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FDA recalls

Food, drug, biologic, medical device and cosmetic recalls from the FDA, newest first. 1,957 recalls Each recall is dated by the day its recall page names (how recalls are dated).
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8 recalls that day

Endo USA Buprenorphine Hydrochloride Injection

Buprenorphine Hydrochloride Injection contains particulate matter identified as Buprenorphine free base.

Moderate risk, FDA, Foreign object

Technological Medical Advancements Diowave Laser System

The Diowave Laser System needs a software update because it operates at a maximum average power output of 70W, beyond the FDA cleared 60W.

Moderate risk, FDA, Software defect

Jolife LUCAS Chest Compression System

LUCAS chest compression systems may have service records that do not justify passing results.

Moderate risk, FDA, Device defect

Better Weather Fix Elixir Dietary Supplements

Better Weather Fix Elixir dietary supplements contain undeclared Kratom, which can cause nausea, vomiting, and rapid heart rate.

Not yet rated, FDA

8 recalls that day

MG217 Multi-Symptom Treatment Cream & Skin Protectant

MG217 Multi-Symptom Treatment Cream is contaminated with Staphylococcus aureus and could cause infections.

High risk, FDA, Contamination

Oasis Tears PF Preservative-Free Lubricant Eye Drops

Oasis Tears PF lubricant eye drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Dakota Honey Company Honey Flight and Spreadable Spun Honey

Dakota Honey Company Honey Flight and Spreadable Spun Honey contain foreign object (stainless steel dust/flakes or shreds of plastic).

Moderate risk, FDA, Foreign object

GE HealthCare Revolution CT Scanners

GE HealthCare has identified a potential security vulnerability in certain Revolution CT systems.

Moderate risk, FDA, Software defect

Namic Manifolds and Kits

Medline has identified the presence of particulate within the fluid path of the Manifolds.

High risk, FDA, Foreign object

Alain Milliat Marmelade Orange

The Alain Milliat Marmelade Orange may contain foreign objects, specifically glass.

Moderate risk, FDA, Ended, Foreign object

Donjoy IceMan CLASSIC3 Cold Therapy Unit

Donjoy IceMan CLASSIC3 cold therapy unit have a broken connector that may interrupt prescribed cold therapy.

Moderate risk, FDA, Device defect

On-X Mitral Heart Valve with Conform-X Sewing Ring

The On-X Mitral Heart Valve with Conform-X Sewing Ring was released before all required testing was complete.

Moderate risk, FDA, Device defect

9 recalls that day

Stoltzfus Family Farm Sour Cream and Onion Cheese Curds

Sour Cream and Onion cheese curds may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Fireworks Popcorn White Cheddar Seasoning

White Cheddar Seasoning may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Legacy Bakehouse Bagel Crisps and Pita Chips

Legacy Bakehouse Bagel Crisps and Pita Chips may be contaminated with Salmonella.

High risk, FDA, Salmonella

George J Howe Sunflower Seeds

Sunflower Seeds may contain undeclared cashew, posing a risk of serious or life-threatening allergic reaction.

High risk, FDA, Ended, Undeclared tree nut

Cafe Nouria Blueberry Muffin

The blueberry muffin contains undeclared walnuts, which can cause serious allergic reactions in people with tree nut allergies.

Moderate risk, FDA, Undeclared tree nut

Lundberg Family Farms Jasmine White Rice

Lundberg Family Farms white rice jasmine may be contaminated with foreign materials.

Moderate risk, FDA, Ended, Contamination

BioCera Fibers and ZENBONE

Orthorebirth is recalling its Zenbone and BioCera Fibers because of Resorbable bone void filler falls outside standard specifications.

Moderate risk, FDA, Device defect

Medline Convenience Kits, Surgical Drapes, Gowns and Packs

Medline identified issues related to calibration of the equipment used to sterilize and package the devices.

Moderate risk, FDA, Sterility problem

Central Admixture Pharmacy Services TPN Bags

The TPN bag did not contain insulin as listed on the label.

Moderate risk, FDA, Labeling error

14 recalls that day

JCB Flavors Seasonings and Popcorn Toppings

JCB Flavors Seasonings and Popcorn Toppings may be contaminated with Salmonella.

High risk, FDA, Salmonella

Albright's All Natural Raw Pet Food Chicken Recipe for Dogs

Albright's All Natural Raw Pet Food Chicken Recipe for Dogs may be contaminated with Salmonella, which can cause illness in pets and people.

High risk, FDA, Ended, Salmonella

Good & Gather Sesame Teriyaki Chicken with Rice

Sesame Teriyaki Chicken with Rice has undeclared sesame and soy allergens.

Moderate risk, FDA, Ended, Undeclared soy

Givaudan Flavors Seasoning for Cheese Sauce

Bulk seasoning for cheese sauce may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Breckenridge Pharmaceutical Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the recommended limit.

Moderate risk, FDA, Drug impurity

Publix Bran Flakes, Wheat Cereal

Publix Bran Flakes, Wheat Cereal contains foreign material (plastic).

Moderate risk, FDA, Ended, Foreign object

Acella Naproxen Oral Suspension

The product is chemically contaminated with lead and lithium above specification.

Moderate risk, FDA, Chemical contamination

BioFire Joint Infection (JI) Panel

The BioFire Joint Infection Panel may be contaminated, causing false positives.

Moderate risk, FDA, Contamination

Mint Lesion

Mint Lesion can lose or incorrectly link information when its connection is interrupted during a read.

Moderate risk, FDA, Device defect

DFI One Step and QUCARE In Vitro Diagnostic Tests

The devices were distributed without required FDA premarket clearance or approval.

Moderate risk, FDA, Unapproved product

Medline Namic Angiographic Control Syringes Convenience Kits

Convenience kits containing syringes with a rotating adaptor may unwind during use, causing loose or full disconnection.

High risk, FDA, Device defect

Biofire Spotfire Respiratory/Sore Throat Panel

The Biofire Spotfire Respiratory/Sore Throat Panel may result in false negative results and control failures.

Moderate risk, FDA, Device defect

Medical Action Industries Pack Cath BHH

Pack Cath BHH contains a syringe whose rotating adapter may unwind, causing loose or full disconnection.

High risk, FDA, Device defect

DEX Ophthalmic Tissue Forceps

DEX Ophthalmic Tissue Forceps have a Field Safety Corrective Action for their instructions for use.

Moderate risk, FDA, Device defect

16 recalls that day

My Wife's Slaw

My Wife's Slaw was made without an approved inspection, so its safety could not be verified.

Moderate risk, FDA, Ended, Produced without inspection

Market of Choice Vegan Kale Caesar Salad

Market of Choice Vegan Kale Caesar Salad contains undeclared sesame, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared sesame

MA Cohen's Kippered Herring

MA Cohen's Kippered Herring may be contaminated with C. botulinum (botulism), which can cause life-threatening illness or death.

High risk, FDA, Ended, Botulism

Southern Style Nuts, Squirrel Brand, Good & Gather and Fisher Trail Mixes

John B Sanfilippo & Sons mixes may contain Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Winfield's CWB Chocolate Bar

Winfield's CWB Chocolate Bar has undeclared milk allergen, which can cause serious or life-threatening allergic reactions.

Moderate risk, FDA, Undeclared milk

Covetrus and VetOne Amoxicillin and Clavulanate Potassium Oral Suspension Drops for Dogs and Cats

This voluntary recall is due to market complaints pertaining to product discoloration following reconstitution.

Moderate risk, FDA, Quality problem

Woodstock Organic Shelled Edamame

Woodstock Organic Shelled Edamame contains metal pieces.

Moderate risk, FDA, Ended, Foreign object

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies.

Moderate risk, FDA, Sterility problem

California Dairies Non-Fat Dried Milk and Buttermilk Powders

Low Heat Non-Fat Dried Milk Powder and Buttermilk Powder may be contaminated with Salmonella.

High risk, FDA, Salmonella

Rising Pharma Enalapril Maleate Tablets

Enalapril Maleate Tablets, USP, 20 mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

BD PurPrep Povidone-Iodine and Isopropyl Alcohol Antiseptic Solution

BD PurPrep sterile solution may lack sterility assurance due to potential contamination.

Moderate risk, FDA, Sterility problem

Walker Honey Creamed and Whipped Honey Spreads

Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.

Moderate risk, FDA, Foreign object

Horizon Organic Chocolate Organic Lowfat Milk

Horizon Organic Chocolate Organic Lowfat Milk has compromised package integrity.

Moderate risk, FDA, Ended, Packaging defect

ALBA Bioscience ALBAzyme Papain Solution Kit

ALBAzyme Papain Solution Kit may have reduced activity, causing incomplete removal of enzyme-sensitive antigens from red blood cells.

Low risk, FDA, Ended, Device defect

ALBA Bioscience Ortho Sera Papain

ORTHO Sera Papain has reduced reactivity, which may cause hemolytic transfusion reactions.

Low risk, FDA, Ended, Device defect