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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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9 recalls that day

ArjoHuntleigh Polska Sp. Z.O.O. Carevo Height-Adjustable Shower Trolley

The Carevo height-adjustable shower trolley can open unintentionally, leading to patient falls and serious injury.

Moderate risk, FDA, Device defect

Stryker Leibinger Precision Pointer Electromagnetic

The Precision Pointer Electromagnetic may fracture during use, and loose parts may fall out while inside the patient.

Moderate risk, FDA, Device defect

Boston Scientific Neuromodulation Nalu Neurostimulation System Therapy Disc and Patient Kit

The Therapy Disc has a firmware issue that causes it to attempt to restart, then fail, becoming non-functional.

Moderate risk, FDA, Software defect

Greer Laboratories Sterile Diluent for Allergenic Extracts Normal Saline

Retention samples from this lot exhibited evidence of glass delamination.

Low risk, FDA, Clinic use

Greer Laboratories Sweet Vernal Grass Pollen

The product has a phenol concentration above the specification limit.

Low risk, FDA, Clinic use

8 recalls that day

Huvepharma Sulmet Soluble Powder

Sulmet Soluble Powder has incorrect expiration dates printed on the primary packaging.

Low risk, FDA, Labeling error

Trifluent Pharma Tridacaine III Lidocaine Patch 5%

The lidocaine patch has incorrect or missing lot and expiration dates.

Not yet rated, FDA, Labeling error

Ridley USA CRYSTALYX HE-20% Cattle and Bison Supplement

Crystalyx HE-20% for beef cattle and bison contains excess non-protein nitrogen and protein.

Not yet rated, FDA

Eagle Pharma Outsourcing Phenylephrine HCl and Oxytocin Infusions

PHENYLephrine HCL Infusion and Oxytocin lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Sunny Sky Non-Dairy French Vanilla Creamer

Sunny Sky Non-Dairy French Vanilla Creamer may have compromised sterility.

Moderate risk, FDA, Sterility problem

Pentax Medical Ultrasound Endoscopes and Water Bottle Assembly

Warnings were added to the instructions for use for ultrasound endoscopes and water bottle assembly.

Moderate risk, FDA, Device defect

Abiomed Impella Controllers

The controller may have an RFID firmware issue causing failure to recognize the purge cassette.

High risk, FDA, Software defect

Greer Laboratories Sterile Diluent for Allergenic Extract

Sterile Diluent for Allergenic Extract, Normal Saline has a lower than expected phenol level.

Low risk, FDA, Clinic use, Quality testing problem

12 recalls that day

Haifa Smoked Fish Cold Smoked Sprats

Cold Smoked Sprats may be contaminated with C. botulinum (botulism), which can cause life-threatening illness.

Not yet rated, FDA

H-E-B Backyard BBQ Chop Salad Kit

The H-E-B Backyard BBQ Chop Salad Kit may contain undeclared soy and tree nuts, posing a risk of serious reaction.

Not yet rated, FDA

Fei Fah Ultra Strentgh Electric Midicated Balm

The product has CGMP deviations.

Moderate risk, FDA, Manufacturing problem

American Regent Cyanocobalamin Injection

Cyanocobalamin Injection contains particulate matter identified as glass.

Moderate risk, FDA, Foreign object

American Red Cross Blood Svcs Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced may have exceeded the acceptable collection volume.

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

We Are Blood Pooled Platelets, Leukocytes Reduced, Irradiated

Pooled Platelets, Leukocytes Reduced, Irradiated were not tested for pH.

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

Medtronic CareLink SmartSync Programmer, Patient Connector and Device Manager App

A software problem may cause an inaccurate displayed longevity estimate.

Moderate risk, FDA, Software defect

ABC Compounding Antiseptic Hand Soaps and Hand and Body Washes

ABC Compounding Antiseptic Hand Soaps and Hand and Body Washes have manufacturing deviations.

Moderate risk, FDA, Manufacturing problem

Philips Azurion 3, 5, and 7 Systems

Philips Azurion systems may have solid-state drives not specified in the Medical Device File, causing loss of imaging or access to images.

Moderate risk, FDA, Device defect

BioMerieux EMAG Nucleic Acid Sample Preparation Instrument

The EMAG system can delay or produce no results when analyzing clinical samples due to a software error.

Moderate risk, FDA, Software defect

Canon Medical System Alphenix Interventional Angiography Systems

The Alphenix interventional angiography system may experience an internal error due to a software issue.

Moderate risk, FDA, Software defect

American National Red Cross Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor deferred for accidental blood exposure.

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

4 recalls that day

ValuHealth Extra Strength Pain Relief Acetaminophen

ValuHealth Extra Strength Pain Relief Acetaminophen 500 mg has an incorrect label on the bottle.

Low risk, FDA, Labeling error

Macleods Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets

Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Philips North America Model 712010

The device can fail immediately after an exposure, causing the system to remain stationary.

Moderate risk, FDA, Device defect

Huons Carboxymethylcellulose Sodium Lubricant Eye Drops

Carboxymethylcellulose Sodium, 0.5% Lubricant Eye Drops may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

2 recalls that day

Tonight We Ride Ultimate Forza Male Supplement

Ultimate Forza Male Supplement contains undeclared sildenafil and tadalafil, which can lower blood pressure to dangerous levels.

Not yet rated, FDA

Neogen Uniprim Powder for Horses

Neogen Uniprim Powder for Horses have a defective container closure.

Moderate risk, FDA, Packaging defect

9 recalls that day

Glenmark Abiraterone Acetate Tablets

Abiraterone Acetate Tablets have a labeling issue.

Moderate risk, FDA, Labeling error

Ritedose Formoterol Fumarate Inhalation Solution

Formoterol Fumarate Inhalation Solution may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

ZestiGreens Broccoli Seeds for Sprouting & Microgreens

Broccoli seeds may be contaminated with Salmonella.

High risk, FDA, Salmonella

Safecor Health Metoclopramide Tablets

Teva Pharmaceuticals Metoclopramide Tablets, USP, 5 mg, 100 Tablets per bottle may be mixed with a different tablet.

Moderate risk, FDA, Foreign object

Ziehm-Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System

The Orthoscan VERSA Accessory Cart and Versa Mini C-Arm System have a weld that may fail, causing the monitor arm to separate.

Moderate risk, FDA, Device defect

Medtronic OmniaSecure Model 3930M Leads

The OmniaSecure Model 3930M lead may have difficulty achieving fixation during implantation, potentially causing tissue trauma.

Moderate risk, FDA, Device defect

Blue Bottle Coffee Sweet Blossom Simple Syrup

Blue Bottle Coffee Sweet Blossom Simple Syrup may be contaminated with mold.

Moderate risk, FDA, Contamination

Ethicon Ethilon Nylon Suture

Ethilon Nylon Suture may have needles with distorted curvature that may break during use, causing additional soft tissue or vessel injury.

Moderate risk, FDA, Device defect

Miyoko's Creamery European Style Salted Plant Milk Butter

Miyoko's Creamery European Style Salted Plant Milk Butter may contain yeast, mold, and E. coli.

Moderate risk, FDA, E. coli

16 recalls that day

WinCo Foods Hoagie Rolls

WinCo Foods Hoagie Rolls contain undeclared sesame, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared sesame

Natural Grocers Brand Organic 2 Pound Mung Beans

Natural Grocers Brand Organic Mung Beans may contain glass, which can cause injury if ingested.

Not yet rated, FDA

Strides Pharma Cinacalcet Tablets

Strides Pharma Cinacalcet Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

AvKARE Amitriptyline Hydrochloride Tablets

Avkare Amitriptyline Hydrochloride Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Halyard Anterior Hip Packs

Halyard Anterior Hip Pack may contain a non-sterile component placed outside the sterile barrier.

Moderate risk, FDA, Sterility problem

Medline C-Section Drapes and Medical Convenience Kits

Medline drape and convenience kits are difficult to remove from patients and leave adhesive residue on skin.

Moderate risk, FDA, Device defect

Solstice Xact Mole Marker for Mammography

The Xact mole marker for mammography may have its radiopaque material detach, causing artifact in some cases.

Moderate risk, FDA, Device defect

Medtronic Neuromodulation InterStim SureScan MRI Leads and Percutaneous Extensions

InterStim SureScan MRI Leads may be used with the wrong lead or extension, preventing the system from working as intended.

Moderate risk, FDA, Device defect

Medtronic MiniMed Go App

The MiniMed Go app has a software defect that can cause missed or delayed insulin doses, potentially leading to hyperglycemia or hypoglycemia.

Moderate risk, FDA, Software defect

restor3d MTP Implants

The restor3d MTP Implant may not have been sterilized, as indicated by orange sterilization indicators.

Moderate risk, FDA, Device defect