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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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12 recalls that day

Tops Strawberry and Mixed Fruit Jam

Tops Strawberry Jam and Tops Mixed Fruit Jam contain an unapproved color.

Moderate risk, FDA, Undeclared color or additive

Medicrea IB3D Universal Implant Inserter and PL Instruments Set

Medicrea IB3D Universal Implant Inserter and PL Instruments Set may have a handle that untreads, causing inability to rotate implant.

Moderate risk, FDA, Device defect

Medtronic Neuromodulation Vanta Clinician Programmer Application

The A71200 Vanta Clinician Programmer Application does not function as intended during use, potentially causing a prolonged or postponed surgical procedure.

Moderate risk, FDA, Device defect

Mobius Imaging AIRO Computed Tomography X-Ray System Pendants

AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.

Moderate risk, FDA, Labeling error

GE Medical Systems Israel Emission Computed Tomography Systems

Certain Nuclear Medicine systems could have been transported without adequate detector support, potentially causing a detector fall and life-threatening injury.

Moderate risk, FDA, Device defect

Boston Scientific Coyote Over-the-Wire PTA Balloon Dilation Catheters

The Coyote balloon catheter may not inflate or deflate properly during use.

Moderate risk, FDA, Device defect

House of Flavors Banana Pudding Ice Cream

Banana Pudding Ice Cream contains undeclared soy lecithin.

Moderate risk, FDA, Ended, Undeclared soy

Publix Rice & Pigeon Peas

Publix Rice & Pigeon Peas contain an undeclared allergen, soy.

Low risk, FDA, Ended, Undeclared soy

15 recalls that day

Gusto Group Shrimp Paste

Shrimp Paste (Klong Kone) tested high for lead, which can cause permanent damage to the central nervous system in children.

Moderate risk, FDA, Ended, Chemical contamination

BD Pyxis ES Enterprise Server

The BD Pyxis ES Enterprise Server has a software issue that may result in equipment not receiving timely updates.

Moderate risk, FDA, Software defect

Remote Diagnostic Technologies Philips Tempus Pro Patient Monitor and USB 2-Channel IBP Module

The Philips Tempus Pro Patient Monitor measures intracranial and bladder pressure, but these measurements have not been tested for accuracy.

Moderate risk, FDA, Device defect

Sophysa Pressio 2 ICP Monitoring System

The Pressio 2 ICP Monitoring System can reboot, causing customer complaints.

Moderate risk, FDA, Device defect

Abiomed Impella 5.5 with SmartAssist S2

The Impella 5.5 with SmartAssist S2 Set is packaged in an incorrect outer box carton.

Moderate risk, FDA, Device defect

Integra LifeSciences Codman Microsensor and CereLink ICP Sensor Basic Kits

The Codman Microsensor Basic Kit may have corrosion stains on its included needle.

Moderate risk, FDA, Device defect

Securitas Arial 900 MHz Call Stations

Arial 900 MHz Call Stations may fail to transmit a low battery alert before battery failure.

Moderate risk, FDA, Software defect

Medline Hudson RCI Medium Concentration Oxygen Masks

Oxygen masks have tubing that can disconnect, which may delay patient care and cause shortness of breath leading to hypoxia.

Moderate risk, FDA, Device defect

IMRIS HFD100 Head Fixation Device

The Head Fixation Device HFD100 has a torque screw that may crack or separate, risking patient injury.

Moderate risk, FDA, Device defect

South Asian Food Bengal King Jhal Chanachur Food Treats

Bengal King Jhal Chanachur food treats contain undeclared peanuts.

High risk, FDA, Ended, Undeclared peanut

Philips Smart-Hopping 2.0 AP 1.4 GHz Patient Monitor

The MX40 device could not reconnect when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.

Moderate risk, FDA, Device defect

Baraka French Style Puff Pastry and Gourmet Pastry Kunafe

Baraka French Style Puff Pastry and Gourmet Pastry Kunafe may contain partially hydrogenated oils.

Moderate risk, FDA, Ended, Undeclared color or additive

Meijer Steam Distilled Water

Meijer Steam Distilled Water contains a floating black foreign substance.

Moderate risk, FDA, Ended, Foreign object

Siemens LUMINOS Lotus Max and Luminos dRF Max

Luminos Lotus Max and Luminos dRF Max systems may have incorrect collimation when switching quickly between organ programs.

Moderate risk, FDA, Software defect

Philips Incisive CT

Philips Incisive CT may have an incomplete scan due to an unstable connection inside the floating sensor.

Moderate risk, FDA, Device defect

8 recalls that day

123Herbals Silintan 25 Pills

Silintan capsules contain undeclared meloxicam, which can cause serious life-threatening events.

High risk, FDA, Hidden drug ingredient

GBC Food Services EverRoast Chicken Caesar Salad and Wrap

GBC Food Services EverRoast Chicken Caesar Salad and Wrap may contain Listeria.

High risk, FDA, Ended, Listeria

McCain Foods Ore-Ida Tater Tots and Sysco Imperial Potato Tater Barrels

McCain Foods barrels contain clear hard plastic fragments.

Moderate risk, FDA, Ended, Foreign object

SpecGx Oxycodone and Acetaminophen CII Tablets

Oxycodone and Acetaminophen tablets may have a missing imprint.

Moderate risk, FDA, Quality testing problem

Waterfront Bistro and Market 32 Frozen Raw Shrimp

Shrimp may be contaminated with Cesium-137 (Cs-137).

Moderate risk, FDA, Ended, Chemical contamination

Vision RT AlignRT InBore System

The AlignRT InBore system has an omission in its Instructions for Use regarding laser information.

Moderate risk, FDA, Device defect

AvKARE Rosuvastatin Tablets

The product is out of specification for dissolution.

Moderate risk, FDA, Drug dissolving problem

CVA Medicated Cattle Feed Pellets and Meals

Other feed formulations also have incorrect thiamine and selenium levels.

High risk, FDA, Wrong nutrient levels

5 recalls that day

Carrot Top Kitchens Hummus

Carrot Top Kitchens hummus contains undeclared sesame, which can cause serious or life-threatening allergic reactions.

High risk, FDA, Ended, Undeclared sesame

Beckman Coulter UniCel DxI 600 and DxI 800 Immunoassay Systems

Beckman Coulter UniCel Dxl 600 and UniCel Dxl 800 analyzers may not restart after a standard shutdown, causing delayed results.

Moderate risk, FDA, Device defect

Sapori Amaretti Almonds Cookies

Sapori Amaretti Almonds Cookies contain elevated levels of hydrocyanic acid.

Moderate risk, FDA, Ended, Chemical contamination

Nutrena Country Feeds Cracked Corn

Nutrena Country Feeds Cracked Corn has elevated aflatoxin levels.

Moderate risk, FDA, Ended, Chemical contamination

Consumers Supply Distributing Country Vet and Heartland Harvest Dog Biscuits

Dog biscuits may be contaminated with Salmonella.

High risk, FDA, Ended, Salmonella

10 recalls that day

Prima Vera Nueva Tamales

Tamales may be contaminated with Listeria, which can cause serious infections.

Moderate risk, FDA, Ended, Listeria

Mayej Comercializadora Italian Parsley

Italian Parsley may contain Cyclospora cayetanensis.

Moderate risk, FDA, Contamination

Town Food Service Equip Aluminum Sauce Pans

Aluminum sauce pans contain leachable lead levels.

Moderate risk, FDA, Chemical contamination

Meridian Bioscience Revogene C. Difficile Assay

The Revogene C. difficile assay may give false-negative results due to declining performance over time.

Moderate risk, FDA, Device defect

MediNatura ReBoost and ClearLife Nasal Sprays

ReBoost and ClearLife nasal sprays contain yeast, mold, and microbial contamination.

High risk, FDA, Contamination

Sam Dry Fruits & Nuts Pistachio Meats Whole

Sam Dry Fruits & Nuts Pistachio Meats Whole may be contaminated with Salmonella.

High risk, FDA, Salmonella

Lunds & Byerlys Monster Cookies

Lund Food is recalling its Lunds & Byerlys Monster Cookies because it contains undeclared allergens (peanut, egg, soy).

High risk, FDA, Ended, Undeclared egg

ORL Kids Mouthwash and Natural Toothpaste

Signature Formulations is recalling its ORL Kids Mouthwash and ORL Kids Natural Toothpaste because of cGMP deviations.

Moderate risk, FDA, Manufacturing problem

Fresh & Ready Foods Breakfast Burritos and Tacos

Spicy Veggie Breakfast Burrito, Spicy Breakfast Burrito, Spicy Egg Potatoes Cheese Tacos, and Eggs Potatoes Cheese Tacos contain foreign material.

Moderate risk, FDA, Ended, Foreign object

Rovira Snack Crackers, Tempting Crackers, Vanilla Crackers

Rovira Snack Crackers, Tempting Crackers, Vanilla Crackers contain undeclared colors FD&C Yellow #6, and FD&C Red 40.

Moderate risk, FDA, Ended, Undeclared color or additive

6 recalls that day

Halyard Organ Recovery OR Pack and Mini Plus Kit South

Halyard Organ Recovery OR Pack and Halyard Mini Plus Kit South are not suitable for organ transplant.

High risk, FDA, Device defect

Roche Diagnostics Elecsys Anti-TSHR Immunoassay

The Elecsys Anti-TSHR immunoassay gives results that vary by platform and calibrator lot, which may lead to delayed or incorrect diagnosis and treatment.

Moderate risk, FDA, Device defect

Alembic Fesoterodine Fumarate Extended-Release Tablets

Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets may contain more impurities than allowed.

Low risk, FDA, Drug impurity

Imprimis NJOF Dexamethasone Moxifloxacin and Tri-Moxi+ Intraocular Injections

Imprimis NJOF injections contain particulate matter described as glass-like particles.

Moderate risk, FDA, Foreign object