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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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8 recalls that day

Teva Metoprolol Succinate Extended-Release Tablets

Teva Pharmaceuticals Metoprolol Succinate Extended-Release Tablets may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Impella RP

Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.

High risk, FDA, Device defect

Cobas Pro Integrated Solutions with Cobas C 503 analytical Units

The cobas pro integrated solutions with cobas c 503 analytical units have a software defect that can cause erroneous patient results.

Moderate risk, FDA, Software defect

GE Healthcare Centricity Universal Viewer Zero Footprint Client

Patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client.

Moderate risk, FDA, Device defect

Olympus ShockPulse-SE Lithotripsy System Reusable Probes, Single Use Probes and Generator

The device can remain in a blinking phase waiting to recognize the transducer.

Moderate risk, FDA, Device defect

4 recalls that day

Valley Springs Artesian Gold Bottled Water and Distilled Water

Water was bottled under insanitary conditions.

Moderate risk, FDA, Contamination

Medtronic Perfusion Systems Octopus Nuvo Tissue Stabilizer

The Octopus Nuvo Tissue Stabilizer has an assembly issue where tubing was incorrectly positioned.

Moderate risk, FDA, Manufacturing problem

Remel Campy CVA Medium

Customer complaints report low to no recovery of Campylobacter Jejuni on the identified lot.

Moderate risk, FDA, Device defect

Agiliti Health - Ellis Adapt Pump

The Adapt Pump does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes.

Moderate risk, FDA, Device defect

4 recalls that day

Lockout Industries Boner Bears Chocolate Syrup

Boner Bears Chocolate Syrup contains undeclared sildenafil, which may lower blood pressure to dangerous levels.

High risk, FDA, Hidden drug ingredient

Agebox iKids-Growth Day and Night Formula Capsules

Agebox iKids-Growth (Day Formula) capsules contain undeclared ibutamoren.

Moderate risk, FDA, Hidden drug ingredient

Wizcure Pharmaa Eye Drops and Fluorescein Sodium Ophthalmic Strips

Several eye products, including Vista Tears, Vista Gel, Vista Meibo Tears, Vista Gonio, CHNaO, Bio Glo, and BioGlo, lack assurance of sterility.

Moderate risk, FDA, Sterility problem

SB Food Yoyo Gummy Assorted, Tropical and Grape Plus Flavors

SB Food Yoyo Gummy Assorted, Tropical and Grape Plus Flavors contain an unallowed color Carmoisine (E122).

Moderate risk, FDA, Undeclared color or additive

9 recalls that day

Clover Sonoma and Great Value Cottage Cheese and Sour Cream

Clover Sonoma and Great Value Cottage Cheese and Sour Cream may be under pasteurized and could pose a health risk.

Moderate risk, FDA, Ended, Processing problem

Elite Treats All Natural Chicken Chips for Dogs

All Natural Chicken Chips for Dogs may be contaminated with Salmonella, which can cause illness in pets and serious infections in people.

High risk, FDA, Ended, Salmonella

Tiki Bar Candy Dark Chocolatey Peanut Butter & Pretzel

The candy bar lists peanut in ingredients but not in the Contains statement.

Moderate risk, FDA, Ended, Undeclared peanut

Willamette Valley Fruit Company IQF Blueberry

IQF Blueberry may contain Listeria.

High risk, FDA, Ended, Listeria

Lubna Quality Products Mung Beans

Mung Beans contain the pesticide thiamethoxam.

Low risk, FDA, Ended, Chemical contamination

Medline Kits with Tego Connectors

Medline Kits with Tego Connectors may have silicone seal issues that can cause fluid leakage or air infusion.

Moderate risk, FDA, Contamination

Encore Medical Reverse Shoulder Prosthesis and EMPOWR 3D Knee Inserts

Knee and humeral socket implants contain incorrect labeling.

Moderate risk, FDA, Labeling error

PIE PAK and Trolley System

Edermy is recalling its Pie Pak and PIE Trolley System because of the lack of 510K clearance.

Moderate risk, FDA, Unapproved product

Tengen USA Trading YO!MAN Cucumber and Lettuce

Tengen is recalling its Yo!Man Cucumber and Yo!Man Lettuce because they contain undeclared cyclamates.

Low risk, FDA, Ended, Undeclared color or additive

3 recalls that day

Slate Run Eptifibatide Injection

The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing.

Low risk, FDA, Labeling error

AvKARE Amantadine HCl Capsules

The capsules failed dissolution specifications.

Moderate risk, FDA, Drug dissolving problem

Adbry (Tralokinumab-Ldrm) Injection

Adbry injection may lack sterility assurance due to particulate matter identified as wool fiber.

Moderate risk, FDA, Sterility problem

6 recalls that day

Made Fresh Salads Cream Cheese and Tofu Whipped

Made Fresh Salads Cream Cheese and Tofu Whipped may be contaminated with Listeria.

High risk, FDA, Ended, Listeria

Medline Sterile Saline Wound Wash and Convenience Kits

Medline Sterile Saline Wound Wash, Medline Convenience Kits, and Meijer Sterile saline wound wash may not meet sterility requirements.

Moderate risk, FDA, Sterility problem

Hitachi Proton Beam Therapy

Hitachi Proton Beam Therapy may result in positional discrepancy.

Moderate risk, FDA, Software defect

MRIMed MRI LED Mobile Exam Light Battery

Due to battery component overheating while charging resulting in melting of internal components and causing smoke.

Moderate risk, FDA, Device defect

Olympus Resection and Inner Sheaths

Olympus Resection and Inner Sheaths can break at the ceramic tip.

Moderate risk, FDA, Device defect

Olympus Cystoscope Outer Sheath

The Olympus Cystoscope Outer Sheath is being removed due to incompatibility with a GreenLight Laser that could damage the device tip.

Moderate risk, FDA, Device defect

1 recall that day

Molly Kitchen's Tuna Salad

Tuna Salad is mislabeled as Chicken Salad, containing undeclared fish allergen.

High risk, FDA, Ended, Undeclared fish

3 recalls that day

H & N Group Frozen Cooked Medium Shrimp

Frozen cooked shrimp may be contaminated with Cesium-137 due to insanitary conditions.

Moderate risk, FDA, Ended, Chemical contamination

Olympus High Flow Insufflation Unit

The Olympus High Flow Insufflation Unit has a software algorithm issue that may lead to overpressure events.

High risk, FDA, Software defect

Intuitive Surgical Da Vinci 5 Console

The Da Vinci 5 surgical system can have an error event that causes loss of user interface content on a monitor.

Moderate risk, FDA, Software defect

8 recalls that day

Steves Real Food Quest Cat Food

Quest Cat Food Chicken Freeze Dried Nuggets may have inadequate thiamine levels, which can cause neurological signs in cats.

High risk, FDA, Ended, Wrong nutrient levels

Woodland Gourmet Arrowroot Flour

Woodland Gourmet Arrowroot Flour may contain foreign material.

Moderate risk, FDA, Ended, Foreign object

Medline Convenience Kits and Surgical Drapes

Medline Convenience Kits and Surgical Drapes may not be sterile due to calibration issues in sterilization equipment.

Moderate risk, FDA, Sterility problem

Auris Health MONARCH Bronchoscopy Platform

The Monarch Platform, a bronchoscopy device, has a software issue that may cause unanticipated robotic arm positioning toward patient-left.

Moderate risk, FDA, Software defect

Stryker MOLLI 2 System, Introducers, Wand, OncoPen and Tablet

The Molli 2 System has labeling that needs updating because magnetized surgical tools can dislodge markers.

Moderate risk, FDA, Labeling error

Indian Kitchen Mart Aluminum Saucepan, Brass Tope, Aluminum Kadai and Brass Pital Pot

IKM Aluminum Saucepan, Brass Tope, Aluminum Kadai, and Brass Pital Pot may contain leachable lead.

High risk, FDA, Contamination

Olympus Thunderbeat Surgical Devices

The firm is initiating a removal due to continued reports of adverse events.

Moderate risk, FDA, Device defect

Centinel Spine Prodisc C SK Total Cervical Disc Replacement

Prodisc C SK total cervical disc replacement was mislabeled as the 6mm product but included the 5 mm product.

Moderate risk, FDA, Labeling error

13 recalls that day

Tippy Toes Apple Pear Banana Baby Food

Tippy Toes apple pear banana baby food may be contaminated with patulin, which can cause health issues.

Moderate risk, FDA, Chemical contamination

Shaman Botanicals White Vein Advanced Alkaloids Chewable Tablets

Alkaloids Chewable Tablets—White Vein contain more 7-Hydroxymitragynine than labeled, which could cause adverse health effects.

High risk, FDA, Labeling error

Rosabella Brand Moringa Dietary Supplement Capsules

Rosabella Moringa capsules may be contaminated with Salmonella, which can cause serious infections.

High risk, FDA, Ended, Salmonella

Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset

The liquid dietary supplement declares bovine colostrum but does not declare milk allergen.

Moderate risk, FDA, Ended, Undeclared milk

MediHoney Gel and Calcium Alginate Dressings

Potential packaging failures, which could lead to a breach in the sterile barrier.

Moderate risk, FDA, Sterility problem

Spectrum IQ Infusion Pump

The Spectrum IQ Infusion Pump was released without full testing, including occlusion alarm testing.

Moderate risk, FDA, Device defect

Wilson-Cook Teslatome Bipolar Sphincterotomes

Teslatome Bipolar Sphincterotomes may have a void separating wire guide and cutting wire lumens, causing inappropriate current path.

Moderate risk, FDA, Device defect