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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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10 recalls that day

Philips Avalon Fetal Monitor

Philips Avalon Fetal Monitor has incorrect speaker connector assembly that can cause loss of speaker output.

Moderate risk, FDA, Device defect

Boichik Bagels Whitefish Salad, Tuna Salad and Pumpernickel Bagels

Whitefish Salad and Tuna Salad have undeclared eggs, and Pumpernickel Mix Bagels have undeclared sesame.

Moderate risk, FDA, Undeclared egg

Intuitive Surgical Da Vinci PSS SP1098

Da Vinci surgical system components may have a pin issue that can cause uncontrolled motion.

Moderate risk, FDA, Device defect

TMJ Solutions Bilateral Implants

Custom temporomandibular joint implant may have contained incorrect patient-specific components, leading to a poor fit and a right-sided open bite.

Moderate risk, FDA, Device defect

Blood Bank of Hawaii Apheresis Red Blood Cells, Pooled Cryoprecipitated AHF and Red Blood Cells

Apheresis Red Blood Cells, Leukocytes Reduced, collected from a donor who had a hepatitis exposure prior to donation, were distributed.

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

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced tested non-reactive for anti-HCV but were collected from a donor who previously tested repeatedly reactive.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 99004

LifeShare Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from an unsuitable donor due to a donor screening deviation.

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

16 recalls that day

MorningStar Farms Plant Protein Nuggets and Sausage Patties

MorningStar Farms Buffalo Chik'n Nuggets and Hot & Spicy Sausage Patties may contain plastic pieces.

Moderate risk, FDA, Ended, Contamination

Keystone Topical Anesthetic Gels

Keystone Topical Anesthetic Gels may come in containers with incomplete seals.

Moderate risk, FDA, Packaging defect

Fairhope Roasting Company Cold Brew Coffee Concentrate

Fairhope Roasting Company Cold Brew Coffee Concentrate lacks a required refrigeration label.

Moderate risk, FDA, Ended, Labeling error

Datex-Ohmeda Giraffe and Panda Infant Resuscitation Systems

Blender knob shaft can loosen, which can affect the delivered oxygen concentration.

High risk, FDA, Device defect

HeartMate 3 Left Ventricular Assist System Kits, System Controller, and Backup Battery

The products may fail due to 11 volt Backup Battery failures.

Moderate risk, FDA, Device defect

International Food Products Dairy Powders and Dressing Stabilizer

Legacy Tex Dressing Stabilizer Blend tested positive for Salmonella, and Dairy House Vanilla and Strawberry Dairy Powders have potential for Salmonella.

Moderate risk, FDA, Ended, Salmonella

United Salt Plain and Iodized Salt

Plain salt was labeled as iodized and iodized salt was labeled as plain.

Low risk, FDA, Ended, Labeling error

STAAR ICL Calculation Software

The Staar ICL Calculation Software has a coding issue that affects the implant orientation diagram for toric lenses.

Moderate risk, FDA, Software defect

Inspire Respiratory Sensing and Stimulation Lead

The Inspire Respiratory Sensing Lead is labeled with an incorrect Use By Date, which may lead to premature revision surgery.

Moderate risk, FDA, Labeling error

Adndale Magnesium Glycinate Gummies

Adndale Magnesium Glycinate Gummies contain undeclared melatonin.

Moderate risk, FDA, Ended, Undeclared color or additive

Impella CP Set with SmartAssist

Impella CP Set with SmartAssist may cause low purge pressure alarms and interruption of circulatory support.

High risk, FDA, Device defect

BD Connecta Stopcocks

BD Connecta BD Luer-Lok 360 Stopcocks may have an unstable connection at Port C when used with a plastic luer-lok syringe.

Moderate risk, FDA, Device defect

Merit Medical Systems Splashwire Hydrophilic Guide Wire

The Splashwire Hydrophilic Guide Wire has unsealed portions of pouches.

Moderate risk, FDA, Packaging defect

Beta Bionics iLet Bionic Pancreas

This can lead to hyperglycemia.

Moderate risk, FDA, Software defect

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had no hematocrit check performed during screening.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98960

Rhode Island Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98956

8 recalls that day

Endo Buprenorphine HCl Injection

Buprenorphine HCl injection can crystallize, identified as Buprenorphine free base.

Moderate risk, FDA, Quality problem

Howmedica Osteonics Tri TS Baseplate

Triathlon Universal Baseplate Size 3 and Size 4 are in packaging labeled with the other size.

Moderate risk, FDA, Labeling error

Medline Urethral Catheters and Procedure Kits

Medline Industries is recalling 30 products.

Moderate risk, FDA, Quality testing problem

GE HealthCare Giraffe OmniBed Devices

GE HealthCare has become aware of a potential issue involving the canopy soffit beneath the control panel end of the device.

Moderate risk, FDA, Device defect

ConMed AirSeal Access Ports and Obturators

ConMed AirSeal Access Ports and Obturators have a potential for overpressure alerts.

Moderate risk, FDA, Device defect

Mito Red Light Super Mobile

The near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames.

Moderate risk, FDA, Device defect

Department of Air Force Apheresis Platelets, Leukocytes Reduced

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

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

ImpactLife Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who answered "no" to reading educational materials.

Low risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98937

10 recalls that day

Philips MultiDiagnost Eleva and Allura Xper Systems

Philips MultiDiagnost Eleva and Allura Xper systems have a hand switch that may not release, causing loss of imaging or unintended radiation.

Moderate risk, FDA, Device defect

Nutrisystem Chocolate Cheesecake

Nutrisystem Chocolate Cheesecake contains undeclared soy.

Moderate risk, FDA, Undeclared soy

Al Yaman Halawa Extra Pistachio

Al Yaman Halawa Extra Pistachio may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

Great Value Hawaiian Rolls

Great Value Hawaiian Roll has an oily and sticky substance on its packaging.

Moderate risk, FDA, Ended, Quality problem

AMD Medicom Ritmed Neurological Sponges

The sponges may not consistently meet endotoxin specification for devices that contact cerebrospinal fluid.

Moderate risk, FDA, Contamination

DirectCHECK ACT-LR Whole Blood Quality Control, Level 2

The directCHECK ACT-LR whole blood quality control has labeling with an incorrect performance range.

Moderate risk, FDA, Labeling error

Mid Dolciaria Sicilian Cannoli and Crunchy Gluten Free Cannoli

Cannoli Siciliani and Crunchy Cannoli Gluten Free contain unapproved colors.

Moderate risk, FDA, Undeclared color or additive

Smith & Nephew Trigen Proximal Straight Humeral Nail

The humeral nail is missing distal holes and may lead to revision surgery if implanted.

Moderate risk, FDA, Manufacturing problem

We Are Blood Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were collected from a donor who had taken aspirin within 72 hours of donation.

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

Community Blood Center of the Ozarks Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

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

9 recalls that day

FIRST STREET Dark Chocolate Raisins

Dark chocolate raisins may contain undeclared peanuts, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared peanut

Ajanta Pharma Aripiprazole Tablets

Aripiprazole Tablets USP 30 mg are mislabeled, containing Voriconazole Tablets 50 mg instead.

Moderate risk, FDA, Labeling error

Medtronic O-Arm O2 Imaging System

The system's detector panel firmware has an anomaly that can cause image artifacts.

Moderate risk, FDA, Software defect

ALYON and HarmonyAIR A-Series Surgical Lighting System

The surgical lighting systems may have light intensity control buttons that detach.

Moderate risk, FDA, Device defect

HarmonyAIR A-Series Surgical Lighting System

The HarmonyAIR A-Series Surgical Lighting System has paint that can chip or peel on its light heads.

Moderate risk, FDA, Device defect

Blood Bank of Hawaii Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

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

Coastal Bend Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who had traveled to a malaria-endemic area.

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

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor who was a resident of a malaria endemic area.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98882

Suncoast Communities Blood Bank Red Blood Cells, Leukocytes Reduced

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

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 98878