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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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15 recalls that day

Microgenics MAS Omni IMMUNE PRO Immunoassay Controls

MAS Omni Immune Pro Liquid Assayed Integrated Immunoassay Control has vial-to-vial variability that may delay patient PTH results.

Moderate risk, FDA, Device defect

Family Farmstead Dairy Raw Mild Cheddar Cheese

Raw Mild Cheddar Cheese may be contaminated with E. coli O26:H11 and O45:H2, which can cause diarrheal illness.

Not yet rated, FDA

7 recalls that day

American Health Packaging Metoclopramide Tablets

Metoclopramide Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Holsum Spinach Flour Tortillas Large

Holsum Spinach Flour Tortillas contain undeclared colors.

Moderate risk, FDA, Undeclared color or additive

Gore Viabil Short Wire Biliary Endoprosthesis

The Gore Viabil Short Wire Biliary Endoprosthesis may be mislabeled with the incorrect length.

Moderate risk, FDA, Labeling error

In2bones CoLag Screw FT

Bone screws labeled as fully threaded are actually partially threaded.

Moderate risk, FDA, Labeling error

Gerber & Sons / ADM Bob White Turkey Grower/Finisher Pellet and Turkey Starter Crumble

Gerber & Sons / Adm is recalling Bob White Turkey Grower/Finisher Pellet and Bob White Turkey Starter Crumble because of Vitamin B2 deficiency in turkey feed.

Moderate risk, FDA, Wrong nutrient levels

Steris Rapicide PA Part A High-Level Disinfectant

Rapicide PA Part A High-Level Disinfectant may swell if its vented cap is blocked, and liquid may escape when opened.

Moderate risk, FDA, Device defect

Ethicon PERMA-HAND Silk Surgical Suture

Silk sutures packaged with alcohol-based fluid may cause surgical delay if discovered before use.

Moderate risk, FDA, Device defect

7 recalls that day

Par Pharmaceutical Argatroban Injection

Argatroban Injection may contain particulate matter that can cause life-threatening health problems.

High risk, FDA, Foreign object

Pan Pepin ParaBien Al Grano

ParaBien Al Grano contains undeclared sesame.

High risk, FDA, Undeclared sesame

Zydus Hydrocortisone Sodium Succinate for Injection

Hydrocortisone Sodium Succinate for Injection, USP 100 mg/vial may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Teva Metoclopramide Tablets

Metoclopramide Tablets may contain foreign tablets or capsules.

Moderate risk, FDA, Foreign object

Houston Rx Sermorelin and Tirzepatide/Niacinamide Injections

Tirzepatide/Niacinamide vials lack assurance of sterility, and Sermorelin vials lack process control.

Moderate risk, FDA, Sterility problem

Baxter Likorall Overhead Lifts

Likorall Overhead Lifts may lower the lift strap more quickly than expected, posing a risk of injury from a fall.

Moderate risk, FDA, Device defect

BioFire FilmArray Pneumonia and Joint Infection Panels

The FilmArray Pneumonia Panel, Pneumonia Panel plus, and BioFire Joint Infection Panel may give false positive results due to contamination.

Moderate risk, FDA, Device defect

1 recall that day

Instrumentation Laboratory HemosIL AcuStar HIT-IgG(PF-4)

HemoslL AcuStar HIT-lgG(PF-4) may have an invalid calibration curve or negative mean bias with patient samples.

High risk, FDA, Device defect

13 recalls that day

Riad's Oliva to Go Baba Ghanouj, Spicy Baba Ghanouj and Hummus

Riad's Oliva to Go Baba Ghanouj, Spicy Baba Ghanouj, and Hummus contain undeclared sesame, which can cause serious allergic reactions.

High risk, FDA, Undeclared sesame

Starfish Seafood Cold Smoked Salmon, Halibut and Trout

Starfish Seafood Cold Smoked Salmon, Halibut and Trout have Listeria contamination.

High risk, FDA, Listeria

Integrated Medcraft FORWARD Gunshot Wound Kit

The Forward Gunshot Wound Kit has a sterile pad that may degrade over time, potentially dislodging remnants on the wound.

Moderate risk, FDA, Device defect

SI-BONE iFuse TORQ Implant System

The iFuse TORQ Implant System may not be sterile because its packaging seal integrity failed testing.

Moderate risk, FDA, Sterility problem

Ferno-Washington Power F2 Powered Fastening System

Firmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher.

Moderate risk, FDA, Software defect

Sarnova HC Curaplex Capnography Oral Nasal Cannula Multipack

The Curaplex Capnography EtCO2/O2 Oral/Nasal Cannula Multipack contains pediatric cannulas instead of adult ones.

Moderate risk, FDA, Device defect

Boston Scientific NaviFlex LW Pusher and Advx Panc Stent

The NaviFlex LW Pusher; Advx Panc. Stent 4/5F was incorrectly manufactured with a guidewire exit port (referred to in the IFU as the RX port).

Moderate risk, FDA, Device defect

Neuronetics NeuroStar Advanced Therapy Systems

The cables in the NeuroStar Advanced Therapy System are not in conformance with the product specifications required in the production of the HP Coil Assembly.

Moderate risk, FDA, Device defect

Cadwell IOMAX Cortical Module

The IOMAX Cortical Module may unintentionally deliver electrical stimulation or allow unintended current to reach the patient.

Moderate risk, FDA, Device defect

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312

Becton Dickinson BD Phoenix Panels NMIC-306 and NMIC-312 may have quality control failures with Klebsiella pneumoniae when using a certain feature.

Moderate risk, FDA, Device defect

Medtronic Sofamor Danek Grafton DBM and Grafton Plus DBM Bone Grafts

Grafton DBM and Grafton Plus DBM may cause infection if implanted.

Moderate risk, FDA, Contamination

JenaValve Trilogy Delivery Catheters

The Jenavalve Trilogy Delivery Catheter may have sleeve liner separation, causing difficulty or inability to deploy the heart valve device.

Moderate risk, FDA, Device defect

Diagnostic Grifols Erytra Analyzer

The Erytra analyzer can assign incorrect results for an autocancelled and rescheduled test, potentially leading to an incident if a transfusion is performed.

Moderate risk, FDA, Ended, Software defect

7 recalls that day

Gardners Basics Waltham 29 Broccoli Sprouting Seeds

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

High risk, FDA, Salmonella

Par Brevital Sodium Methohexital Sodium

Brevital Sodium 500 mg/vial contains particulate matter that can cause life-threatening health consequences.

High risk, FDA, Foreign object

Sun Pharmaceutical Industries Tretinoin Cream

Sun Pharmaceutical Industries is recalling its Tretinoin Cream USP and Tretinoin Cream UPS because of failed Impurities/Degradation Specifications.

Low risk, FDA, Drug impurity

J&J Innovative Medicine Imaavy Injection

Imaavy (nipocalimab-aahu) Injection contains particulate matter.

Moderate risk, FDA, Foreign object

Apothecary Pharma NAD+ and Tirzepatide Injections

Tirzepatide Injection and NAD+ Injection lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables

Carolina Infusion Tirzepatide, Semaglutide and Tri-Mix Injectables lack assurance of sterility.

Moderate risk, FDA, Sterility problem

J K Patisserie & Bakery Chocolate Chip Cookies, Croissants and Lemon Blueberry Loaf

Lemon Blueberry Loaf and Chocolate Chip Cookies contain undeclared soy, and Croissant contains undeclared egg.

Moderate risk, FDA, Undeclared soy

12 recalls that day

Eden Brothers Broccoli Seeds Calabrese

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

High risk, FDA, Salmonella

Cronus Pharma AnaSed Equine Injection

AnaSed Equine Injection may be discolored, which can affect its use in horses.

Moderate risk, FDA, Quality problem

Queso Palmita Frozen Pastel de Queso Cheese Pie

Queso Palmita Pastel de Queso (Cheese Pie) has undeclared milk, with cheese declared.

Moderate risk, FDA, Undeclared milk

Steris HexaVue Focus Integration System

HexaVue Focus Integration System may mismatch patient information on printed images, causing documentation discrepancies.

Moderate risk, FDA, Software defect

LeMaitre Vascular TufTex Over-the-Wire Embolectomy Catheter

Devices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing.

Moderate risk, FDA, Device defect

Mindray DS Patient Monitors and Telemetry Monitoring Systems

Mindray DS Patient Monitors and Telemetry Monitoring Systems may have insufficient descriptions of alarm functions.

Low risk, FDA, Device defect

Intellijoint Navigation System and Intellijoint HIP Systems

The Intellijoint Navigation System has a workstation that may contain a MacBook Pro battery that may overheat and pose a fire safety risk.

Moderate risk, FDA, Device defect

Canon Medical Alphenix INFX-8000C/B5

The Alphenix INFX-8000C/B5 has loosening bolts that may cause tabletop shift and misalignment.

Moderate risk, FDA, Device defect

Polymedco Sediplast

Sediplast tubes may cause increased resistance when inserting the pipette, leading to cap detachment and potential blood exposure.

Moderate risk, FDA, Device defect

AVID Medical Custom Surgical Procedure Kits

AVID Medical Custom Surgical Procedure Kits may be contaminated with a lubricant used during manufacturing.

Moderate risk, FDA, Contamination

Sweet Sensi Elevated Edibles Hybrid Gum Drops

Sweet Sensi Elevated Edibles Hybrid Gum Drops contain Staphylococcus aureus.

Moderate risk, FDA, Contamination

Diagnostic Grifols Erytra and Erytra Eflexis Automated Blood Grouping and Antibody Test Systems

An issue in how these blood grouping systems titrate antibodies can cause minor variations in titration results.

Low risk, FDA, Ended, Device defect

6 recalls that day

Pacific Health Sciences Babies' Magic Tea and Baby Sleep Gripe Water

Pacific Health Sciences is recalling its Babies' Magic Tea because it is adulterated (elevated levels of alcohol) infant dietary supplement.

Moderate risk, FDA, Chemical contamination