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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

Beckman Coulter Mishima Chemistry Analyzers AU5800 and DxC 700 AU

Beckman Coulter Mishima K.K is recalling its Chemistry Analyzer AU5800 and DxC 700 AU because a delay in results may occur.

Moderate risk, FDA, Software defect

HealthCast "Vital Sync" Remote Patient Monitoring System

The system may not transmit or receive alarms from the primary patient bedside monitor.

Moderate risk, FDA, Device defect

EndoVive Safety PEG Kit

EndoVive Safety PEG Kit may have open or compromised seals on sterile swabstick packaging.

Moderate risk, FDA, Sterility problem

Young Again Pet Food Core Health Dog Food

Dog food tested presumptive Salmonella positive.

High risk, FDA, Salmonella

8 recalls that day

Lowes Foods Sour Cream and Onion Flavored Potato Chips

Lowes Foods sour cream and onion flavored potato chips have inaccurate nutritional data and undeclared ingredients.

Moderate risk, FDA, Ended, Wrong nutrient levels

Willamette Valley Pie Blueberry Crumble Pies

Frozen raw blueberry crumble pies may be contaminated with Listeria.

Moderate risk, FDA, Ended, Listeria

Hortex Spring Vegetable Mix

The spring vegetable mix may contain glass.

Moderate risk, FDA, Ended, Contamination

Waldemar Link Endo-Model Replacement Plateaus and Connection Components

The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Moderate risk, FDA, Device defect

GEM Premier 5000

GEM Premier 5000 may experience increased errors during warm-up, leading to ejection and delayed results.

Moderate risk, FDA, Device defect

Physio-Control Infant/Child Reduced Energy Defibrillation Electrodes

Infant/Child Reduced Energy Defibrillator Electrodes can delaminate.

Moderate risk, FDA, Device defect

Medartis APTUS TriLock Screws

APTUS TriLock Screws may be mixed up between specified lots of 2.5mm and 2.8mm outer diameter screws.

Moderate risk, FDA, Device defect

Huvepharma BioCox 60 Type A Medicated Article

The product failed to meet stability specification requirements for assay at the 6M and 9M timepoints.

Moderate risk, FDA, Quality testing problem

3 recalls that day

Vegetarian Chicken Flavor Ramen Express

Vegetarian chicken flavor ramen contains undeclared Yellow #5.

Moderate risk, FDA, Undeclared color or additive

Exactech Equinoxe Ergo and Equinoxe Core Instrument Kits

The Equinoxe Core Instrument Kit and Ergo Modular Impactor Handle may have a missing cross-pin in the impactor handle.

Moderate risk, FDA, Device defect

Penner Pacific Bathing Spas

The Penner Pacific Bathing Spa lacks a unique device identifier.

Low risk, FDA, Device defect

5 recalls that day

C2O Coconut Water with Pulp

C2O Coconut Water with Pulp has an incorrect Nutrition Facts Panel and Ingredient List on the outer box.

Low risk, FDA, Ended, Labeling error

Raz Mobile Shower Commode Chairs

These mobile shower commode chairs may have rear seat brackets that are not properly engaged.

Moderate risk, FDA, Device defect

Medline Unna-Z Stretch Zinc Paste Bandage

Medline Unna-Z Stretch Zinc Paste Bandage has a labeling error with incomplete ingredients listed.

Moderate risk, FDA, Labeling error

BD 10mL Luer-Lok Tip Syringes

Some Luer Slip syringes were incorrectly included in a batch of Luer Lok syringes.

Moderate risk, FDA, Device defect

IBA Proton Therapy System - PROTEUS 235

The IBA Proton Therapy System has a disabled beam triggering interface, which may lead to mistreatment when external gating devices are used.

Moderate risk, FDA, Device defect

7 recalls that day

Funaros Perfect Pasta Lobster & Crab Ravioli

Lobster & Crab Ravioli contains undeclared shrimp, crab, lobster, pollock, whiting, and soy.

High risk, FDA, Ended, Undeclared soy

Nomida Semaglutide and Tirzepatide Injections

Semaglutide and tirzepatide sterile multi-dose vials lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Radnostix Sodium Iodide I-131 Oral Solution

Sodium Iodide (I-131) Solution contains particulate matter due to production issues.

Moderate risk, FDA, Foreign object

Olympus ShockPulse-SE Lithotripsy System with Generator

The Olympus ShockPulse-SE Lithotripsy System has a mis-wired component that can cause noise and delay treatment.

Moderate risk, FDA, Device defect

Mohamed Hagar Mojo Max Fusion XXX Capsules

Mojo Max Fusion XXX contains undeclared sildenafil and tadalafil.

High risk, FDA, Hidden drug ingredient

Advanced Bionics HiResolution Bionic Ear System Sky CI M90 Sound Processor

The Sky CI M90 Sound Processor has a packaging label that differs from the included product.

Moderate risk, FDA, Labeling error

MR. 7 Super 700000 Capsules

The product is marketed without an approved NDA/Anda.

High risk, FDA, Hidden drug ingredient

6 recalls that day

Vergani 1944 Milano Pandoro Classico Gluten Free

The gluten-free pandoro may contain Teflon fragments from flaking cooking molds.

Moderate risk, FDA, Ended, Contamination

Karns Foods Mini Dark Chocolate Raspberry Cups

Mini Dark Chocolate Raspberry Cups may contain undeclared peanuts, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared peanut

Rising Pharmaceuticals Temozolomide Capsules, 5mg

Rising Pharmaceuticals Temozolomide Capsules, 5mg may contain more impurities than allowed.

Moderate risk, FDA, Drug impurity

Dermal Source Five-Star Vasocaine Spray and Maximum Zone Lidocaine Creams

Five-Star Vasocaine Spray and Maximum Zone 1 and Zone 2 Lidocaine Creams have stability data that does not support their expiry dates.

Moderate risk, FDA, Quality testing problem

Mylan Amnesteem Isotretinoin Capsules

Amnesteem (Isotretinoin) Capsules, USP 40 mg may not dissolve properly in the body.

Moderate risk, FDA, Drug dissolving problem

Vascutek Gelsoft Plus and Gelweave Vascular Grafts

Gelatin sealed woven polyester prostheses devices were incorrectly labeled with an additional month of shelf life.

Moderate risk, FDA, Labeling error

8 recalls that day

Miss Vickies Spicy Dill Pickle

Miss Vickies Spicy Dill Pickle Potato Chips may contain undeclared milk, posing a risk of serious allergic reaction.

High risk, FDA, Ended, Undeclared milk

Premium Food Bubble Gum and Jordan Almonds

Premium Food Jordan Almonds contain undeclared wheat and colors, and Premium Food Bubble Gum contains undeclared colors.

Moderate risk, FDA, Undeclared wheat

Cipla Nilotinib Capsules

The capsules failed a test for appearance after six months.

Low risk, FDA, Quality testing problem

Major Pharmaceuticals Midodrine Hydrochloride Tablets

Midodrine Hydrochloride Tablets have a defective container with inadequately sealed blister packaging.

Moderate risk, FDA, Packaging defect

Olympus Single Use Biopsy Valve

The Olympus Single use Biopsy Valve may have rubber fragment detachment during use.

Moderate risk, FDA, Foreign object

Datascope CS100 and CS300 Intra-Aortic Balloon Pumps

The battery runtime and cycle specifications in the instructions for use need to be updated.

Moderate risk, FDA, Device defect

STA Liatest Free Protein S

STA Liatest Free Protein S kits can give out-of-range results and underestimate free protein S levels in normal plasma.

Moderate risk, FDA, Device defect

Esaote Endocavity Ultrasonic Probe E 3-12

The Esaote Endocavity ultrasonic probe may leak liquid from its casing near the cable.

Moderate risk, FDA, Device defect

6 recalls that day

Acme United BZK Antiseptic Towelettes and Hand Sanitizing Wipes

Acme United BZK Antiseptic Towelettes and Hand Sanitizing Wipes have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

Harbin Jixianglong Biotech Semaglutide

Semaglutide was distributed before process validation and bacterial endotoxin method validation were completed.

Moderate risk, FDA, Manufacturing problem

B. Braun 21G Winged Infusion Sets

The needle tip may be dull or blunt, difficult to advance, or break.

Moderate risk, FDA, Device defect

Staar Surgical EVO+ Visian Toric Implantable Collamer Lens (TICL)

The EVO+ Visian Toric Implantable Collamer Lens is labeled as 12.1 mm but is 12.6 mm, which may cause excessive vault and patient discomfort.

Moderate risk, FDA, Labeling error

Aesculap MINOP Trocar

The Minop Trocar 150MM 4 Wking CHANNEL6.0MM has a trocar shaft that may be too long.

Moderate risk, FDA, Device defect

Atellica CH Urine Albumin (UAlb)

Atellica CH Urine Albumin (UAlb) may report falsely depressed patient results.

Moderate risk, FDA, Device defect

8 recalls that day

Primal Herbs Volume Herbal Supplement

Primal Herbs Volume herbal supplement contains undeclared sildenafil, which may lower blood pressure to dangerous levels.

High risk, FDA, Hidden drug ingredient

Savannah Bee Company Honey BBQ Sauce Mustard

Honey BBQ Sauce Mustard may contain undeclared wheat and soy, posing a risk of serious allergic reaction.

Moderate risk, FDA, Ended, Undeclared wheat

Rhino Choco VIP 10X Chocolate

Rhino Choco VIP 10X Chocolate contains undeclared Tadalafil, which may lower blood pressure to dangerous levels.

Not yet rated, FDA