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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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22 recalls that day

Chiesi Curosurf Intratracheal Suspension

Curosurf (poractant alfa) intratracheal suspension lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Mentor Breast Tissue Expanders

Mentor Breast Tissue Expanders may have infusion sets with dull or blunt needle tips that may be difficult to advance and/or break.

Moderate risk, FDA, Device defect

Philips Allura Xper and Azurion Angiography Systems

Allura Xper and Azurion systems may not initiate X-ray imaging or may do so intermittently when using the wired foot switch.

Moderate risk, FDA, Device defect

BD Kiestra ReadA

The BD Kiestra ReadA may have modules unreachable after a reboot, causing delays in plate retrieval.

Moderate risk, FDA, Device defect

Automated Impella Controller (AIC)

The Automated Impella Controller may delay its purge system blocked alarm when used with certain pumps.

High risk, FDA, Device defect

Medline Enfit g-Tube Connector

The Enfit g-Tube Connector and Medline kits containing it may not seal properly, which could lead to leakage.

Moderate risk, FDA, Device defect

Waldemar Link Embrace Drill Towers

The Embrace Drill Tower has mixed-up article numbers in the surgical technique overview.

Moderate risk, FDA, Device defect

Ultradent Jiffy Original Composite Polisher Cups

Jiffy Original Composite Polisher Cups may crumble and break apart easily, which could cause a delay in patient treatment.

Moderate risk, FDA, Device defect

RefleXion X1 Radiotherapy System

A software defect in the RefleXion X1 Radiotherapy System can cause the treatment plan dose to be delivered to the incorrect location.

Moderate risk, FDA, Software defect

Medline Sterile Radiology Procedure Kits

Sterile Radiology Procedure Kits may have a breach in sterile packaging, compromising sterility.

Moderate risk, FDA, Sterility problem

Stryker CHROMOPHARE Softlit Ring Surgical Light System

The surgical light assembly may not adequately support the weight of the ceiling cover.

Moderate risk, FDA, Device defect

ReCor Medical Paradise Ultrasound Renal Denervation Catheters

The Paradise Ultrasound Renal Denervation System catheter is nonconforming and not for human use.

Moderate risk, FDA, Unapproved product

Philips Vue Motion V12

Vue Motion V12 may display image frames out of sequence during dynamic cine runs.

Moderate risk, FDA, Device defect

Puracol and Puracol Plus Collagen Wound Dressings

Puracol and Puracol Plus Collagen Wound Dressings have elevated endotoxin levels, which may cause a strong inflammatory response.

Moderate risk, FDA, Contamination

Atellica CH Enzymatic Hemoglobin A1c (A1c_E)

Atellica CH Enzymatic Hemoglobin A1c may give depressed results when used with another assay on the same analyzer.

Moderate risk, FDA, Device defect

SmartPak Equine Smart & Simple Turmeric Pellets

Turmeric Pellets for horses contain elevated aflatoxin levels.

Moderate risk, FDA, Chemical contamination

American National Red Cross Apheresis Red Blood Cells, Leukocytes Reduced

Apheresis Red Blood Cells, Leukocytes Reduced were distributed without a visual inspection.

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

9 recalls that day

Gear Isle Chocolate Product

Chocolate products contain undeclared sildenafil and tadalafil, which may cause a life-threatening drop in blood pressure.

Not yet rated, FDA

American Laboratories Pepsin Powders

American Laboratories is recalling its Pepsin 1 and Pepsin Full Strength Powder because of potential Salmonella contamination.

Moderate risk, FDA, Ended, Salmonella

Nuts.Com Espresso Malted Milk Balls

Espresso Malted Milk Balls have undeclared wheat and soy allergens.

High risk, FDA, Ended, Undeclared wheat

Philips Respironics Trilogy Evo Ventilators

Using non-pneumatic nebulizers with these ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.

High risk, FDA, Device defect

Merit Medical Hemodialysis Catheters and Sheath Introducer

A design defect may cause the sheath introducer not to split as intended.

High risk, FDA, Device defect

BD Alaris System with Guardrails Suite MX with Point of Care Unit

The labeling does not say which security version hospital networks must enable for secure Wi-Fi communication with Point-of-Care Units.

Moderate risk, FDA, Labeling error

SiluetaYa Mexican Tejocote Roots Supplement Pieces

SiluetaYa Mexican Tejocote Roots Supplement Pieces contain yellow oleander.

High risk, FDA, Chemical contamination

Thermo Fisher Scientific TSCM17, TSCM34 and TSCM48 Laboratory Freezers

The CryoMed Controlled-Rate Freezer may have a heater that can trip a circuit breaker or shock the user.

Moderate risk, FDA, Ended, Device defect

American National Red Cross Cryoprecipitated AHF and Blood Components

Blood products including Cryoprecipitated AHF, PF24 Plasma, and Red Blood Cells may have been prepared with incorrect arm preparation.

Moderate risk, FDA, Ended, Hospital use

5 recalls that day

Lucerne 2% Cottage Cheese

Lucerne 2% Cottage Cheese may contain metal fragments, which could be sharp if broken.

Moderate risk, FDA, Ended, Foreign object

American Health Packaging Meclizine Hydrochloride Tablets

Meclizine Hydrochloride Tablets failed tablet specifications.

Moderate risk, FDA, Quality testing problem

Olympus Cutting Forceps

Defective welds can result in the jaw breaking during clinical use.

Moderate risk, FDA, Device defect

Tandem Pumps

Tandem pumps have a Czech user guide with translation errors that could lead to unintended insulin delivery.

Moderate risk, FDA, Device defect

Ortho-Clinical Diagnostics ORTHO VISION and ORTHO VISION Max Analyzers

Ortho Vision Analyzers and Ortho Vision Max Analyzers have a software anomaly that can cause incorrect association of samples and erroneous patient results.

Moderate risk, FDA, Ended, Software defect

15 recalls that day

SunRidge Farms Organic Beans and Soup Mixes

SunRidge Farms organic black beans, chili bean blend, and sunset soup mix may contain pesticide residue.

Low risk, FDA, Chemical contamination

Amneal Pharmaceuticals Magnesium Sulfate in Water for Injection

Magnesium Sulfate in Water for Injection IV bags may contain Tranexamic Acid instead, which can cause adverse events.

High risk, FDA, Labeling error

Tops Gold Pickles

The pickles may be adulterated with erucic acid from mustard oil ingredient.

Moderate risk, FDA, Chemical contamination

Rose and Shore Margarita Thin Crust Pizza

The 14" Margarita Thin Crust Pizza may contain metal pieces in its tomato ingredient.

Moderate risk, FDA, Ended, Foreign object

South Florida Food Pan de Bono Cheese Bread

Pan de Bono (Cheese Bread) contains undeclared soy.

Moderate risk, FDA, Undeclared soy

Teva Octreotide Acetate for Injectable Suspension

Octreotide Acetate for Injectable Suspension lacks assurance of sterility due to quality system deficiencies at the contract manufacturer.

Moderate risk, FDA, Sterility problem

MacLeods Levothyroxine Sodium Tablets

Levothyroxine Sodium Tablets USP 150 mcg may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

OrthAlign Lantern Knee System Drill Plates

Drill plates are manufactured out of specification.

Moderate risk, FDA, Quality testing problem

Medtronic MiniMed 780G Insulin Pumps

The software defects could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery.

Moderate risk, FDA, Software defect

Straumann Custom Abutments

A material mix-up occurred during manufacturing, and some abutments were made from TAN material instead of titanium.

Moderate risk, FDA, Manufacturing problem

TECNIS Eyhance IOL with TECNIS Simplicity Delivery System

The Tecnis Eyhance IOL may have a haptic that sticks to the optic, preventing the lens from unfolding consistently.

Moderate risk, FDA, Device defect

BiDop 3 Pocket Doppler Blood-Flow Detectors

The BiDop 3 Pocket Doppler has a fetal indication not cleared for use.

Moderate risk, FDA, Unapproved product

Philips Ultrasound Transducers

The notice provides clarification and labelling to define the useful life of ultrasound transducers in the field.

Low risk, FDA, Labeling error

Biomedical Data Solutions Complete Ortho Connect 3.x Software

Complete Ortho Connect 3.x Software has an issue with check rules that could lead to an incorrect result.

Moderate risk, FDA, Ended, Software defect

WellSky Transfusion Blood-Bank Management System

The WellSky Transfusion standalone blood-bank management system can fail to present a required soft-stop alert.

Moderate risk, FDA, Ended, Software defect

2 recalls that day

Bakkavor Basil Pesto Pizza and Roasted Tomato Parmesan Focaccia

Basil Pesto & Mozzarella Pizza and Roasted Tomato Parmesan Focaccia Bread contain metal fragments in the bread.

Moderate risk, FDA, Foreign object

American National Red Cross Blood Components

American National Red Cross Blood Components, collected in a manner that compromises the sterility of the collection system, were distributed.

Moderate risk, FDA, Ended, Hospital use, Sterility problem

1 recall that day

Handy Solutions Neck & Shoulders Heating Pad

The heating pad can cause excessive temperatures when folded or placed under the body, potentially causing burns.

High risk, FDA, Device defect

11 recalls that day

Ajinomoto Frozen Fried Rice and Gyoza Dumplings

Frozen fried rice and dumplings may contain glass.

Moderate risk, FDA, Foreign object