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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

CooperVision Softmed Breathables Advanced Toric Contact Lenses

The contact lens carton incorrectly states it is indicated for extended wear, but it is not approved for that use.

Moderate risk, FDA, Unapproved product

Boston Scientific Cork Direxion Torqueable Microcatheters

The Direxion Torqueable Microcatheter is defective due to insufficient UV curing of the hydrophilic coating and raised ridges on nitinol sleeves.

Moderate risk, FDA, Device defect

Life Technologies Ion Torrent Genexus Dx Integrated Sequencer

The Ion Torrent Genexus Dx with software has vulnerabilities in its DNA or RNA sequencing system software.

Moderate risk, FDA, Software defect

Techno-Path Multichem AE Unassayed Chemistry Controls

Techno-Path Multichem AE quality control material has a stability drift affecting the Ammonia analyte, which may delay results to physicians.

Moderate risk, FDA, Labeling error

Biomedical Data Solutions Ortho Connect Software

Ortho Connect software can incorrectly reject potential discrepant results during result review.

Moderate risk, FDA, Ended, Software defect

ARUP Laboratories Apheresis Platelets, PAS, Leukocytes Reduced

The platelets were labeled as leukocytes reduced but were not tested to verify residual white blood cell count, and pH testing was not performed.

Moderate risk, FDA, Ended, Hospital use, Quality testing problem

8 recalls that day

Wedgewood Village Pharmacy Compounded Veterinary Medications

Wedgewood compounded veterinary medications may be weaker than labeled.

Not yet rated, FDA, Wrong drug strength

Trader Joe's Crispy Rice Milk Chocolate Bars

Trader Joe's Crispy Rice Milk Chocolate Bar has undeclared wheat due to an incorrect outer label.

Moderate risk, FDA, Undeclared wheat

Wild West Seed Broccoli Seeds Green Sprouting Calabrese and Waltham29

Wild West Seed is recalling its Wild West Seeds Broccoli Seeds Green Sprouting Calabrese and Wild West Seeds Broccoli Waltham29 Seeds because of Salmonella.

High risk, FDA, Salmonella

Walker Foods Marca El Pato Salsa Para Enchiladas

Marca El Pato Salsa para Enchiladas contains undeclared salt, garlic, and onions.

Moderate risk, FDA, Labeling error

Evexias Health Solutions Amino Ultra Dietary Supplement

Amino Ultra dietary supplement is mislabeled and fails to declare fish oil.

Moderate risk, FDA, Labeling error

Beckman Coulter Rotor SW40 and SW41

Beckman Coulter Rotor SW40 and SW41 may break into two or more pieces.

Moderate risk, FDA, Device defect

Medtronic MiniMed CareLink Clinic

CareLink Clinic software has a defect that can lead to incorrect insulin dosing.

Moderate risk, FDA, Software defect

VACUETTE Blood Collection Tubes with Lithium Heparin and Gel Separator

The Vacuette blood collection tube may contain EDTA contamination, leading to falsely elevated potassium and falsely decreased calcium results.

Moderate risk, FDA, Contamination

5 recalls that day

Great Value Fruit Cocktail in Fruit Juice

Great Value Fruit Cocktail in Fruit Juice from Concentrate may contain elevated levels of lead.

Moderate risk, FDA, Chemical contamination

Right Value Drug Stores Testosterone Cypionate

Testosterone Cypionate, 200 mg/mL, lacks sterility assurance.

Moderate risk, FDA, Sterility problem

Voila! Juice and Andronico's Community Markets Orange Juice

Voila! Juice and Andronico's Community Markets Orange Juice were not processed to achieve 5-log pathogen reduction.

Moderate risk, FDA, Contamination

Ventec Life Systems VOCSN, V+Pro, VC and V*Home Ventilators

The ventilator's internal flow transducer cable connector may disconnect from the internal board.

High risk, FDA, Device defect

El Ruisenor De Mexico: 61 products

Nuts, seeds, dried fruit, flours, snacks, gummies and more each have an undeclared allergen ingredient, such as wheat, sesame, peanuts, milk or sulfites.

High risk, FDA, Undeclared sesame

4 recalls that day

Caledonia Farmers Elevator CFE Broiler Starter & Grower Chicken Feed

CFE Broiler Starter & Grower feed contains elevated salt.

Not yet rated, FDA, Wrong nutrient levels

American Regent BetaVet Betamethasone Injectable Suspension for Horses

BetaVet injectable suspension for horses has defective container seals.

Moderate risk, FDA, Packaging defect

Sempio Yellow Peach

Sempio Yellow Peach contains elevated levels of lead.

Moderate risk, FDA, Chemical contamination

Pritam International Toothpastes

Pritam International Toothpastes have CGMP deviations.

Moderate risk, FDA, Manufacturing problem

14 recalls that day

Gelatelli Coffee & Vanilla Gelato

Gelatelli Coffee & Vanilla Gelato with Coffee Sauce & Cookie Pieces may be contaminated with Listeria, which can cause serious infections.

High risk, FDA, Listeria

Ascend Laboratories Amlodipine and Olmesartan Medoxomil Tablets

Out of specification due to dissolution.

Moderate risk, FDA, Drug dissolving problem

Shenzhen Techdow Pharmaceutical Heparin Sodium Injection

Heparin Sodium Injection lacks assurance of sterility.

Moderate risk, FDA, Sterility problem

Mylan Telmisartan and Amlodipine Tablets

Mylan Telmisartan and Amlodipine Tablets may be stronger than labeled.

Low risk, FDA, Wrong drug strength

Hikma Abirtega (Abiraterone Acetate) Tablets

The tablets failed weight uniformity specifications.

Moderate risk, FDA, Quality testing problem

Pfizer Levoxyl Levothyroxine Sodium Tablets

Pfizer Levoxyl Tablets may be weaker than labeled.

Moderate risk, FDA, Wrong drug strength

Gearharts Fine Chocolates Chocolate Confections

Broken glass was found in a piece of finished product.

Moderate risk, FDA, Foreign object

Philips Smart-Hopping 2.0 AP 1.4 GHz

Philips Smart-hopping 2.0 AP 1.4 GHz has unreliable wireless roaming behavior that can cause loss of connectivity to the central monitoring system.

Moderate risk, FDA, Device defect

Medtronic NDI Passive Spheres and Biopsy Needle Kit

Medtronic NDI Passive Spheres and Biopsy Needle Kit have variation in reflective material that may affect navigation tracking.

Moderate risk, FDA, Device defect

B Braun SAFSITE Injection Site

The product has a potential for leakage and backflow at the Safsite valve.

Moderate risk, FDA, Device defect

Philips Lumify Diagnostic Ultrasound System

The Philips Lumify Diagnostic Ultrasound System may not recognize transducer registration, prevent scanning, or have unstable connections.

High risk, FDA, Device defect

Think Surgical Square Driver

The square driver failed to meet design specifications.

Moderate risk, FDA, Quality testing problem

Abbott Amplatzer Amulet Left Atrial Appendage Occluder

The Amplatzer Amulet Left Atrial Appendage Occluder has changes to its instructions regarding risk of pulmonary artery injury.

Moderate risk, FDA, Device defect

Axonics PNE Lead Implant Kit

The PNE Lead Implant Kit may leak, break, or experience other issues that may pose a risk to users.

Moderate risk, FDA, Device defect

15 recalls that day

Pur Aqua Sparkling Frost Cherry Limeade

Pur Aqua Sparkling Frost Cherry Limeade may contain undeclared aspartame.

Low risk, FDA, Undeclared color or additive

Daring Foods Plant Steak Bites

Plant Steak Bites in a microwaveable pouch have defective packaging that can rupture during cooking.

Moderate risk, FDA, Packaging defect

Medline Foot Ankle Convenience Kit

The Medline convenience kit labeled Foot Ankle has a discrepancy in the shelf-life of a component.

Moderate risk, FDA, Device defect

Healthmark Vinyl Instrument Guards

Vinyl Instrument Guards have labeling that is not compliant with regulations and their steam sterilization instructions have been updated.

Moderate risk, FDA, Labeling error

Merit Medical Systems Scout MD Delivery System

The Scout MD Delivery System may have difficulty deploying, which could prevent the reflector from functioning.

Moderate risk, FDA, Device defect

Intelerad IntelePACS and InteleConnect Portal Radiological Image Processing Systems

IntelePACS and InteleConnect Portal/Tech Portal may show report and displayed images that do not match.

Moderate risk, FDA, Device defect

Medline Convenience Kits Containing CONMED AirSeal Access Ports

Convenience Kits containing Conmed AirSeal Access Ports may cause delays or ending procedures due to erroneous overpressure alerts and system venting.

Moderate risk, FDA, Device defect

Medline Surgical Convenience Kits

Medline surgical convenience kits contain cannula components that may leak or break during use.

Moderate risk, FDA, Device defect

Howmedica Osteonics Triathlon Hinge Femoral Prep, Femoral Prep, Misc. Instruments and Universal Baseplate Finishing Trays

The reprocessing instructions specify a 30-minute dry time for trays sterilized in blue wrap.

Moderate risk, FDA, Device defect

Cook Williams Cystoscopic Injection Needles

Williams Cystoscopic Injection Needles may have a misaligned Luer lock adapter, potentially causing increased procedural time and inadequate treatment.

Moderate risk, FDA, Device defect

Beckman Coulter DxU 840m Iris, DxU 850m Iris, IQ200 Sprint Analyzers

DxU 840m Iris, DxU 850m Iris and IQ200 Sprint may leak lamina fluid onto the table or floor if a check valve is not replaced annually.

Moderate risk, FDA, Device defect

Magellan Diagnostics LeadCare II Blood Lead Test Kit

The LeadCare II Blood Lead Test Kit may show a wrong expiration date, causing an error and delayed results.

Low risk, FDA, Labeling error

Radiometer Medical ABL90 FLEX and ABL90 FLEX PLUS Analyzers

The ABL90 Flex and ABL90 Flex Plus analyzers may give inaccurate results, requiring changes to instructions for use.

Moderate risk, FDA, Device defect