🍎 Food Class I - Dangerous
Undeclared allergens (Peanut) due to mispackaging
All Recalls
92,900 total recalls in our database
Turkeyfoot Creek Creamery Cookie Dough Artisan Ice Cream, One Pint (473 ml), packaged individually in a paper carton with paper lid
Turkeyfoot Creek Creamery
🍎 Food Class I - Dangerous
Undeclared allergens - soy and wheat
Sushi Wasabi; 5 grams (Ready to eat) Ingredients: Horseradish, Corn Oil, Salt, Water, Citric Acid, Tumeric, FD&C Blue#1 Distributed by: Tokyo Nori U.S.A, City of Industry, CA 91746
MING HONG INTERNATIONAL
🍎 Food Class I - Dangerous
Individual consumer size Wasabi mini pack label does not declare allergen ingredient Yellow 5.
🍎 Food Class I - Dangerous
Undeclared allergens (Peanut) due to mispackaging
💊 Drugs Class I - Dangerous
Sub-Potent Drug: Subpotent assay results during stability testing.
EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-880-02.
Mckesson Medical-Surgical Inc. Corporate Office
💊 Drugs Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
💊 Drugs Class I - Dangerous
Lack of Assurance of Sterility: A market complaint was received for leakage and empty ampoule.
💊 Drugs Class I - Dangerous
Sub-Potent Drug: Subpotent assay results during stability testing.
clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Lupin Pharmaceuticals
💊 Drugs Class I - Dangerous
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.
Mckesson Medical-Surgical Inc. Corporate Office
💊 Drugs Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21
Mckesson Medical-Surgical Inc. Corporate Office
💊 Drugs Class I - Dangerous
CGMP Deviations; potential temperature excursions due to transit delays
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT, REF DYNDH1462B; 2) BLOOD CULTURE KIT, REF DYNDH1622C; 3) BLOOD CULTR KT DIVRSN DEVICE, REF DYNDH1866.
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
🏥 Medical Devices Class I - Dangerous
In prior SmartSync application versions, the Abort button stopped the test that was selected. During an induction test, there was a limited window of time for the user to abort a therapy, thereby limiting the user's ability to cancel a high voltage therapy delivery.
Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human serum and plasma.
Beckman Coulter
🏥 Medical Devices Class I - Dangerous
A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different affinity of manufactured coated tubes to patient samples, causing falsely increased assay results for the impacted Estrone RIA kits.
Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB DRAW-SH, REF CDS860014P
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. This may constitute a breach to sterility, which may in turn lead to the infection related harms for the patient.
🏥 Medical Devices Class I - Dangerous
Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction.
Ellik Evacuator. Model Number: 194. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Tubing for Male Connector 194, Ellik Evacuator. Model Number: 190-4. The Ellik Evacuator and adapter accessories are compatible with Gyrus ACMI Elite and Elite 2 Resection Sheaths.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions For Use (IFU).
Biofinity XR Toric Contact Lens
CooperVision
🏥 Medical Devices Class I - Dangerous
Lens blisters may have an incomplete or leaking seal which may render them unsterile.
SIGNA Architect
GE Medical Systems
🏥 Medical Devices Class I - Dangerous
GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce elevated acoustic noise during scanning. As a result, acoustic levels can exceed 99dB, the limit established by International Electrotechnical Commission (IEC 60601-2-33) when using hearing protection with a Noise Reduction Rating (NRR) of 29dB, as currently required in the Operator Manual.