🍎 Food Class I - Dangerous
Pasta label declares semolina flour but does not declare wheat.
All Recalls
95,089 total recalls in our database
🍎 Food Class I - Dangerous
Undeclared sesame
Sweet Alchemy Blackberry Crumble ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
Sweet Alchemy Ice Creamery
🍎 Food Class I - Dangerous
Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, and Wheat.
🍎 Food Class I - Dangerous
Product potentially contaminated with deer feces
🍎 Food Class I - Dangerous
Pasta label declares semolina flour but does not declare wheat.
Sweet Alchemy Toasted Black Sesame ice cream, distributed in pints. Label declares company name, flavor name, but does not declare ingredients and allergens.
Sweet Alchemy Ice Creamery
🍎 Food Class I - Dangerous
Ice cream grab n go Pint containers' labels do not declare any ingredients including allergens Egg, Milk, and Sesame.
Dofetilide Capsules 500 mcg (0.5mg), 60-count bottle, Rx Only, Manufactured by Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T of D & NH), India, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512. NDC 47335-063-86
SUN PHARMACEUTICAL INDUSTRIES
💊 Drugs Class I - Dangerous
Out of Specification result observed in content uniformity testing
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC 0264-5802-00
B. Braun Medical
💊 Drugs Class I - Dangerous
Labeling: Not Elsewhere Classified - the description, warnings, storage information and instructions for use are either missing or partially printed.
Randox RX Series Urea Enzymatic Kinetic Assay Ref. Numbers: (1) UR3825 (2) UR3873 (3) UR8334 (4) UR8070 (Modena)
Randox Laboratories
🏥 Medical Devices Class I - Dangerous
Carryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient samples, in urea assays results if the urea assay is run immediately after the Direct LDL-cholesterol assay. This may lead to a delay in reporting results or in falsely decreased urea test results.
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 17 - indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-117/00
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 25 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-25/00
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 14-Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur. Item Number: 136-114/00
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue
ARTIS pheno-Angiography systems developed for single and biplane diagnostic imaging and interventional procedures. Material Number: 10849000
Siemens Medical Solutions USA
🏥 Medical Devices Class I - Dangerous
Due to a hardware issue in the cable connectors of the system generator, a thermal overload in the cable connections may occur when performing excessive fluoroscopy/acquisitions, a burning smell may be detectable coming from the generator cabinet and the system may lose the imaging functionality of the corresponding plane and result in a situation where it is necessary to cancel clinical treatment or to continue treatment on an alternative system
VITROS Immunodiagnostic Products Troponin I ES Reagent Pack
ORTHO-CLINICAL DIAGNOSTICS
🏥 Medical Devices Class I - Dangerous
Reagent packs could potentially contain incorrect wells, which will generate incorrect, and potentially false negative, results.
Tracheal Intubation Fiberscope OLYMPUS LF-P- To be used with an Olympus Light Source, documentation equipment, display monitor and other ancillary equipment for management of Endotracheal Tube
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
CD HORIZON Spinal System Solera Awl Tip Tap, REF NAV2006K
Medtronic Sofamor Danek USA
🏥 Medical Devices Class I - Dangerous
Incorrect Laser Marking - Solera Awl Tip Tap
Total Hip Kit, REF DYNJ903275S; surgical convenience kit
MEDLINE INDUSTRIES, LP - Northfield
🏥 Medical Devices Class I - Dangerous
The prep solution included in the Total Hip Kit expires prior to the expiration date of the Kit.
Olympus Endoscope Reprocessor OER-Mini-For use in cleaning and high-level disinfection of heat sensitive Olympus flexible endoscopes and their accessories.
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
Revised OER-Pro, OER-Elite, OER-Mini endoscope reprocessor labeling- the LF-V and LF-P are no longer compatible endoscopes for reprocessing in the OERs. The addendum highlights the following changes: 1. Removal of LF-V and LF-P as compatible with the OER 2. Change conditions for ETO gas sterilization from 12% EtO to 100% EtO 3. Removing the reusable cleaning brush for the manual cleaning. Single Use brushes remain compatible
Ingenia Elition X Magnetic Resonance (MR) system, Product Numbers 781358, 782107, and 782118 (SmartPath to Ingenia Elition X)
Philips North America
🏥 Medical Devices Class I - Dangerous
During installation of the SmokeDetector Interlock, a connecting cable, between the SmokeDetector Interlock and the host PC, may not have been properly installed. This connection is used for service diagnostics and does not impact the functionality of the system and/or the SmokeDetector Interlock system.
LINK MP Monoblock Hip Stem, Trial Stem Instruments, Size 22 - Indicated for patients with Mobility-limiting diseases, fractures or defects of the hip joint or proximal femur Item Number: 136-22/00
Waldemar Link GmbH & Co. KG (Mfg Site)
🏥 Medical Devices Class I - Dangerous
Increased force may be required to remove the LINK MP Monoblock trial hip stem (Sizes 14mm - 25mm),after impaction. Potential for prolongation of surgery or the surgical procedure may have to be modified due to this issue