FDA recalls
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.
2 productsIntercon Foaming Hand Soaps
Intercon Foaming Hand Soaps have possible bacterial contamination.
6 productsICU Medical IV and Oncology Administration Sets
ICU Medical IV and Oncology Administration Sets may have black specks in their drip chambers.
8 productsEvergreen Fresh Sprouts Broccoli Sprouts
Broccoli Sprouts may be contaminated with Salmonella, which can cause serious infections.
Windstone Medical Packaging AMS Convenience Kit DSAEK Pack
The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags.
MedicaLyte and Citric Complete Concentrates
MedicaLyte and Citric Complete Concentrates contain high endotoxin levels.
4 productsOurPharma FentaNYL Citrate Injection Solution
FentaNYL Citrate Injection solution has a labeling discrepancy between the bag expiry and product expiry.
International Specialty Supply Alfalfa
Alfalfa may be contaminated with E. coli and Salmonella.
Fannie May & XO Marshmallow Pixie S'mores Collection
The Fannie May & XO Marshmallow Pixie S'mores Collection contains undeclared milk and pecans.
Medical Action Industries Epidural Kits
Epidural and pain kits containing sodium chloride ampules may have compromised sterility.
2 productsFreshpoint 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.
ImprimisRx NJ Povidone Iodine and Proparacaine Ophthalmic Solution
Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution may be weaker than labeled.
Ajanta Pharma Fluphenazine Hydrochloride Tablets
Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles may contain more impurities than allowed.
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.
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.
3 productsLifesouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
The platelets did not meet platelet yield specifications.
Foods Alive Organic Moringa Leaf Powder
Organic moringa leaf powder may be contaminated with Salmonella, which can cause serious infections.
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.
Crown Farms Dried Suri Cut
Crown Farms Dried Suri Cut was not properly eviscerated before drying.
Getinge PVC Thoracic Catheter
Getinge PVC Thoracic Catheters may contain too much bacterial endotoxin.
3 productsLutronic DermaV Laser System
Utilizing higher fluences at 1064nm wavelength with current cryogen parameters may result in a spark/loud noise during treatment.
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.
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.
Bard Foley Catheter Trays and Intermittent Catheter Trays
Products that contain the Pericare Wipes may have contamination on the surface.
6 productsStanford 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.
2 productsLifeSouth Community Blood Centers Apheresis Platelets, Leukocytes Reduced, Pathogen Reduced
The product did not meet platelet yield specifications.
Medic Apheresis Platelets and Platelets Extended Dating
Apheresis Platelets, Leukocytes Reduced, Irradiated, with a platelet count higher than was acceptable, were distributed.
3 productsAmerican Regent Epinephrine Injection
Presence of Particluate Matter and Lack of Assurance of Sterility.
Fi Daily Supplement Powders
Fi Daily Supplement Powders may be contaminated with Salmonella, which can affect animals and potentially humans.
2 productsTrokendi XR (Topiramate) Extended-Release Capsules
Trokendi XR, (topiramate) extended-release capsules may not dissolve properly in the body.
Mylan Mycophenolate Mofetil for Injection
Mylan Institutional LLC Mycophenolate Mofetil for injection, USP, 500 mg/vial may not dissolve properly in the body.
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.
12 productsFresenius 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.
3 productsTeva Trazodone Hydrochloride Tablets
TraZODone Hydrochloride Tablets contain foreign tablets or capsules.
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.
4 productsB Braun Medical Discofix Four Way Stopcock Extension Sets
The Discofix Four Way Stopcock has an incorrect expiration date printed on the carton shipper label.
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.
3 productsWonton 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.
6 productsMedos 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.
Vitalant Pooled Cryoprecipitated AHF
Pooled Cryoprecipitated AHF was not prepared in accordance with specifications.
Philips Brilliance, IQon Spectral and Ingenuity CT Scanners
Philips CT systems have an unintended radiation issue that could affect equipment performance.
4 productsBroadway Joe's Pain Cream
Broadway Joe's Pain Cream may be contaminated due to raw material contamination.
2 productsSage Chlorhexidine Gluconate Cloths
2% Chlorhexidine Gluconate Cloth, Non-sterile, 6 Disposable cloths can cause cross contamination with other products.
Crystal Temptations Little Temptations Chocolatey Eyeballs Spooks and Spells
Chocolatey Eyeballs contain undeclared milk allergens, posing a risk of serious allergic reaction.
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.
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.
American Health Packaging Buprenorphine Sublingual Tablets
Buprenorphine Sublingual Tablets have a label mix-up.
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.
13 productsBaxter Novum IQ Syringe Pump
The syringe pump has a software issue that may occur during multi-syringe infusion.
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