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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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16 recalls that day

Terumo BCT Rika Plasma Donation System

The Rika Plasma Donation System has a potential safety issue with an electrical component in its control valve.

Moderate risk, FDA, Ended, Device defect

9 recalls that day

...And Kimchi Branded Kimchi

Kimchi contains undeclared fish, which can cause serious allergic reactions in people with fish allergies.

Moderate risk, FDA, Ended, Undeclared fish

Utz Quality Foods: Zapp's and Dirty Potato Chips

Utz is recalling Zapp's and Dirty potato chips in several varieties for possible Salmonella contamination.

High risk, FDA, Ended, Salmonella

Fresenius Medical Care Delflex Peritoneal Dialysis Solution

Delflex, Dextrose Peritoneal Dialysis Solution with attached stay-safe Exchange Set may leak from perforations in bags, lacking assurance of sterility.

Moderate risk, FDA, Sterility problem

Ajanta Pharma Duloxetine Delayed-Release Capsules

Duloxetine Delayed-Release Capsules contain an impurity above the FDA recommended limit.

Moderate risk, FDA, Drug impurity

Harrow Eye FreshKote Lubricant Eye Drops

Freshkote Lubricant Eyedrops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

Griffith Foods Meatloaf Seasoning, Milk Wash and Milk-N-Egg Mix

Milk wash, meatloaf seasoning, and milk-n-egg mix may be contaminated with Salmonella.

High risk, FDA, Salmonella

Sungel XZL Jelly Snacks

Jelly snacks contain undeclared FD&C Yellow #5 & #6 and Red #40.

Moderate risk, FDA, Ended, Undeclared color or additive

Disaronno Ingredients Montebianco Base Vegan

Montebianco Base Vegan contains undeclared milk allergen.

Moderate risk, FDA, Ended, Undeclared milk

Physio-Control LIFEPAK 15

Some defibrillators were serviced without a Performance Inspection Procedure.

Moderate risk, FDA, Device defect

1 recall that day

A2 Platinum Premium Infant Formula Milk-Based Powder with Iron

A2 Platinum Premium infant formula may be contaminated with cereulide toxin, which can cause gastrointestinal illness in infants.

High risk, FDA, Ended, Contamination

12 recalls that day

Second Nature Keto Crunch Smart Mix

Second Nature Keto Crunch Smart Mix may contain undeclared cashews, pistachios, and cherries, posing a risk of serious allergic reactions.

Moderate risk, FDA, Ended, Undeclared tree nut

Unichem busPIRone Hydrochloride Tablets

BusPIRone Hydrochloride Tablets, USP, 5 mg may be weaker than labeled.

Low risk, FDA, Wrong drug strength

Spacelabs Ultraview SL Command Module

The Spacelabs Ultraview SL Command Module has a manufacturing issue due to a malfunctioning electrical leakage tester.

Moderate risk, FDA, Manufacturing problem

Centinel Spine Prodisc C SK Total Cervical Disc Replacements

Prodisc C SK U.S. implants have a labeling mix-up, with 5mm and 6mm sizes mislabeled.

Moderate risk, FDA, Labeling error

Halyard Cardiac Cath and Cath Lab Kits

The syringe rotating adaptor may unwind during use.

High risk, FDA, Device defect

Cook Centimeter Sizing Catheters

Marker bands may be at an increased risk of cracking/breakage.

High risk, FDA, Device defect

Boston Scientific LUX-Dx II Arrhythmia Detectors and Alarms

LUX-DX II and LUX-Dx II Plus Arrythmia detectors and alarms may not collect PVC Burden data or monitor for Bradyarrhythmia and Pause.

Moderate risk, FDA, Software defect

Erbe ERBEFLO CleverCap CO2 Tubing and Cap Sets

Erbeflo CleverCap CO2 and other tubing/cap sets for endoscopes may allow unintended water flow, leading to water aspiration and respiratory failure.

Moderate risk, FDA, Device defect

Da Vinci X, Xi Surgical System

The da Vinci X and Xi Surgical Systems have screws in the arm sub-assembly that may be susceptible to breaking.

Moderate risk, FDA, Device defect

VOCSN V+Pro Package

The Vocsn V+Pro respiratory system may leak oxygen, reducing inspired oxygen and increasing fire risk.

High risk, FDA, Device defect

Intuitive 8 mm SureForm 30 Gray Reloads

Intuitive 8 mm SureForm 30 Gray Reloads may produce an incomplete staple line.

High risk, FDA, Device defect

GELLEN Time to Shine Nail Removal Kit

The nail removal kit contains methylene chloride and chloroform.

Moderate risk, FDA, Chemical contamination

6 recalls that day

My Mochi Strawberry Flavored Non-Dairy Frozen Dessert

My Mochi Strawberry flavored Non-Dairy Frozen Dessert contains a foreign object.

Moderate risk, FDA, Ended, Foreign object

Calypso Tropic Tango Lemonade

Calypso Tropic Tango Lemonade contains undeclared Yellow No. 5.

Moderate risk, FDA, Ended, Undeclared color or additive

Ganesha Enterprises KLG Kesar Mukhwas

KLG Kesar Mukhwas contains undeclared food colorings and an unapproved color additive.

Moderate risk, FDA, Ended, Undeclared color or additive

CVS Pharmacy Lidocaine Wound Gel

Water-Jel Technologies is recalling its Lidocaine Wound Gel because failed PH specifications.

Low risk, FDA, Quality testing problem

Medline and Centurion Medical Convenience Kits

Medical convenience kits containing Webcol Large Alcohol Prep Pads may be non-sterile due to a contaminant.

Moderate risk, FDA, Sterility problem

Medline Neuro Sponges

Medline Neuro Sponges may have higher-than-expected endotoxin levels.

Moderate risk, FDA, Quality testing problem

13 recalls that day

Pork King Good Onion & Sour Cream Seasoning

Pork King Good Onion & Sour Cream Seasoning may be contaminated with Salmonella.

High risk, FDA, Salmonella

Hikma Pharmaceuticals Alendronate Sodium Oral Solution

Some bottles of Alendronate Sodium Oral Solution have out of specification assay results.

Moderate risk, FDA, Quality testing problem

North American Rescue AIDBAG First Aid Kits

AIDBAGs first aid kits contain a blood glucose system that can show an error code, delaying treatment.

High risk, FDA, Software defect

Immuno-Mycologics Myco DDR Trident Neutralization Buffer B

Neutralization Buffer may contain contaminants.

Moderate risk, FDA, Contamination

Depuy Synthes Attune Revision Hinge Femoral

The external sterile packaging was found adhered to the internal sterile packaging.

Moderate risk, FDA, Sterility problem

Siemens Epoc BGEM BUN Test Cards

Use of the affected product can result in discrepant low pH and measured total carbon dioxide results.

Moderate risk, FDA, Device defect

Straumann N!Ce Full-Arch Restorations

Includes an incorrect screw seat interface.

Moderate risk, FDA, Device defect

Becton Dickinson BD GasPak EZ CO2 and Campy Pouch Systems

BD identified an issue affecting certain lots of BD GasPak EZ CO2 and BD GasPak EZ Campy Gas Generating Pouch Systems.

Moderate risk, FDA, Device defect

Merit Medical Systems Philips Bridge Prep Kit

The Philips Bridge Prep Kit may have a catheter that resists advancement over a guidewire.

Moderate risk, FDA, Device defect

Abbott Point of Care i-STAT EG7+, EG6+, and G3+ Cartridges

I-STAT cartridges may report higher PCO2 and lower pH results, appearing as severe respiratory acidosis.

Moderate risk, FDA, Manufacturing problem

Leksell Vantage Arc System

The Leksell Vantage Arc System may have locking mechanisms that do not secure properly, shifting coordinates during procedures.

Moderate risk, FDA, Device defect

Heraeus PALAMIX Duo and Uno

In units older than 1.5 years, the mixing rod may come loose from its lock during the mixing process.

Low risk, FDA, Device defect

Beta Bionics iLet Bionic Pancreas

The iLet Bionic Pancreas software may delay CGM readings, leading to severe hyperglycemia or hypoglycemia.

Moderate risk, FDA, Software defect

8 recalls that day

B. Braun Lactated Ringer's Injection

Lactated Ringer's Injection USP contains particulate matter that can cause patient harm if infused.

High risk, FDA, Foreign object

Optase Dry Eye Intense Drops (Glycerin 0.2%)

Optase Dry Eye Intense Drops lack assurance of sterility.

Moderate risk, FDA, Sterility problem

iVIZIA Sterile Lubricant Eye Drops

The eye drops lack assurance of sterility due to CGMP deviations found during an FDA inspection.

Moderate risk, FDA, Sterility problem

Negita Shrimp Crackers

Negita Cracker- Shrimp contains undeclared FD&C Yellow 6.

Moderate risk, FDA, Undeclared color or additive

American Regent Levocarnitine Injection

Levocarnitine Injection is missing its label.

Low risk, FDA, Labeling error

Specially Selected Vanilla Creme Brulee

Vanilla Creme Brulee may contain foreign objects, specifically glass.

Moderate risk, FDA, Ended, Foreign object

Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions

Wells Pharma Phenylephrine, Fentanyl and Ketamine Injectable Solutions have cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Siemens Healthcare Diagnostics Dimension Creatinine Flex Reagent Cartridge

This imprecision may lead to erroneously decreased or increased creatinine patient results.

Moderate risk, FDA, Device defect