FDA recalls
First Street and Treasured Harvest Chilli Spanish Peanuts
Chilli Spanish Peanuts may contain glass found inside a sealed container.
2 productsSunflour Bakery Hamburger Bun
Sunflour Bakery Hamburger Buns contain an undeclared sesame seed ingredient.
International Isotopes Gelatin Capsule Pack for Sodium Iodide I-131 Kit
The Gelatin Capsule Pack for the Sodium Iodide I-131 Kit failed capsule specifications.
I.T.S. Orthopedic Plates and Screws
I.T.S. Orthopedic Plates and Screws may cause higher RF-induced temperature increases under certain MRI conditions.
17 productsErbe Flexible Cryoprobes
Erbe is recalling its Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath and Flexible Cryoprobe because Probes may rupture/burst during activation.
3 productsOlympus Endoscope Valves and Reprocessors
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
4 productsGE Medical Systems Imactis CT-Navigation Systems
The Imactis CT-Navigation System can lead to discordance between simulated and actual needle trajectory.
Herbal Creations USA Colostrum Powder
Bulk packaged Colustrum Powder does not declare Milk as an allergen ingredient.
Beckman Coulter MicroScan Neg MIC 56 Panels
MicroScan Neg MIC 56 panels may be contaminated in some wells.
Somerset Therapeutics Dexamethasone Sodium Phosphate Injection
The injection failed impurity specifications during stability testing at expiry.
Datascope Battery Charging Station
The Battery Charging Station has a protruding screw that limits battery insertion and prevents proper charging.
Leksell Gamma Knife
Due to adapter not being properly aligned or locked in place.
Artegraft Vascular Graft
The Artegraft Vascular Graft has a labeling mix-up resulting in incorrect lot outer packaging.
ConvaTec EsteemBody Drainable Pouches
Convatec EsteemBody Drainable Pouch may leak due to a manufacturing issue.
3 productsAptima HPV Assay
The Aptima HPV Assay may generate invalid or false negative results.
Stryker Cub Pediatric Crib
The Cub Pediatric Crib is missing two access door warning labels.
STA Liatest D-Di
After receiving customer complaints, investigations confirmed the presence of a positive bias in D-Dimer measurements throughout the entire analytical range.
Norbrook Noromycin 300 LA Oxytetracycline Injection
Noromycin 300 LA antibiotic lacks assurance of sterility.
Greenway Farms of Georgia Garlic and Jalapeno Dill Pickles Chips
Greenway Farms of Georgia Garlic and Jalapeno Dill Pickles Chips have no process authority.
2 productsDreamland's Zaatar Chickpea Salad
Dreamland's Zaatar Chickpea Salad has undeclared sesame, soy, and wheat.
MID EAST Jordanian Zaatar Spice Mix
The MID East Jordanian Zaatar spice mix contains undeclared sesame and wheat.
ASUKAR FOODS TETAS Mireya Cherry Milkshake Popsicle
Cherry Milkshake popsicles contain undeclared soy lecithin, an allergen.
Howmedica Osteonics MICS3 Angled Sagittal Saw Attachment
The MICS3 Angled Sagittal Saw Attachment has screws that may loosen and detach during use.
Welch Allyn Spot Vision Screener VS100
The Welch Allyn Spot Vision Screener VS100 may flicker on its display screen, potentially inducing photosensitive seizures in susceptible people.
Distribuidora de Alimentos Sendero Gorditas de Azucar and Doraditas de Azucar
Gorditas de Azucar and Doraditas de Azucar are missing wheat and soy from their label, which can cause serious allergic reactions.
2 productsBluegrass Ingredients: Butter-Rich Powder and Butter Powder
Butter-Rich Powder is potentially contaminated with Salmonella, and Butter Powder is contaminated with Salmonella.
2 productsPurina Nature's Match Sow & Pig Complete Feed
Purina Nature's Match Sow & Pig Complete Feed contains Deoxynivalenol (DON) at 2.1 ppm.
Simply Nature Spinach Bites
Simply Nature Spinach Bites may be contaminated with rodent hair.
Apotex Brimonidine Tartrate and Timolol Maleate Ophthalmic Solution
Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution lacks assurance of sterility.
Taro Children's Ibuprofen Oral Suspension
Children's Ibuprofen Oral Suspension contains a gel-like mass and black particles.
Cardinal Health Webcol Alcohol Prep Pads
Webcol Alcohol Prep pads may be non-sterile due to microbial contamination, posing an infection risk to vulnerable groups.
Northstar Rx Pitavastatin Tablets
Pitavastatin Tablets, 2 mg contain a foreign tablet of 1 mg Pitavastatin.
Centricity Universal Viewer Software
Centricity Universal Viewer Software has a cybersecurity vulnerability that may expose user login credentials.
3 productsPure Vitamins and Natural Supplements Male Enhancement Supplements
Boner Bears Honey contains undeclared sildenafil and tadalafil, while Red Bull Extreme and Blue Bull Extreme contain undeclared sildenafil.
3 productsAbbott Diagnostics Scarborough ID NOW Influenza A & B 2
The ID Now Influenza A & B 2 has a higher occurrence of invalid rates.
Winder Laboratories Multivitamin with Fluoride Chewable Tablets
Multivitamin with Fluoride Chewable Tablets Grape Flavor may be weaker than labeled.
Favorina Chocolate Ladybugs German-Style Nougat
Favorina Chocolate Ladybugs German-Style Nougat may contain undeclared hazelnuts, posing a risk of serious allergic reactions.
Insulet Omnipod 5 Pods
Omnipod 5 Pods have a manufacturing defect that can cause insulin to leak inside, leading to under-delivery or cessation of insulin.
Zydus Pharmaceuticals Icosapent Ethyl Capsules
Icosapent Ethyl Capsules have red dots inside and melted capsules due to oxidized active ingredient.
Medline Open Heart, Cardiac Procedure and Cardio Congenito Kits
The instructions for use on specified Chest Drainage Units were updated to clarify the intended target patient population as adults.
Medline Medcrest Surgical Gowns and Surgical Drapes
Medline Medcrest Surgical Gowns and Medline Surgical Drapes may delaminate, causing brief delays in patient care and risk of infection.
2 productsLutronic CLARITY II Laser System
The Clarity II Laser System can spark or pop and potentially burn patients.
Altruan Strep A At-Home Self-Tests
Altruan Strep A At-Home Self-Tests are not cleared by the FDA.
3 productsHouse of Flavors Chicago Vanilla Ice Cream
House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream contains undeclared egg.
China Noodle Co. Steam Noodles and Fresh Noodles
Zhong Hua Chao Mian Noodle contains undeclared wheat and Yellow #6, and Steam Noodles contains undeclared wheat.
2 productsCoco's Italian Market Fettuccini Alfredo and Cannoli Kit
Coco's Italian Market Heat-n-Eat Fettuccini Alfredo does not declare wheat; the Cannoli Making Kit does not declare wheat or milk.
2 productsInternational Life Sciences Artelon FlexBand Dynamic Matrix and FlexBand Plus
Artelon FlexBand devices failed bacterial endotoxin testing.
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