of 10 pods Inner-packaging/pod packaging: gimme! coffee Deep Disco caffeinated coffee podsUndeclared caffeine
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
S. Typhi/Para Typhi A AntigenTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone TTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in cylindrical clear plastic tubs with lid UPC: 2-77580-XXXXX-7, where X is the unit price of the contProduct may be contaminated with Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Protein TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
LH One Step Ovulation Test Device (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; UriTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)Potential presence of Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Exploro Highly Sensitive Male Fertility / Sperm Concentration TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Menopause Test Cassette (Urine)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Vivoo Vaginal pH TestTest strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 22, 2025
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)Potential presence of Listeria monocytogenes.
- Class II
Medical Device Recall · November 22, 2025
Changchun Wancheng Bio-Electron Co., Ltd.
Male Fertility Sperm Test for Home Use (Cassette)Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
- Class I
Food Recall · November 21, 2025
Silvestri Sweets Inc dba Carousel Candies
Choceur Cookie Butter Holiday Bark. Standup Pouch Bag. 5 oz. (142g). UPC: 4069365095690. Wholesale unit is split case, with 9 of each item per case.Undeclared pecan
- Class I
Food Recall · November 21, 2025
Ambriola Piccante grated Pecorino Romano, 5 and 10-pound plastic bags (units)Product tested positive for Listeria Monocytogenes.
- Class III
Drug Recall · November 21, 2025
Glenmark Pharmaceuticals Inc., USA
Bisoprolol Fumarate and Hydrochlorothiazide Tablets, USP, 2.5 mg/6.25 mg, packaged as (a) 30-count bottles, NDC-68462-878-30; (b) 100-count bottle, NDC-68462-878-01; (c) 500-count bottles, NDC-68462-8Cross Contamination with Other Products: Testing of reserve samples showed presence of traces of ezetimibe
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per caseProduct tested positive for Listeria Monocytogenes.
- Class II
Medical Device Recall · November 21, 2025
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.Emphasizing instructions for LVP duration programming located in the IFU.
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)Product tested positive for Listeria Monocytogenes.
- Class I
Food Recall · November 21, 2025
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per caseProduct tested positive for Listeria Monocytogenes.
- Unclassified
Vehicle Recall · November 21, 2025
2024 HYUNDAI SANTA FE, 2025 HYUNDAI SANTA FE, 2025 HYUNDAI SANTA FE HYBRIDA rearview image that does not display reduces the driver's view behind the vehicle, increasing the risk of a crash.
- Class II
Food Recall · November 21, 2025
Lotus Mom Corporation dba Indian Kitchen Mart
Aluminum Kadai with Metal Handles Size 5. A-Cook MADE IN INDIA SIZE 5 Sticker label: $$24.99+TXPotential contamination with leachable lead.
- Class II
Food Recall · November 21, 2025
Yoyo Gummy Assorted Flavor, 2.8 Oz (80g) , Plastic Bag, 24 bags per caseThe products contain an unallowed color Carmoisine (E122) - Acid Red 14.
- Class II
Medical Device Recall · November 21, 2025
Roche Diagnostics Operations, Inc.
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreIssues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
- Class I
Food Recall · November 21, 2025
SENNA LEAVES F/C OG Item No: SEN15001 Net Wt: 44.75 Lbs Distributed By Whole Herb Company 19800 8th Street East, Sonoma, CA 95476 UPC 10031 44312Potential contamination with Salmonella.