HALYARD Laparoscopy Comprehensive Pack II
Laparoscopy packs labeled as latex free contain a latex urethral catheter.
Labeling error recalls
Recalls flagged for labeling error, newest first. 128 recalls
2 recalls
Medical Action Industries Kit: Urinary Clean Catch 20/cs
An internal data-entry error caused kit lot 333606 to be labeled with an expiration date of March 31, 2027, instead of February 28, 2027.
2 recalls
Expressaire and ASP Global Disposable Tourniquet Cuffs
Disposable Tourniquet Cuffs have an incorrect expiration date, as they are labeled with a 10-year shelf life instead of the validated 5 years.
64 products
Karl Storz HOPKINS Telescopes
Hopkins telescopes have an incorrect inside packaging label for the eyepiece.
4 recalls
American Red Cross Apheresis Red Blood Cells, Leukocytes Reduced
Apheresis Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested antigen positive.
American Red Cross Leukocytes Reduced Red Blood Cells
Red Blood Cells, Leukocytes Reduced were labeled as antigen negative but were collected from a donor who tested positive.
Pipeline Flex Embolization Device with Shield Technology
The Pipeline Flex Embolization Device with Shield Technology has incorrect label dimensions, being 2.50 mm instead of 3.00 mm.
Percussionaire Intrapulmonary Percussive Ventilation and Phasitron Breathing Circuits
Reason given by FDA: Labeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV may alter controlled delivery of volatile anesthetic agents, resulting in deeper/lighter anesthetic effects that may result in hypertonia/hypotonia, tachycardia/ bradycardia, elevated intracranial pressure.
7 products
2 recalls
Almond Joy and Reese's Crunchy Peanut Ice Cream Bar
Reese's Crunchy Peanut Ice Cream Bar has inaccurate Nutrition Facts information listed on product.
2 products
Baxter Pro+ MRS Surfaces for VersaCare
PRO+ MRS Surface for Versacare has an error in its UDI label that may lead to incorrect product identification.
3 products
1 recall
ForeSight Elite Tissue Oximetry Cable
The ForeSight Elite Tissue Oximetry Cable has incorrect switching of channels 1 and 2 on the module and flag labels.
2 recalls
Olympus EZDilate Endoscopic Balloon Dilators
Reason given by FDA: Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm.
1 recall
ICU Medical 0.9% Sodium Chloride Injection
0.9% Sodium Chloride Injection may be mixed up with Potassium Chloride Injection, which can cause adverse events and potentially fatal outcomes.
1 recall
Elegant Foods Carrot Cake, Coconut Flakes, and Golden Raisins
Coconut flakes and golden raisins contain undeclared sulfites, and carrot cake has undeclared Yellow #5 and #6.
3 products
1 recall
OurPharma FentaNYL Citrate Injection Solution
FentaNYL Citrate Injection solution has a labeling discrepancy between the IV bag expiry and the product expiry.
1 recall
Freshpoint Central Florida Cranberry Chicken Salad Wedge
Cranberry Chicken Salad Wedge has an improperly declared allergen, egg, which is not listed in the Contains statement.
1 recall
B Braun Medical Discofix Four Way Stopcock Extension Sets
The Discofix Four WAY Stopcock has an incorrect expiration date printed on the carton shipper label.
1 recall
American Health Packaging Buprenorphine Sublingual Tablets
Buprenorphine Sublingual Tablets have a labeling mix-up.
1 recall
The One SPF 50 Invisible Sunscreen Gel
THE ONE SPF 50 INVISIBLE SUNSCREEN GEL may not reliably provide the SPF 50 protection stated on the label.
4 products
3 recalls
Africando Foods Alfredo Hot Sauce
Reason given by FDA: Labeling, wheat not listed as sub ingredient of chicken bouillon (minor ingredient), and soybean oil missing from ingredient list.
3 products
Byron White Herbal Supplements
Byron White FORMULAS A-L Complex Herbal Supplement may contain walnuts, which are not listed on the label.
3 products
Olympus POWERSEAL Curved Jaw Sealer & Divider
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
2 recalls
Halyard Total Joint and DaVinci TruCustom Bundles
Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
8 products
Medline Trach Tube Kit
The Medline medical convenience kit labeled as Trach Tube Kit has a component labeling discrepancy.
1 recall
Straumann Bone Level Tapered (BLT) Implant
The Straumann Bone Level Tapered Implant may contain implants that are 12mm instead of 14mm.
1 recall
Straumann GM Helix Dental Implants
There may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label.
3 recalls
Sheandro Vodka Tomato Sauce
Reason given by FDA: Label declares cream and cheese, but Milk is not declared.
Medline Micro-Kill Bleach Germicidal Bleach Wipes
Medline Micro-Kill Bleach Germicidal Bleach Wipes may have reduced bleach concentration before the end of their shelf life.
4 products
GORE VIABIL Short Wire Biliary Endoprosthesis
The GORE VIABIL biliary endoprosthesis may be mislabeled, with a 10 mm x 7 cm device labeled as a 10 mm x 10 cm device.
2 products
2 recalls
TISSIUM COAPTIUM Connect Peripheral Nerve Repair Devices
Currently labeled shelf life of 36 months is not substantiated by real-time data.
8 products
Freudenberg Medical Blom-Singer Classic Indwelling Voice Prosthesis
The Blom-Singer Classic Indwelling Voice Prosthesis has incorrect labeling.
2 products
2 recalls
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base
Sura Tanmen Hot and Sour Flavor ramen noodle kit may contain undeclared fish allergen, posing a risk of serious allergic reaction.
JINA F&C Wangshin Doenjang Soybean Paste
Reason given by FDA: Product label allergen "contains" statement does not include anchovy(fish).
1 recall
Fresenius Kabi Morphine Sulfate Injection
Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
1 recall
Terex Utilities Power Over Fiber Base Module
The Power Over Fiber Base Module is not certified and is improperly labeled.
1 recall
Mellish Island Super Skin Dietary Supplement
Firm's finished product label does not declare the source of marine collagen which was determined to be fish.
2 recalls
Eridanous Greek Style Shortbread Cookies
Shortbread cookies with undeclared wheat, soy, milk, eggs, and tree nut (coconut) can cause serious or life-threatening allergic reactions.
2 products
Man Fon Wonton Wrappers
Man Fon Wonton Wrappers contain undeclared colors Yellow#5 and Yellow#6.
2 products
1 recall
Pipeline Flex Embolization Device with Shield Technology
Incorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants contain 20 mm implants.
4 products
1 recall
MG Foods Spicy Breakfast Burritos
Spicy Breakfast Burritos may contain undeclared soy, posing a risk of serious allergic reaction.
1 recall
Enovachem Pharmaceuticals Lidolog Kit
The Lidolog Kit has a label that covers the barcode, making it hard to scan.
1 recall
Boston Scientific FARASTAR Ablation Generators and Cardiac Ablation Catheters
Farastar ablation generators and catheters have labeling that does not include Farapoint PFA catheter information.
3 products
1 recall
Orthofix Minirail External Fixation Devices
Unilateral external fixation devices may be incorrectly labeled.
4 products
1 recall
Vitalant Apheresis Platelets, Leukocytes Reduced, Irradiated
Apheresis Platelets, Leukocytes Reduced, Irradiated were labeled as leukocytes reduced but were not tested to verify white blood cell count.
3 recalls
Lannett Dextroamphetamine and Amphetamine Extended-Release Capsules
These capsules are labeled as extended-release but contain only immediate-release pellets.
BD Medline 111 Gravity Set
The gravity set was shipped as an engineering sample labeled not for human use.
Covidien Shiley Disposable Decannulation Plug
The Covidien Shiley Disposable Decannulation Plug has incorrect labeling that includes a symbol for non-DEHP, but the product contains DEHP.
1 recall
Eunha Fisheries Sliced Korean Halibut and Flounder Sashimi
Sliced Korean Halibut and Flounder Sashimi contain undeclared wheat, soy, and sesame, which can cause serious allergic reactions.
2 products
5 recalls
Central Admixture Pharmacy Services Pediatric Total Parenteral Nutrition Bags
The Total Parental Nutrition bag lacks copper and famotidine as labeled.
