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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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15 recalls that day

Eridanous Greek Style Shortbread Cookies

Eridanous Greek Style Shortbread Cookies contain undeclared milk, egg, tree nut, wheat, and soy.

Moderate risk, FDA, Undeclared milk

Micro Labs Dorzolamide HCl and Timolol Maleate Ophthalmic Solution

Dorzolamide HCl and Timolol Maleate Ophthalmic Solution has defective container with broken cap spikes and undeliverable drops.

Moderate risk, FDA, Packaging defect

Proin ER, Phenylpropanolamine Hydrochloride Extended-Release Tablets

Proin ER, phenylpropanolamine hydrochloride extended-release tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Ascend Laboratories Dabigatran Etexilate Capsules

Dabigatran Etexilate Capsules may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Man Fon Wonton Wrappers

Man Fon Wonton Wrappers have undeclared colors Yellow#5 and Yellow#6.

Moderate risk, FDA, Ended, Undeclared wheat

Mylan Mycophenolate Mofetil for Injection

Mycophenolate Mofetil for Injection USP contains a precipitate.

Moderate risk, FDA, Quality problem

Argon Medical Devices L-Cath Catheters

Argon Medical Devices L-Cath Catheters may leak or crack at the hub, leading to blood loss and infection.

Moderate risk, FDA, Device defect

AMS Aligned Medical Solutions Surgical Procedure Packs

AMS Aligned Medical Solutions medical convenience kits may have unexpected variability of endotoxin levels.

Moderate risk, FDA, Sterility problem

Permobil M5 Corpus Power Wheelchair

The M5 Corpus Power Wheelchair may drive under restricted conditions and create an unstable condition.

Moderate risk, FDA, Software defect

Permobil M3 Corpus Power Wheelchair

The Permobil M3 Corpus Power Wheelchair may tip over or cause falls when the seat lift exceeds 50 mm.

Moderate risk, FDA, Software defect

The Blood Center Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced, which were labeled as leukocytes reduced but failed the monthly QC residual white blood cell count, were distributed.

Moderate risk, FDA, Ended, Hospital use, Labeling error

Octapharma Octagam Immune Globulin (Human)

There is the potential for damaged units being on the US market.

Moderate risk, FDA, Hospital use

9 recalls that day

Fresenius Kabi Glycopyrrolate, Lidocaine and Naropin Injections

Glycopyrrolate Injection, Lidocaine HCl Injection, Naropin, and Xylocaine contain hair.

Moderate risk, FDA, Foreign object

Rohto Cooling Eye Drops

Rohto Cooling Eye Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Precision Dose Glycopyrrolate Oral Solution

Glycopyrrolate Oral Solution may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Medline Medical Convenience Kits

Medline medical convenience kits may be contaminated with low levels of Bacillus species.

Moderate risk, FDA, Contamination

Medline Convenience Kits Containing Bard Silastic Foley Catheters

Medline convenience kits containing Bard Silastic Foley Catheters may have increased raw material on the surface, which may be harmful.

Moderate risk, FDA, Device defect

Medline Hip and Knee Procedure Kits

The procedure kits contain ICU Medical, Inc. pain management kits containing Bupivacaine Hydrochloride in Dextrose Injection, USP.

High risk, FDA, Device defect

MiniMed Go App

The MiniMed Go App may not trigger nighttime alerts, leading to missed insulin doses and increased hyperglycemia risk.

Moderate risk, FDA, Software defect

Karl Storz Endoscopy Flexible Hystero-Fiberscope Kits

Flexible Hystero-Fiberscope Kits may contain an expired seal, impacting sterility assurance.

Moderate risk, FDA, Sterility problem

SafeOp Patient Interface

The device may experience loss or interruption of triggered electromyography (tEMG) functionality during use.

Moderate risk, FDA, Software defect

9 recalls that day

Kroger and Simple Truth Chicken Eggs

Kroger and Simple Truth Chicken Eggs may be contaminated with Salmonella Enteritidis, which can cause serious infections.

High risk, FDA, Ended, Salmonella

SnapshotGLO Wound Imaging Device

The SnapshotGLO Wound Imaging Device may not resume charging after a battery fully discharges, becoming temporarily unusable.

Moderate risk, FDA, Software defect

Pipeline Flex Embolization Device with Shield Technology

Pipeline Flex Embolization Device with Shield Technology is mislabeled, with 12 mm and 20 mm implants swapped.

Moderate risk, FDA, Labeling error

Medline Convenience Kits

The kits contain Bupivacaine Hydrochloride in Dextrose Injection, which has quality issues.

High risk, FDA, Device defect

Halyard Standard Line Insertion Pack

The Halyard Standard Line Insertion Pack has defective silicone seals that may cause fluid occlusion or leakage.

Moderate risk, FDA, Device defect

Emano Flow

The problem usually over-reports flow rate and volume; the firm have made corrected results available to care teams.

Moderate risk, FDA, Device defect

Boston Scientific TheraSphere 360 Y-90 Management Platform

A software anomaly occurs when a user adds vials to the cart and then modifies an input.

Moderate risk, FDA, Software defect

Olympus High Flow Insufflation Unit - UHI-4

The front panel display can turn off unexpectedly, and air delivery ceases.

Moderate risk, FDA, Device defect

AXP Processing Bag Set

AXP Processing Bag Set may release particulates into the sterile fluid path.

Moderate risk, FDA, Ended, Foreign object

10 recalls that day

Pumpkin Tree Peter Rabbit Organics Banana & Strawberry Fruit Puree

Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree may contain thin, soft plastic strands.

Moderate risk, FDA, Foreign object

MG Foods Spicy Breakfast Burritos

Spicy Breakfast Burritos may contain undeclared soy, posing a risk of serious allergic reaction.

High risk, FDA, Undeclared soy

Green Jeeva Organic Moringa Powder

Organic Moringa Powder is positive for salmonella.

High risk, FDA, Salmonella

Brooklyn Roasting Company Pasteurized Cold Brew Concentrate

Pasteurized cold brew concentrate may lead to C. botulinum (botulism) toxin formation.

Moderate risk, FDA, Ended, Botulism

Medtronic Neurosurgery Ventriculostomy Kit

Ventriculostomy kits may have endotoxin levels above the acceptable limit, causing an acute inflammatory process.

Moderate risk, FDA, Contamination

Island Pacific and Nautilus Imitation Crab Sticks and Flakes

Imitation crab sticks and flakes contain undeclared sodium tripolyphosphate.

Low risk, FDA, Undeclared color or additive

Penumbra System RED 68 Reperfusion Catheter

The Penumbra System RED 68 Reperfusion Catheter may fracture due to manufacturing issues.

Moderate risk, FDA, Manufacturing problem

Wilcox BOSS Xe Family

The BOSS Xe family has a software enhancement to increase safety.

Moderate risk, FDA, Software defect

3mensio Workstation (Vascular Fenestrated) Software

The 3mensio Workstation software may report user measurements larger than actual anatomical dimensions.

Moderate risk, FDA, Software defect

Silent Nite Sleep Appliance

The Silent Nite Sleep Appliance lacks FDA clearance.

Moderate risk, FDA, Unapproved product

8 recalls that day

Enovachem Pharmaceuticals Lidolog Kit

The Lidolog Kit has a label that covers the barcode, making it hard to scan.

Low risk, FDA, Labeling error

Olympus 4K UHD LCD Monitor

The Olympus 4K UHD LCD Monitor can have faulty HDMI and DisplayPort connectors, causing image loss or abnormalities.

Moderate risk, FDA, Device defect

Boston Scientific FARADRIVE Steerable Sheath Clear

Boston Scientific Faradrive Steerable Sheath Clear may have valve damage that can cause air ingress and potential air embolism.

Moderate risk, FDA, Device defect

Halyard Eye Pack Convenience Kit

The Halyard Eye Pack Convenience kit contains an incorrect concentration of Betadine solution.

Moderate risk, FDA, Device defect

SeaSpine Polyaxial Head

Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.

Moderate risk, FDA, Manufacturing problem

We Are Blood Red Blood Cells and Pooled Cryoprecipitated AHF

Red Blood Cells and Pooled Cryoprecipitated AHF were collected from a donor who had permanent make-up applied within three months of donation.

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

The Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced were collected from a donor not tested for Chagas.

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

Blood Connection Red Blood Cells, Leukocytes Reduced

Red Blood Cells, Leukocytes Reduced lack proper documentation of antigen typing.

Moderate risk, FDA, Ended, Hospital use

1 recall that day

Zen Principle Naturals Moringa Leaf Powder Dietary Supplement

Zen Principle Naturals Moringa Leaf Powder dietary supplement may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Salmonella

1 recall that day

Rising Pharma Cetirizine Hydrochloride Tablets

Cetirizine Hydrochloride Tablets USP 5 mg may be contaminated with ranitidine, which can cause serious adverse events.

High risk, FDA, Contamination