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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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19 recalls that day

Halyard Medical Trays

Halyard Medical Trays may have quality and sterility issues.

High risk, FDA, Sterility problem

Buckhead Tuna

Buckhead Tuna may contain high levels of scombrotoxin.

Moderate risk, FDA, Chemical contamination

Captus 4000e Thyroid Uptake System

The Captus 4000e Thyroid Uptake System has a potential failure of the tension bolt, allowing the spring arm to fall unexpectedly.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The purge flag component of the purge pressure sensor assembly can fail, leading to purge cassette recognition issues.

High risk, FDA, Device defect

Medline Convenience Kits for Anesthesia, Minor Procedures, Myringotomy and Cataract Surgery

Convenience kits may have open seals in sterile pouch packaging, which can compromise sterility and lead to contamination or patient infection.

Moderate risk, FDA, Sterility problem

Datex-Ohmeda Aisys Anesthesia Systems

Anesthesia systems can automatically transition to Alternate O2 control, interrupting anesthetic agent delivery and requiring clinician intervention.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Ethicon XCEL Bladeless Trocars

Reusable access port system may crack or seperate during use.

Moderate risk, FDA, Device defect

Boston Scientific StoneSmart Connect Console

The StoneSmart Connect Console has a power adapter with a grounding path issue that may fail safety testing.

Moderate risk, FDA, Device defect

Medical Action Blood Culture Collection Kits

Medical Action Blood Culture Collection Kits contain applicators with an open or incomplete seal that may compromise sterility and lead to infection.

Moderate risk, FDA, Sterility problem

Elegant Foods Carrot Cake, Coconut Flakes, and Golden Raisins

Coconut flakes and golden raisins contain undeclared sulfites, and carrot cake has undeclared Yellow #5 and #6.

Moderate risk, FDA, Undeclared allergen

Howmedica Osteonics Orthopaedic Implant Components

Orthopaedic implant components made with aged polyethylene may wear excessively.

Moderate risk, FDA, Device defect

restor3d Kinos Axiom Total Ankle System with Axiom PSR, Flat-Cut (Cut Guide)

The Kinos Axiom Total Ankle System was packaged with incorrect cutting guides, which may cause delayed surgery, poor alignment, or implant loosening.

Moderate risk, FDA, Device defect

Hemospray Endoscopic Hemostat

Hemospray Endoscopic Hemostat has an issue with endoscope adherence and inability to spray powder.

Moderate risk, FDA, Device defect

Wild Coast Brew Loose-Leaf Teas

The Shadow, The Creator, and The Lover loose-leaf teas contain Ashwagandha root, an unsafe food additive.

Low risk, FDA, Ended, Undeclared color or additive

Embecta Nano Pro Un-Cannulated Demo Samples

Pen needles labeled 'For Investigational Use Only' were distributed as commercially marketed devices.

Moderate risk, FDA, Labeling error

American National Red Cross Red Blood Cells and PF24 Plasma

American National Red Cross Red Blood Cells and PF24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

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

16 recalls that day

So Delicious Dairy Free Salted Caramel Cluster Cashewmilk, Non-Dairy Frozen Dessert

So Delicious Dairy Free Salted Caramel Cluster Cashewmilk may contain small stones and other hard objects.

Moderate risk, FDA, Foreign object

Bettergoods Lemon Alfredo Fettuccine

Lemon Alfredo Fettuccine may be contaminated with Listeria, which can cause serious infections.

High risk, FDA, Listeria

Taro Nystatin Cream

The cream failed stability specifications.

Moderate risk, FDA, Quality testing problem

Amneal Phytonadione Injectable Emulsion

The product failed impurities and degradation specifications.

Low risk, FDA, Drug impurity

Mercer's Ice Cream Sandwiches

Mercer's ice cream sandwiches may contain undeclared peanuts.

Moderate risk, FDA, Undeclared peanut

VERIQA RT MonteCarlo 3D v3 Software

When a bolus is included in a treatment plan and sent for secondary dose calculation, the software accounts for it but does not display this clearly.

Moderate risk, FDA, Software defect

Straumann GM Helix Implant

The GM Helix Implant has a discrepancy between its packaging identification and the dimensions of the implant inside.

Moderate risk, FDA, Device defect

SunMed Tracheal Tube

The SunMed Tracheal Tube, Size 2.5, may not allow a suction catheter to pass through smoothly.

Moderate risk, FDA, Device defect

GE Healthcare Centricity Enterprise Archive, Enterprise Archive, Centricity PACS, Centricity PACS Server, Workflow Core Services, and Core Services Hub Software

GE Healthcare products may associate imaging data with the wrong patient, potentially leading to misdiagnosis or delayed care.

Moderate risk, FDA, Device defect

NOxBOXi Nitric Oxide Delivery System

The NOxBOXi Nitric Oxide Delivery System may leak oxygen tubing, potentially causing oxygen desaturation.

Moderate risk, FDA, Device defect

Happiest Baby SNOO Sleep Sacks

Extra small and extra large SNOO Sleep Sacks have not been reviewed for safety and effectiveness by the FDA.

Moderate risk, FDA, Device defect

American National Red Cross Apheresis Plasma

Apheresis PF24RT24 Plasma, collected in a manner that compromises the sterility of the collection system, were distributed.

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

American Natl. Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were distributed from a donor with travel history to a malaria endemic area but not assessed for residency.

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

BD Alaris Pump Infusion Sets

BD Alaris Pump Infusion Sets have discrepancies in performance data that may lead to inappropriate pump performance.

High risk, FDA, Device defect

Innovative Blood Resources Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who previously tested reactive for Hepatitis B core antigen.

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

American National Red Cross Red Blood Cells and Pooled Cryoprecipitated AHF

The products were collected from a donor who previously tested reactive for the antibody to Hepatitis B core antigen on more than one occasion.

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

7 recalls that day

A&P Creations biQ-FEL and X10 Natural Enhancement Supplements

A&P Creations biQ-FEL and X10 Natural Enhancement Supplements contain undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

Halyard IV Start Kits

The Halyard IV Start Kit contains applicators contaminated with Aspergillus penicillioides.

High risk, FDA, Contamination

Medline Convenience Kits

Medline Convenience Kits contain sterile applicators that may have fungal contamination, which can lead to serious infection or death.

High risk, FDA, Contamination

Safecor Health Fluphenazine HCl Oral Elixir

Safecor Health Fluphenazine HCl Oral Elixir failed stability specifications.

Moderate risk, FDA, Quality testing problem

New York Blood Center Enterprises Plasma and Red Blood Cells

Plasma and red blood cells were collected in expired collection kits and distributed.

Low risk, FDA, Ended, Hospital use

Nuclein DASH Rapid PCR Instrument

The DASH Rapid PCR Instrument has a software issue.

Moderate risk, FDA, Software defect

LifeShare Blood Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced had a platelet count higher than acceptable.

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

14 recalls that day

Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme

Cabricharme cheese contains undeclared egg allergen, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared egg

Centric Compounding Glutathione, Myers Cocktail and Tri-Immune Boost Injections

Centric Compounding injections were compounded with a Glutathione API containing elevated endotoxin levels.

High risk, FDA, Sterility problem

Rapture Pre Workout Berry Mojito, Electric Lemonade, and Rainbow Twist Dietary Supplement

Leader Formulas products contain DMAA, which can cause cardiovascular problems.

High risk, FDA, Hidden drug ingredient

Taro Lidocaine Ointment

The product failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

Bayer Medical Care MEDRAD Stellant FLEX Syringe Kit

The syringe kit may not have been properly sterilized due to a manufacturing sterilization issue.

Moderate risk, FDA, Device defect

Maquet Cardiopulmonary Percutaneous Insertion Kits and Guidewires

The Percutaneous Insertion Kit may not maintain sterile barrier integrity.

Moderate risk, FDA, Sterility problem

Carescape Central Station

Carescape Central Station may not resume patient monitoring for at least 3 minutes after restart, delaying recognition of clinical events.

Moderate risk, FDA, Device defect

Bravo CF Capsule Delivery Device

The Bravo CF capsule delivery device may fail to attach the capsule, risking aspiration, perforation, and bleeding.

High risk, FDA, Device defect

Medline Open Heart A Pack Convenience Kit

The Medline Convenience Kit contains a cannula that may have a sterile barrier breach, risking infection or other complications.

Moderate risk, FDA, Sterility problem

Philips Patient Information Center iX and Philips PIC iX Essentials

Philips Patient Information Center iX and Philips PIC iX Essentials may freeze and become unresponsive due to software malfunction.

Moderate risk, FDA, Software defect

StatStrip Glucose Meters

A software issue can cause the meter to retain a previously scanned barcode, leading to a glucose result being assigned to the wrong patient's medical record.

High risk, FDA, Software defect