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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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23 recalls that day

Halyard LAVH Packs

The kit component was subjected to EO sterilization, contrary to the manufacturer recommendation, which may have led to the component leaking in a kit.

Moderate risk, FDA, Device defect

Getinge Y Sensor Module, Servo-U, Servo-N

The Y sensor module for SERVO-U/-N ventilators did not undergo electrical safety and functional tests during production.

Moderate risk, FDA, Device defect

Boston Scientific OverStitch Suture Cinch and Suture Cinch Long

Device may fail to deploy the cinch implant and/or fail to cut the suture as intended.

Moderate risk, FDA, Device defect

Prospector Popcorn Gourmet Popcorn

Prospector Popcorn Chocolate Mocha Gourmet Popcorn has inaccurately declared nutrients, including understated carbohydrates and cholesterol.

Moderate risk, FDA, Wrong nutrient levels

Tobii Dynavox TD Navio Maxi and Midi Speech Generating Device

TD Navio Midi and Maxi Speech Generating Devices may have damaged battery mounting tabs, causing internal short circuit and heating.

Moderate risk, FDA, Device defect

Arrowhead DE Arrow-LOK Implant

The Arrow-LOK Implant did not undergo required gamma radiation dose audit, which could lead to patient infection.

Moderate risk, FDA, Sterility problem

Kico Knee Innovation Arvis Surgical Navigation System GEN 2

The ARVIS surgical navigation system may show a tilted image due to an internal sensor issue.

Moderate risk, FDA, Device defect

Philips Cardiac Workstation 5000 and 7000

Philips Cardiac Workstation 5000 and 7000 may intermittently provide inaccurate heart rate data.

Moderate risk, FDA, Device defect

Dentsply Sirona Capsule Mixer

The Dentsply Sirona Capsule Mixer can discharge electricity when unplugged.

Moderate risk, FDA, Device defect

Intersurgical Guedel Oropharyngeal Airways

The One-Piece Guedel Airway could be occluded or partially occluded.

Moderate risk, FDA, Device defect

Foundation Medicine Hamilton Microlab STAR Liquid Handler

The Hamilton Microlab STAR Liquid Handler has a software issue that can cause increased spontaneous software closures.

Moderate risk, FDA, Software defect

EndoFLIP System

The EndoFLIP System can incorrectly flag catheters as expired, making them unavailable for clinical procedures.

Moderate risk, FDA, Device defect

8 recalls that day

Grand Central Bakery Potato Sourdough Bread

Potato Sourdough Bread may contain metal pieces, which can cause injury.

Moderate risk, FDA, Foreign object

Shoolin Pharma Chem Sildenafil Citrate and Tadalafil

Shoolin Pharma Chem is recalling its Sildenafil Citrate Usp and Tadalafil Usp because of CGMP deviations, as Noted during FDA inspection.

Moderate risk, FDA, Manufacturing problem

CLEAR EYES Maximum Itchy Eye Relief

Clear Eyes Maximum Itchy Eye Relief lacks assurance of sterility due to potential contamination.

Moderate risk, FDA, Sterility problem

New York Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor previously deferred for hepatitis C virus antibody testing.

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

Hoxworth 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, FDA event number 99471

Cardinal Health Presource Kits

Procedure kits contain neurological sponges with unexpected variability in endotoxin levels.

Moderate risk, FDA, Contamination

BD Intravascular Administration and Extension Sets

Intravascular administration sets may not have been sterilized correctly.

Moderate risk, FDA, Sterility problem

Walter L. Shepeard Community 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

10 recalls that day

Oma's Pride Pet Food Woof Complete Canine Chicken Recipe

Woof Complete Canine Chicken Recipe may be contaminated with Salmonella, which can affect animals and risk humans handling it.

High risk, FDA, Salmonella

Marketside Tomato Bisque Soup Kit

Marketside Tomato Bisque Soup Kit may be contaminated with Listeria, which can cause serious infections.

Moderate risk, FDA, Listeria

Dairyland Produce Pepper Jalapeno

Jalapenos may be contaminated with Salmonella.

High risk, FDA, Salmonella

Whole Foods Guacamole Dips, Salsas and Trio Dip

Whole Foods Guacamole Dips, Salsas and Trio Dip may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

LifeShare Blood Centers Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed after incomplete donor eligibility screening.

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

LifeShare 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 99418

Erbe USA ERBECRYO 2 Cryosurgical Unit

The Erbecryo 2 Cryosurgical Unit can rupture due to excessive pressure from a pneumatic short circuit.

Moderate risk, FDA, Device defect

ProNephro AKI (NGAL) Reagent Kit

The ProNephro AKI (NGAL) Reagent Kit may lead to missed diagnosis of renal disease.

Moderate risk, FDA, Device defect

BIOFIRE Respiratory Panel 2.1 (RP2.1)

The Biofire Respiratory Panel 2.1 may give false negative results.

Moderate risk, FDA, Device defect

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were prepared from whole blood that exceeded the acceptable collection volume.

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

8 recalls that day

Salata Jalapeño Avocado Dressing

Salata Salad Kitchen Jalapen¿o Avocado Dressing may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Vitasia Asian Style Wok Spice Mix

Vitasia Asian Style Wok Spice Mix may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

Schwarzkopf Professional Osis Grip Mousse

Schwarzkopf Professional Osis Grip Mousse can leak under pressure, creating a risk of explosion.

Moderate risk, FDA, Packaging defect

Frankie's Organic Plant-Based Puffs Vegan Cheddar

Frankie's Organic Plant-Based Puffs Vegan Cheddar may contain undeclared milk, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared milk

Straumann Bone Level Tapered (BLT) Implant

The Bone Level Tapered Implant may contain implants that are 12mm in length instead of 14mm as labeled.

Moderate risk, FDA, Labeling error

Waldemar Link Endo-Model Tibial Plateau Replacement Sets

The Endo-Model replacement set for a tibial plateau incorrectly contains a Pure Hinge plateau, which could lead to prolonged surgery or implant wear.

Moderate risk, FDA, Device defect

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter

Baxter Duo-Vent Solution Set and Male Luer Lock Adapter can have air bubbles in the drip chamber and tubing.

High risk, FDA, Device defect

Spectra Medical Devices Sodium Chloride Injection

Sodium Chloride Injection may have compromised sterility, exposing patients to microorganisms, endotoxins, or foreign matter.

High risk, FDA, Sterility problem

10 recalls that day

Tyenne (Tocilizumab-Aazg) Injection

Tyenne (tocilizumab-aazg) Injection contains glass particles that can cause irritation, vein inflammation, and serious blood vessel blockage.

High risk, FDA, Foreign object

Avet Pharmaceuticals Clindamycin Palmitate Hydrochloride for Oral Solution

Clindamycin palmitate hydrochloride oral solution contains particles and white flakes in reconstituted bottles.

Moderate risk, FDA, Foreign object

OBP Medical ER-Spec Single-Use Vaginal Speculum with LED Light Source

The ER-Spec Single-Use Vaginal Speculum may have a sharp edge on its blade.

Moderate risk, FDA, Device defect

Philips Azurion

Philips Azurion x-ray system has software issues that may delay therapy and cause complications.

Moderate risk, FDA, Software defect

Philips Azurion Interventional Fluoroscopic X-Ray Systems

Philips Azurion Rystem has software issues that may delay therapy and cause procedural complications.

Moderate risk, FDA, Software defect

Hoxworth 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, FDA event number 99417

Straumann GM Helix Dental Implants

There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.

Moderate risk, FDA, Labeling error

Philips Allura Xper FD Interventional Fluoroscopic X-Ray Systems

Allura Xper FD has a firmware issue that could lead to loss of geometry movements.

Moderate risk, FDA, Software defect

Terumo Glidesheath Slender A-Kit

The Glidesheath Slender was packaged with the 0.025 guidewire instead of the 0.021 guidewire.

Moderate risk, FDA, Device defect

LifeShare 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 99416

1 recall that day

Taylor Fresh Foods: 25 products

The products may be contaminated with Salmonella.

High risk, FDA, Salmonella

1 recall that day

NatureBest Pre-Cut & Produce Pico de Gallo, Jalapeño Peppers and Stuffed Mushrooms

NatureBest Pre-Cut & Produce mushrooms may be contaminated with Salmonella.

High risk, FDA, Salmonella