Safety Recalls
RSS ↗15,362 recalls across FDA food, drug, and medical device recalls, CPSC consumer products, and NHTSA vehicles.
Showing 9,251–9,300 of 15,362
- Class II
Drug Recall · November 14, 2024
Henry Schein, Benzo-Jel, Topical Anesthetic Gel, 20% Benzocaine, 1 fl. oz. (29.6 mL), Distributed by Henry Schein, Melville, NY 11747, For Professional Use Only,CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
Burkhart, Topical Anesthetic Gel, Benzocaine 20%, Gluten Free, 1 FL. OZ (30 ml), Manufactured for Burkhart Dental Supply, Tacoma, Washington 98409.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
Patterson Dental, Patterson Topical Anesthetic Gel, Benzocaiine, 1 oz. (30 ml), Manufactured for (Fabrique pour): Patterson Dental Supply, Inc. 1031 Mendota Heights Road, Saint Paul, MN 55120, NDC 502CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets blister pack; (Acetaminophen 325mg, Dextromethorphan HBr 10 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg); Night - 56 coated caplCGMP Deviations: Released product should have been rejected.
- Class I
Medical Device Recall · November 14, 2024
Accutome/Microsurgical Disposable Bipolar Pencil 5 in. (12.7cm) 25 Gauge Straight. Model/Catalog Number: AB-7004 The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, andPotential for the outer stainless-steel tube to break or detach.
- Class II
Drug Recall · November 14, 2024
Pearson Quality, Topical Anesthetic Gel, 20% Benzocaine, For Professional Use Only, Net Contents: 1 oz (30 g), Manufactured for Pearson Dental Supply Inc., Sylmar, CA 91342 USA.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Class II
Drug Recall · November 14, 2024
Ipana, 20% Benzocaine Topical Gel, 28g, Maxill Inc., St Thomas ON Canada.CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
- Unclassified
Consumer Product Recall · November 14, 2024
Celebration Girl's Summer Pajama SetsThe recalled children's pajamas violate the flammability regulations for children's sleepwear, posing a risk of burn injuries to children.
- Class I
Food Recall · November 14, 2024
Simple Truth Organic, BROCCOLI FLORETS, STEAM IN BAG, 12oz, BEST IF USED BY NOV 08 2024, PRODUCT OF MEXICOPotential contamination with Listeria monocytogenes.
- Class II
Food Recall · November 14, 2024
Rise Baking Company, LLC dba The New French Bakery Inc.
L'Oven Fresh KETO Friendly Original 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271348. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of CanadaForeign Material (metal)
- Class II
Food Recall · November 14, 2024
Rise Baking Company, LLC dba The New French Bakery Inc.
Bakestone Brothers Pita Bread, 6 Whole Wheat Pitas. Net Wt. 11.4 oz(325g) UPC 0 57391-01002 6. Manufactured by PBF pita Bread Factory Ltd, 8000 Winston Street, Burnaby British Columbia V5A 2H5.Foreign Material (metal)
- Class II
Food Recall · November 14, 2024
Rise Baking Company, LLC dba The New French Bakery Inc.
Bakestone Brothers Pita Bread, 6 White Pita. Net Wt. 11.4 oz(325g) UPC 0 57391-00001 0. Manufactured by PBF pita Bread Factory Ltd, 8000 Winston Street, Burnaby British Columbia V5A 2H5. ProductForeign Material (metal)
- Class II
Food Recall · November 14, 2024
Rise Baking Company, LLC dba The New French Bakery Inc.
L'Oven Fresh KETO Friendly Multiseed 6 Tortilla Wraps. Net Wt. 7.8 oz(222g) UPC 4099100271355. Dist & Sold Exclusively By: Aldi, Batavia, IL 60510. Product of CanadaForeign Material (metal)
- Class I
Medical Device Recall · November 14, 2024
Kirwan Surgical Products LLC Disposable 25-gauge bipolar pencil, straight, Long. Model/Catalog Number: 14-5011L The Disposable Microsurgical Bipolar Pencil are designed for use in eye surgery, andPotential for the outer stainless-steel tube to break or detach.
- Class II
Medical Device Recall · November 14, 2024
BD Pyxis MedStation ES, REF: 323Due to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and incorrect medication removal, or 2) Potential for a different medication (medication pulled in error) to be refilled/loaded, which may lead to may lead to low inventory or a stockout.
- Unclassified
Consumer Product Recall · November 14, 2024
New Cosmos USA Inc., of Lisle, Illinois
DeNova Detect Brand Combination Natural Gas and Carbon Monoxide AlarmsAfter alerting consumers to the presence of natural gas or carbon monoxide, the recalled alarm can go into sleep mode when the alert lasts less than four minutes. During this time, the alarms can fail to detect and alert consumers to a new incidence of natural gas or carbon monoxide, posing a risk of carbon monoxide poisoning.
- Unclassified
Consumer Product Recall · November 14, 2024
woom Bike USA LLC, of Austin, Texas
woom bicycles OFF 5, OFF AIR 5, OFF 6, OFF AIR 6, and ORIGINAL 6The crank can break, due to fatigue fractures, causing the rider to lose control, posing fall and crash hazards.
- Unclassified
Consumer Product Recall · November 14, 2024
UFP Saginaw LLC, dba Outdoor Essentials, of Saginaw, Texas
Cultivar Planter BoxesThe recalled planter box frame can break, posing an injury hazard.
- Class II
Medical Device Recall · November 13, 2024
Brand Name: Alcon Product Name: Monarch¿ III D Delivery Cartridge Model/Catalog Number: 8065977763 Product Description: Monarch¿ III D delivery cartridge Lens Guide, Intraocular Component: N/AIncrease in complaints associated with a molding defect within the inner lumen of delivery cartridges which could result in a scratch on the intraocular lens (IOL) upon delivery.
- Class II
Food Recall · November 13, 2024
Stuyvers Bread (Premium Brand Bakery Division)
Baguette, Artisan Multigrain. (30 Units/box) 400g/each. Contains: Wheat, Sesame Seeds, Gluten (rye, barley, oat) Lot#24313Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
- Class II
Food Recall · November 13, 2024
Stuyvers Bread (Premium Brand Bakery Division)
Pull apart Holiday Rolls (cluster bun). (2 Units/bag) 195g/each. Contains: Wheat, Milk Lot#24312Possible contamination by a foreign object (metal) in sub-ingredient in dinner roll product
- Class II
Drug Recall · November 13, 2024
Brands International Corporation
Kissable Diabetics Foot Cream, NET WT 4 oz (113 g) per tube, Manufactured By: Brands International Corp., Newmarket, ON, L3X 2S2. UPC 6 72008 80925 3CGMP Deviations: lack of adequate release testing.
- Class II
Medical Device Recall · November 13, 2024
DxI 9000 Access Immunoassay Analyzer, Catalog Number C11137The DxI 9000 Access Immunoassay Analyzer wash wheel mixer may not spin freely within the idler pulley housing. When the problem occurs, the analyzer may generate a system event for a Wash Wheel Dispense Arm Spin Mixer Error that is displayed on the navigation bar in the User Interface. The analyzer enters the red system status and will generate a SYS flag. The tests that are in progress may be cancelled and may cause a delay in reporting patient results
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
STERILE STRT KELLY HEMOSTAT (SK8039S), Medline Item No. 66695Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Medical Device Recall · November 12, 2024
Aerin Medical VivAer Stylus, REF CAT1785 (individual stylus), and REF CAT500 (5-pack), sterile.Some units in a single production lot were programmed incorrectly which will result in the VivAer Stylus being incorrectly recognized as RhinAer Stylus when connected to the Aerin Console.
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
STERILE MAGILL FORCEP (MAGF9), Medline Item No. 66790Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class I
Food Recall · November 12, 2024
Gilster-Mary Lee Corporation Cake Plant
Bowl & Basket onion soup and dip mix, net wt 2 oz (2-1oz pouches), UPC 041190083947, Distributed by: Wakefern Food Corp, 5000 Riverside Drive, Keasbey, NJ 08832Undeclared egg
- Class II
Medical Device Recall · November 12, 2024
Siemens Healthcare Diagnostics, Inc.
Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 10445158;Siemens Healthcare Diagnostics is recalling two lots of their Dimension Vista¿ Total Magnesium (MG) Flex Reagent Cartridges (lots 24057BB and 24064BC) due to the potential for falsely low measurements of magnesium in plasma. Because the error is intermittent, existing quality control procedures may not recognize that a patients results are incorrect, and the results may be reported out
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST IUD REMOVAL HOOK 10" (504090), Medline Item No. I68785Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST OR MAYO HEGAR NEEDLEHOLDER 6"(OR2500), Medline Item No. 67870Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
ST REPROCESSED BRUNS CURETTE #00 (BC00), Medline Item No. 67600KWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
O.R. SCISSORS, S/B, 5.5 STERILE, Medline Item No. DYND04000Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Medical Device Recall · November 12, 2024
MEDLINE INDUSTRIES, LP - Northfield
RUMMELL, Medline Item No. ST006STWeak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.
- Class II
Drug Recall · November 11, 2024
Docusate Sodium 250 mg, 1 Softgel in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-101-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Class II
Drug Recall · November 11, 2024
Venofer (iron sucrose) Injection, USP 50 mg Elemental Iron per 2.5 mL (20 mg/mL), 2.5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02Presence of Particulate Matter: Potential for glass delamination from the vials.
- Class II
Medical Device Recall · November 11, 2024
TriALTIS TORQUE LIMITER, RATCHET, 11.3 Nm, Model Number 5161-00-5048 (G919509)An out of specification component may result in the device exhibiting torque output higher than the design specification.
- Class II
Drug Recall · November 11, 2024
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Class II
Drug Recall · November 11, 2024
Aspirin Chewable tablet 81 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-129-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Class II
Drug Recall · November 11, 2024
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, American Regent, Inc. Shirley, NY 11967, NDC: 0517-2340-01 (Presence of Particulate Matter: Potential for glass delamination from the vials.
- Class II
Drug Recall · November 11, 2024
Venofer (iron sucrose) Injection, USP 100 mg Elemental Iron per 5 mL (20 mg/mL), 5 mL Single-Dose Vials, Rx Only, For Intravenous Use Only, Distributed by: Fresenius Medical Care NA, Waltham, MA 02451Presence of Particulate Matter: Potential for glass delamination from the vials.
- Class II
Drug Recall · November 11, 2024
Vitamin B1, 100 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-108-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Class II
Drug Recall · November 11, 2024
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
- Class II
Medical Device Recall · November 11, 2024
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Allura Xper Systems (R7.6-R8.1). Labeled as the following: 1. Allura Xper FD10, Model Number: 722010. 2. Allura Xper FD10/10, Model Number: 722011. 3. Allura Xper FD20, Model Number:Potential safety issues in Allura Xper R7.6- R8.1 systems where the Lifetime Extension (LTE) kit is not installed in a timely manner. Root cause is under investigation, but the recall reason is listed as for systems over 10 years of life with LTE kits are experiencing propeller motor clamping bolt and x-ray tube locking bolt breaks. If this happens, it may cause erratic C-arm movements and potential collision with patients or bystanders, or detection of a false collisions and subsequent blocked movement of the c-arm. Movement may also cause image noise and black area on the x-ray image, and possible need to expose the patient to additional unnecessary radiation during re-examination.
- Class II
Food Recall · November 11, 2024
Giant Eagle churned Butter Pecan Reduced Fat 48FLOZ, UPC 030034940430; 6 retail units per caseUndeclared soy (soy lecithin).
- Unclassified
- Unclassified
Vehicle Recall · November 9, 2024
2024 WINNEBAGO EKKO, 2025 WINNEBAGO VIEW, 2025 WINNEBAGO EKKOAn air conditioner soft start device that overheats increases the risk of a fire.
- Unclassified
Vehicle Recall · November 9, 2024
2023 TIFFIN ALLEGRO BAY, 2024 TIFFIN ALLEGRO BAYElectrical arcing increases the risk of a fire.
- Class II
Medical Device Recall · November 8, 2024
O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the packaging, compliance is required.
- Class II
Medical Device Recall · November 8, 2024
Cardinal Health Presource Kits: 1) ACDF PACK, Catalog Number: SNEHBACSCA; 2) ACDF PACK, Catalog Number: SNEHBACSCBPotential for endotoxin contamination in non-sterile surgical strips and patties in Presource Kits.