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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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14 recalls that day

Bard Access Systems DuoGlide and Power-Trialysis Short-Term Straight Dialysis Catheter

Bard Access Systems is recalling its Power-Trialysis Short-Term Straight Dialysis Catheter because this is a downstream recall of class I recall RES 98777.

High risk, FDA, Device defect

Intercon Foaming Hand Soaps

Intercon Foaming Hand Soaps have possible bacterial contamination.

Moderate risk, FDA, Contamination

ICU Medical IV and Oncology Administration Sets

ICU Medical IV and Oncology Administration Sets may have black specks in their drip chambers.

Moderate risk, FDA, Foreign object

3 recalls that day

Evergreen Fresh Sprouts Broccoli Sprouts

Broccoli Sprouts may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Windstone Medical Packaging AMS Convenience Kit DSAEK Pack

The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags.

Moderate risk, FDA, Device defect

MedicaLyte and Citric Complete Concentrates

MedicaLyte and Citric Complete Concentrates contain high endotoxin levels.

Moderate risk, FDA, Contamination

4 recalls that day

OurPharma FentaNYL Citrate Injection Solution

FentaNYL Citrate Injection solution has a labeling discrepancy between the bag expiry and product expiry.

Moderate risk, FDA, Labeling error

International Specialty Supply Alfalfa

Alfalfa may be contaminated with E. coli and Salmonella.

High risk, FDA, Salmonella

Fannie May & XO Marshmallow Pixie S'mores Collection

The Fannie May & XO Marshmallow Pixie S'mores Collection contains undeclared milk and pecans.

Moderate risk, FDA, Undeclared milk

Medical Action Industries Epidural Kits

Epidural and pain kits containing sodium chloride ampules may have compromised sterility.

High risk, FDA, Sterility problem

6 recalls that day

Freshpoint Central Florida Cranberry Chicken Salad Wedge

The chicken salad sandwich has an improperly declared allergen (egg), which can cause serious or life-threatening allergic reaction in people with egg allergy.

Moderate risk, FDA, Undeclared egg

ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution

Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution may be weaker than labeled.

Low risk, FDA, Wrong drug strength

Ajanta Pharma Fluphenazine Hydrochloride Tablets

Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles may contain more impurities than allowed.

Low risk, FDA, Drug impurity

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced may have been exposed to unacceptable temperatures due to extended transit time.

Moderate risk, FDA, Ended, Hospital use, Processing problem

American National Red Cross PF24 Plasma and Red Blood Cells

Red blood cells and plasma were distributed after donors' arm inspections were not properly performed.

Low risk, FDA, Ended, Hospital use, Donor screening problem

Lifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The platelets did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99488

1 recall that day

Made Fresh Salads: 61 products

Made Fresh Salads foods may be contaminated with Listeria.

High risk, FDA, Listeria

11 recalls that day

Foods Alive Organic Moringa Leaf Powder

Organic moringa leaf powder may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Business Pill and Branch Manager for Men

Business Pill and Branch Manager for Men dietary supplements contain undeclared yohimbine, which can cause severe hypertension and heart problems.

Not yet rated, FDA

Crown Farms Dried Suri Cut

Crown Farms Dried Suri Cut was not properly eviscerated before drying.

High risk, FDA, Processing problem

Getinge PVC Thoracic Catheter

Getinge PVC Thoracic Catheters may contain too much bacterial endotoxin.

Moderate risk, FDA, Quality testing problem

Lutronic DermaV Laser System

Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment.

Moderate risk, FDA, Device defect

HeartSine Samaritan PAD Defibrillators SAM 350P, SAM 360P and SAM 450P

HeartSine SAM 350P, SAM 360P, and SAM 450P defibrillators have a damaged membrane tail causing an intermittent fault.

Moderate risk, FDA, Device defect

Halyard IV Start Kits

Halyard IV Start Kit Non-Sterile lacks sterility assurance due to wrinkles in the paper lidding that may breach the seal area.

Moderate risk, FDA, Sterility problem

Bard Foley Catheter Trays and Intermittent Catheter Trays

Products that contain the Pericare Wipes may have contamination on the surface.

Moderate risk, FDA, Contamination

Stanford Blood Center Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex

Red Blood Cells and Pathogen Reduced Cryoprecipitated Fibrinogen Complex were collected with potential air contamination.

Moderate risk, FDA, Ended, Hospital use, Contamination

LifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced

The product did not meet platelet yield specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem, FDA event number 99487

Medic Apheresis Platelets and Platelets Extended Dating

Apheresis Platelets, Leukocytes Reduced, Irradiated, with a platelet count higher than was acceptable, were distributed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

6 recalls that day

American Regent Epinephrine Injection

Presence of Particluate Matter and Lack of Assurance of Sterility.

High risk, FDA, Sterility problem

Fi Daily Supplement Powders

Fi Daily Supplement Powders may be contaminated with Salmonella, which can affect animals and potentially humans.

High risk, FDA, Salmonella

Trokendi XR (Topiramate) Extended-Release Capsules

Trokendi XR, (topiramate) extended-release capsules may not dissolve properly in the body.

Low risk, FDA, Drug dissolving problem

Mylan Mycophenolate Mofetil for Injection

Mylan Institutional LLC Mycophenolate Mofetil for injection, USP, 500 mg/vial may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Cardinal Health 200 Presource Packs Containing CliniClean Pericare Wipes Within BD Urinary Catheter Trays

Presource Packs with CliniClean Pericare Wipes in BD Urinary Catheter Trays may be contaminated with a lubricant, causing skin irritation.

Moderate risk, FDA, Contamination

Fresenius Medical Care Acid Concentrates

Fresenius Medical Care Renal Therapies Group is recalling its Granuflo Dry Acid Concentrate because of complaints of blue-green discoloration in product.

Moderate risk, FDA, Device defect

7 recalls that day

Teva Trazodone Hydrochloride Tablets

TraZODone Hydrochloride Tablets contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Fresenius Medical Care 5008X Blood Tubing Sets

Blood tubing sets may leak at the connection between the Arterial Alpha Clip and the main line, causing blood loss and hypovolemia.

Moderate risk, FDA, Device defect

B Braun Medical Discofix Four Way Stopcock Extension Sets

The Discofix Four Way Stopcock has an incorrect expiration date printed on the carton shipper label.

Moderate risk, FDA, Labeling error

LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System

The LUX-Dx Insertable Cardiac Monitor System may delay AF Burden Alert notification, potentially delaying clinical evaluation or therapeutic intervention.

Moderate risk, FDA, Software defect

Wonton Specialist Noodles and Skins

Pan Fried Noodle, Wonton Noodle, Lo Mein Noodle, Wonton Skin, Dumpling Skin, and Cooked Noodle contain undeclared FD&C Red No. 40.

Low risk, FDA, Undeclared color or additive

Medos International Velys Enabling Tech Robotic-Assist Station

The Velys Enabling Tech Robotic-Assist Station has a software issue that may cause unintended movement of the robotic arm.

Moderate risk, FDA, Software defect

Vitalant Pooled Cryoprecipitated AHF

Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

3 recalls that day

Philips Brilliance, IQon Spectral and Ingenuity CT Scanners

Philips CT systems have an unintended radiation issue that could affect equipment performance.

Moderate risk, FDA, Device defect

Broadway Joe's Pain Cream

Broadway Joe's Pain Cream may be contaminated due to raw material contamination.

Moderate risk, FDA, Contamination

Sage Chlorhexidine Gluconate Cloths

2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths can cause cross contamination with other products.

Moderate risk, FDA, Contamination

10 recalls that day

Crystal Temptations Little Temptations Chocolatey Eyeballs Spooks and Spells

Chocolatey Eyeballs contain undeclared milk allergens, posing a risk of serious allergic reaction.

Moderate risk, FDA, Labeling error

Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil

Kofinas Garlic Mediterranean Infused Extra Virgin Olive Oil contains garlic essential oil not approved for culinary use.

Moderate risk, FDA, Unapproved product

Lipofit Extreme Fat Burner 2.0

Lipofit Extreme Fat Burner 2.0 contains undeclared fluoxetine and DNP, which can cause serious and life-threatening effects.

Not yet rated, FDA

American Health Packaging Buprenorphine Sublingual Tablets

Buprenorphine Sublingual Tablets have a label mix-up.

Low risk, FDA, Labeling error

Medline Convenience Kits with BD ChloraPrep Applicators

Medline Convenience Kits containing BD ChloraPrep Clear Applicators may have an open or incomplete seal, which could lead to infection.

Moderate risk, FDA, Contamination

Baxter Novum IQ Syringe Pump

The syringe pump has a software issue that may occur during multi-syringe infusion.

Moderate risk, FDA, Software defect