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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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6 recalls that day

CASE v7.0 Cardiac Testing System

The CASE v7.0 Cardiac Testing System can spark at the printer head, potentially causing serious thermal injury.

Moderate risk, FDA, Device defect

HiResolution Bionic Ear System Cochlear Implants

The HiResolution Bionic Ear System has an incorrect shelf-life expiration date.

Moderate risk, FDA, Labeling error

Neptune Smart Docking Station

The Neptune Smart Docking Station may not have completed required testing and poses a risk of electrical shock.

Moderate risk, FDA, Device defect

Covidien EndoStitch Polysorb Single Use Loading Unit

The Covidien EndoStitch Polysorb Single Use Loading Unit may have holes in its pouch, compromising the sterile barrier.

Moderate risk, FDA, Sterility problem

Philips Azurion 3M12, 3M15, 5M12 and Other Angiography Systems

Philips Azurion Systems may show a dark image that is not clinically usable during Roadmap Pro.

Moderate risk, FDA, Device defect

11 recalls that day

Motor City Pizza Co. 5 Cheese Bread

Motor City Pizza Co. 5 Cheese Bread may be contaminated with Salmonella, which can cause serious infections.

Moderate risk, FDA, Ended, Salmonella

Udder Products Yeast Blend

Udder Products Yeast Blend has elevated selenium levels.

Not yet rated, FDA, Wrong nutrient levels

Eugia Lidocaine HCl Injection

Lidocaine HCl Injection has a label wrap that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

Guittard Chocolate Company 72% Cacao Chocolate with Date Sugar Wafers

72% Cacao chocolate with date sugar wafers may be contaminated with Salmonella.

High risk, FDA, Salmonella

Fresenius Kabi Ivenix Infusion System (IIS), Large Volume Pump

The Ivenix Large Volume Pump can be damaged by dropping or jarring, causing unintended touchscreen behavior.

High risk, FDA, Device defect

B. Braun Anesthesia and Catheter Trays

B. Braun anesthesia and catheter trays contain Mastisol Liquid Adhesive, whose tubing may crack, which renders the product unusable.

Moderate risk, FDA, Device defect

Covidien Mon-a-Therm Temperature Probes and Esophageal Stethoscope

Temperature probe devices lack FDA clearance.

Moderate risk, FDA, Unapproved product

Exacta Mix Vented Micro-Volume Inlet

Vented Micro-Volume Inlet tubing sets may contain incorrect filters, reducing flow efficiency and causing clinical effects.

Moderate risk, FDA, Device defect

Becton Dickinson & Company BD Spinal Trays

BD Spinal Tray with BD Quincke Needle has quality issues identified during an FDA inspection.

High risk, FDA, Device defect

COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula

The Shiley Tracheostomy Tube has incorrect display box labeling.

Moderate risk, FDA, Labeling error

Fresenius Kabi Ivenix Infusion System Large Volume Pump

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) has a potential for the Cassette Loading Lever to break.

Moderate risk, FDA, Device defect

7 recalls that day

GE HealthCare Carescape Telemetry Server

With the Carescape Telemetry Server, a persistent No Comm or Off Network condition can result in potential loss of ECG and SpO2 monitoring.

Moderate risk, FDA, Device defect

Medtronic 1x4 and 2x4 Pocket Adaptor Kit for Deep Brain Stimulation

The Pocket Adaptor Kits for Deep Brain Stimulation have incorrect Use-By-Dates.

Moderate risk, FDA, Labeling error

Medline Eye Tray-LF Medical Convenience Kit

The Medline medical convenience kit labeled as Eye Tray-LF contains syringes that are mislabeled.

Moderate risk, FDA, Labeling error

Medline Anesthesia and Spinal Trays

Medline kits containing Huons Bupivacaine in Dextrose Injection have quality issues, including data integrity concerns and efficacy complaints.

High risk, FDA, Device defect

Philips Azurion and Allura Systems

A system restart may temporarily restore functionality.

Moderate risk, FDA, Device defect

Better Weather Actives Fix Elixir

Better Weather Fix Elixir may contain undeclared Mitragynine and Mitragynine Pseudoindoxyl, which can cause nausea, vomiting, and rapid heart rate.

Not yet rated, FDA

Abiomed Impella Controllers

The Automated Impella Controller has alarm failures, power-path faults, electrical-short risks, and inaccurate motor-current sensing.

High risk, FDA, Device defect

4 recalls that day

Bazzini Dark Chocolate Coconut Almond Bites

Dark Chocolate Coconut Almond Bites may contain undeclared peanuts, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared peanut

D'Dioses Ice Pop

Ice pops may contain undeclared milk, tree nuts, and colors, posing a risk of serious allergic reactions.

High risk, FDA, Undeclared milk

AbbVie Pred Mild Ophthalmic Suspension

Pred Mild ophthalmic suspension failed stability specifications.

Low risk, FDA, Quality testing problem

HydroMARK Breast Biopsy Site Marker

The HydroMARK Breast Biopsy Site Marker has incorrect inner package labeling.

Moderate risk, FDA, Labeling error

6 recalls that day

Omnipod 5 Pods, Omnipod DASH Pod, and Omnipod (Eros) Pod

Omnipod insulin pods may leak insulin due to cannula damage, causing under-delivery and high blood glucose.

High risk, FDA, Device defect

Total Nutrition Moringa Capsules

Moringa capsules may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Dexcom G7 Continuous Glucose Monitoring System

Dexcom G7 sensors from two lots were stolen and sold, posing risks of skin infection or missed readings.

Moderate risk, FDA, Device defect

Aveva Nicotine Transdermal System Patch

Aveva Nicotine Transdermal System Patch may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who traveled and lived in a malaria endemic area.

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

ImpactLife PF24RT24 Plasma

PF24RT24 Plasma was distributed after incomplete donor eligibility screening.

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

1 recall that day

MOGO Pure Moringa Oleifera Capsules

Mogo Pure Moringa Oleifera Capsules may be contaminated with Salmonella Typhimurium.

High risk, FDA, Salmonella

8 recalls that day

Raaw Energy: 37 products

Raaw Energy is recalling its Raaw Energy because of potential Listeria contamination.

High risk, FDA, Listeria

Angel, Boba Time, Denda, Fanale and Royal Gold Drink Powders

Angel, Boba Time, Denda, Fanale and Royal Gold Drink Powders may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Lloyd ToxiBan Charcoal-Kaolin Suspension

Microbial levels in the oral medication exceeded specification limits.

Moderate risk, FDA, Contamination

My Pet Carnivore and The Butcher's Hound Frozen Raw Pet Food

My Pet Carnivore and The Butcher's Hound Frozen Raw Pet Food have potential Listeria contamination.

High risk, FDA, Ended, Listeria

Honeyville Banana Smoothie Bulk Super Sack Tote

The banana smoothie bulk product may be contaminated with Salmonella.

High risk, FDA, Salmonella

Halyard Purezero Ultraviolet Nitrile Exam Gloves

The gloves failed to meet chemical permeation performance specifications.

Moderate risk, FDA, Quality testing problem

Automated Impella Controller (AIC)

The Automated Impella Controller may interrupt motor controls, cause startup failures, or lead to boot-up failure.

High risk, FDA, Device defect

RelayPro Thoracic Stent-Graft System

The RelayPro Thoracic Stent-Graft System may have a proximal clasp disconnection that prevents release from the delivery system.

High risk, FDA, Labeling error

9 recalls that day

Whole Foods Market Kitchens Minestrone Soup

Minestrone soup contains undeclared shrimp, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared shellfish

JXK Enterprises Boner Bears Chocolate

Boner Bears Chocolate contains undeclared sildenafil, which may pose serious health risks.

High risk, FDA, Hidden drug ingredient

IntegraDose Compounding Services Fentanyl Citrate Injection

FentaNYL Citrate, Sterile CADD for Injection may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Nephronex Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement Oral Liquid

The oral liquid supplement contains black particles.

Moderate risk, FDA, Foreign object

Solina Seasonings and Blends

Solina Seasonings and Blends may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Fontana Flavors Cheese and Mushroom Flavorings

Fontana Flavors Cheese and Mushroom Flavorings were made with milk powder recalled by the supplier due to Salmonella contamination.

High risk, FDA, Ended, Salmonella

Philips Azurion Systems

Philips Azurion systems may have impacted table movements due to mechanical wear of the Float Tabletop control.

Moderate risk, FDA, Device defect

Philips Azurion, Allura and Integris-Allura Systems

The deaeration hose in X-ray tube cooling units may degrade over time, potentially resulting in oil leakage.

Moderate risk, FDA, Device defect