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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

Preferred Pharmaceuticals Lidocaine Ointment

Lidocaine Ointment USP, 5% failed content uniformity specifications.

Moderate risk, FDA, Quality testing problem

Cipla USA Fosfomycin Tromethamine Granules for Oral Solution

Fosfomycin Tromethamine Granules for Oral Solution may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Onkos Surgical My3D Personalized Pelvic Implant

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Moderate risk, FDA, Device defect

BioSpectra Tris/Tromethamine

Biospectra Tris/Tromethamine failed stability specifications.

Moderate risk, FDA, Quality testing problem

Nihon Kohden CNS-6200 Series Central Nurse Station

The central nurse station has a cybersecurity issue that could disrupt monitoring of multiple beds and alarm visualization.

Moderate risk, FDA, Software defect

7 recalls that day

Nature's Own Hawaiian Bread

Nature's Own Hawaiian Bread contains undeclared milk, posing a risk of allergic reaction to people with milk allergy or sensitivity.

Not yet rated, FDA

American National Red Cross Apheresis Platelets

Apheresis Platelets, PAS, Leukocytes Reduced were not tested for pH or platelet yield.

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

K.C. Pharmaceuticals Eye Drops

K.C. Pharmaceuticals Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Medtronic MiniMed Flex Insulin Pumps

The MiniMed Flex insulin pump may have failed verification tests, causing issues like inaccurate insulin delivery.

Moderate risk, FDA, Device defect

Medline Bariatric Steel Rollators

The rollator's front fork stem bolt/wheel assembly may disconnect, causing the front wheels to detach and risk severe falls.

Moderate risk, FDA, Device defect

Stryker Sustainability Solutions Bard EP XT Decapolar Steerable Diagnostic EP Catheter

The diagnostic EP catheter may have a breached sterile barrier, which could lead to particulate embolization, infection, or thrombus.

Moderate risk, FDA, Sterility problem

South Texas Blood & Tissue Center Apheresis Platelets, Leukocytes Reduced

Apheresis Platelets, Leukocytes Reduced were labeled as leukocytes reduced but were not tested to verify white blood cell count.

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

14 recalls that day

Stewart's Shops Vanilla Chocolate Strawberry and Vanilla Heavenly Medley Ice Cream

Stewart's Shops is recalling its Vanilla chocolate Strawberry Ice Cream and Vanilla Heavenly Medley because foreign object, as May contain pieces of metal.

Moderate risk, FDA, Foreign object

EAK Distribution Heirloom Homegrown Green Sprouting Calabrese Broccoli Sprouts Seed

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

High risk, FDA, Salmonella

28 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange Zero

Gatorade Lemon Lime, Lemon Lime Zero, Orange, and Orange Zero contain undeclared Yellow No. 6 and/or Yellow No. 5.

Moderate risk, FDA, Undeclared color or additive

LEASA Alfalfa Sprouts and Living Alfalfa Sprouts

LEASA Living Alfalfa Sprouts may be contaminated with E. coli.

High risk, FDA, E. coli

Safeguard US Operating Battle Bandage

The compression bandage may be degraded, which may cause unwanted foreign material inside the wound, leading to infection.

Moderate risk, FDA, Foreign object

HALYARD Laparoscopy Comprehensive Pack II

Laparoscopy packs labeled as latex free contain a latex urethral catheter.

Moderate risk, FDA, Labeling error

Glypto Device, Glypto Cryo Machine

The Glypto Device and Glypto Cryo Machine lack 510(k) clearance.

Moderate risk, FDA, Unapproved product

Presource Packs Containing Medtronic Microstream Components

Presource Packs containing Medtronic Microstream Components may cause delay to treatment and unintended extubation.

Moderate risk, FDA, Device defect

Beckman Coulter DxC 500 Clinical Chemistry Analyzers

Beckman Coulter DxC 500 Clinical Chemistry Analyzers have a software issue that can cause falsely elevated results.

Moderate risk, FDA, Software defect

DRG International Sperm Ab ELISA

Sperm Ab ELISA may give false negative patient results.

Moderate risk, FDA, Device defect

Spectral CT and Spectral CT 7500 RT

Spectral CT systems have software issues that may affect safety and performance.

Moderate risk, FDA, Software defect

Steris VERIFY Biological Steam Test Packs and Biological Indicators

Verify biological indicators and test packs may show no growth even if the steam cycle did not achieve the intended spore reduction.

Moderate risk, FDA, Device defect

Medical Action Industries Kit: Urinary Clean Catch 20/cs

An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.

Low risk, FDA, Labeling error

ADAPTABLE Beach Chair Surgical Patient Positioner

The Adaptable Beach Chair surgical patient positioner has an inadequate weld in the head positioning system.

Moderate risk, FDA, Manufacturing problem

22 recalls that day

Greenwich Rx Glutathione Injection

Glutathione Injection may contain elevated endotoxin levels, which could cause fevers, hypotension, inflammatory reactions, anaphylactic shock and death.

High risk, FDA, Sterility problem

WinCo Foods Salsa Bean Dip Trays

The affected peperoncini may have been used as an ingredient on the trays with certain best-if-used-by dates.

Moderate risk, FDA, Foreign object

Saint Francis Apizza Frozen Cheese, Mushroom & Onion, Pepperoni, and Supreme Pizzas

Frozen pizzas contain undeclared soy allergen, posing a risk of serious allergic reaction to people with soy allergy.

Moderate risk, FDA, Undeclared soy

PHP Animal Health Pet Drops Lubricant Eye Drops

PHP Animal Health Pet Drops Lubricant Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Khazana The Treasure Spice Magic Fennel Candy

Khazana The Treasure Spice Magic Fennel Candy contains undeclared Yellow 5 & 6, Red 3, and Blue 1.

Moderate risk, FDA, Undeclared color or additive

Amazon Extra Strength Acetaminophen Caplets

Acetaminophen Extra Strength caplets have discolored tablets.

Moderate risk, FDA, Quality problem

Todd's Seeds Sprouting Seeds

Todd's Seeds Sprouting Seeds may be contaminated with E. coli and/or Salmonella.

High risk, FDA, Salmonella

Glenmark Pharmaceuticals Clindamycin Phosphate Foam, 1%

Clindamycin Phosphate Foam, 1%, for topical use, comes in a defective container that can leak.

Moderate risk, FDA, Packaging defect

Omni Gold Anti-Marks Cream Extra Brightening and Orbi 20

Orbi 20 Whitening Cream and Omni Gold Anti-Marks Cream are contaminated with mercury.

High risk, FDA, Quality testing problem

Medline Homecare Beds and Hand Pendants

Hand pendants for homecare beds may overheat, causing smoke, sparks, melting, burning, or fire.

High risk, FDA, Device defect

VentStar Resus Neo

VentStar Resus Neo disposable breathing circuit may have cracks in the hose, which could lead to leakage or the hose falling off.

High risk, FDA, Device defect

South Texas Blood & Tissue Center Pooled Platelets and Red Blood Cells

Red blood cells and pooled platelets were collected from a donor who was a resident of a malaria endemic area.

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

Atellica CH Revised C-Reactive Protein (RCRP)

Atellica CH Revised C-Reactive Protein (RCRP) may give falsely elevated results.

Moderate risk, FDA, Device defect

Expressaire and ASP Global Disposable Tourniquet Cuffs

Disposable tourniquet cuffs have an incorrect expiration date, as they are labeled with a 10-year shelf life but the validated shelf life is 5 years.

Moderate risk, FDA, Labeling error

Wright Medical Technology Charlotte Claw Screw

The Charlotte Claw Screw has missing threads on the screwheads, which may prevent secure engagement and lead to surgery prolongation or alternative methods.

Moderate risk, FDA, Device defect

Beckman Coulter Chemistry Analyzer AU480

When this occurs, AlarmDB becomes unreadable and the instrument software cannot be started.

Moderate risk, FDA, Software defect

Karl Storz HOPKINS Telescopes

Hopkins telescopes have an incorrect inside packaging label for the eyepiece.

Moderate risk, FDA, Labeling error

Eversight Illinois Cornea

The cornea was distributed without ensuring the donor was free from risk factors for and clinical evidence of relevant communicable disease agents and diseases.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 100008

Eversight Illinois Cornea

Corneas were distributed when donor eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 100007

Custom Interventional Pain Management Mastisol Skin Adhesive and Continuous Epidural Trays

Mastisol Skin Adhesive has manufacturing issues with the liquid adhesive in surgical trays.

Moderate risk, FDA, Manufacturing problem

Illumina NovaSeq 6000Dx and DRAGEN Server for NextSeq 550Dx

The NovaSeq 6000Dx and Illumina Dragen Server have a security vulnerability.

Moderate risk, FDA, Software defect

Eversight Illinois Cornea

Corneas were recovered from a donor whose eligibility was not adequately determined.

Moderate risk, FDA, Ended, Hospital use, Donor screening problem, FDA event number 100006

13 recalls that day

Apotex Paroxetine Extended-Release Tablets

Apotex Paroxetine Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Cloud Cafe Collagen Milk and Strawberry Milk Zero

Cloud Cafe branded Collagen Milk and Strawberry Milk Zero contain undeclared fish.

Moderate risk, FDA, Undeclared fish