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Found 12,723 results for "product recalls and alerts"
Food & Beverage
FDA Food
FDA Foodtippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783
IF Holding II, LLC
FDA FoodClass II
tippy toes apple pear banana 6 months & up baby food 2-4OZ (113g) PACKS NET WT 8 OZ (226g) DISTRIBUTED BY TOPCO ASSOCIATES LLC ELK GROVE VILLAGE, IL 60007 1-888-423-0139 PRODUCT OF USA UPC: 036800265783
Potential contamination with patulin.
Mar 11, 2026IF Holding II, LLC
PharmaceuticalFDA Drugs
FDA DrugsProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Rising Pharma Holding, Inc.
FDA DrugsClass II
Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendale, NJ 07401, Country of origin: Taiwan, NDC 16571-816-51.
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Mar 11, 2026Rising Pharma Holding, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: ShockPulse-SE Lithotripsy System Product Name: ShockPulse-SE Lithotripsy System - Generator Model/Catalog Number: SPL-G Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Mar 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesBrand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: ShockPulse-SE Lithotripsy System SPL-SR Product Name: ShockPulse-SE Lithotripsy System - Reusable Probes Model/Catalog Number: SPL-SR Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Mar 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesBrand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
B Braun Medical Inc
FDA DevicesClass II
Brand Name: B. Braun Product Name: 21GA WINGED INF SET Model/Catalog Number: 7M2802 Software Version: N/A Product Description: A device designed for subcutaneous implantation and intended to be used temporarily to expand an implanted tissue expander by percutaneous injection of air or fluids. Component: N/A
The potential for the needle tip to be dull/blunt, difficult to advance, and/or break.
Mar 11, 2026B Braun Medical Inc
Medical DeviceFDA Devices
FDA DevicesImpella RP. Product Code: 0046-0011.
Abiomed, Inc.
FDA DevicesClass I
Impella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Mar 11, 2026Abiomed, Inc.
Medical DeviceFDA Devices
FDA DevicesImpella RP with SmartAssist. Product Code: 0046-0035.
Abiomed, Inc.
FDA DevicesClass I
Impella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Mar 11, 2026Abiomed, Inc.
Food & BeverageFDA Food
FDA FoodLobster & Crab Ravioli. Keep Frozen. Contains: Wheat, Eggs, Milk, Crustaceans-Shellfish. Product is intended to be further cooked. Weight: 1-10 pound (4.5g). Use within 6 months. 801-541-9292-www.FunarosPerfectPasta.com. 1391 So. 300 West Slc, Ut 84115.
Perfect Pasta, Incorporated
FDA FoodClass I
Lobster & Crab Ravioli. Keep Frozen. Contains: Wheat, Eggs, Milk, Crustaceans-Shellfish. Product is intended to be further cooked. Weight: 1-10 pound (4.5g). Use within 6 months. 801-541-9292-www.FunarosPerfectPasta.com. 1391 So. 300 West Slc, Ut 84115.
Undeclared shrimp, crab, lobster, pollock (fish), whiting (fish), and soy.
Mar 11, 2026Perfect Pasta, Incorporated
Medical DeviceFDA Devices
FDA DevicesBrand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: Olympus ShockPulse-SE Lithotripsy System with Generator Product Name: ShockPulse-SE Lithotripsy System - Reuseable Probes Model/Catalog Number: SPL-SR, contains generator SPL-G Product Description: An assembly of devices that uses a combination of, or individually applied, pneumatically-created ballistic shock waves and ultrasonic waves for the intracorporeal fragmentation of stones (calculi) in the urinary tract (i.e., kidney, ureter, and bladder) for their removal. It typically includes a pressure and power regulator/control unit, handpieces, and two types of probes of various sizes. The probes are attached to the two handpieces which are connected to the control unit that supplies the energy for both the pneumatic and ultrasonic functions. Energy is applied to a calculus which is fragmented in situ and removed via a suction system facilitated by the lithotripsy system.
Mis-wired component-the improperly wired component can result in additional noise on the power supply output. Noise on the ultrasonic input circuit is not consistent with electromagnetic compatibility (EMC) standards and may decrease the overall reliability of the system and result in delay of treatment. It was discovered that additional serial numbers of ShockPulse generators may also have the mis-wired component. As a result, this is expanding the action to the additional impacted devices.
Mar 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesBrand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
Diagnostica Stago, Inc.
FDA DevicesClass II
Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable
The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values.
Mar 11, 2026Diagnostica Stago, Inc.
Medical DeviceFDA Devices
FDA DevicesBrand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Olympus Corporation of the Americas
FDA DevicesClass II
Brand Name: ShockPulse-SE Lithotripsy System SPL-S Product Name: ShockPulse-SE Lithotripsy System - Single Use Probes Model/Catalog Number: SPL-S Product Description: The ShockPulse Lithotripsy System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The ShockPulse transducer is a reusable device that requires cleaning and steam sterilization prior to use in order to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy that quickly disintegrates stones.
Ongoing investigations identified additional instances of the device Generator remaining in a blinking phase waiting to recognize the transducer. Damage to the transducer plug and/or generator receptacle may cause these issues.
Mar 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodJunebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN CHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), DRIED CHERRIES, ALMONDS; OAT FLOUR, COCOA POWDER, ORANGE ZEST, VANILLA EXTRACT (VANILLA BEAN EXTRACTIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUPMENT ALSO HANDLING PEANUT, SESAME. PRODUCED IN A FACILITY THAT ALSO PROCESES GLUTEN PRODUCTS. KEEP REFRIGERATED; UPC: 8 60012 38462 4
Juniper Granola, LLC
FDA FoodClass I
Junebar Chocolate Cherry All Natural Snack Bar; INGREDIENTS: ORGANIC ALMOND BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN CHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), DRIED CHERRIES, ALMONDS; OAT FLOUR, COCOA POWDER, ORANGE ZEST, VANILLA EXTRACT (VANILLA BEAN EXTRACTIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUPMENT ALSO HANDLING PEANUT, SESAME. PRODUCED IN A FACILITY THAT ALSO PROCESES GLUTEN PRODUCTS. KEEP REFRIGERATED; UPC: 8 60012 38462 4
Products contain undeclared milk and soy.
Mar 11, 2026Juniper Granola, LLC
Medical DeviceFDA Devices
FDA Devicescobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL
Roche Diagnostics Operations, Inc.
FDA DevicesClass II
cobas pro integrated solutions with cobas c 503 analytical units: cobas pro sample supply unit, material number 08464502001 cobas pro SSU, material number 09205632001 Affected Assays: (Product Name/ Catalog Number/ Application Code/ Application Short Name) 1. Cystatin C Gen.2 08105596190 20510 CYSC2 2. Ferritin Gen.4 08057648190 20571 FER4X 3. Lipoprotein (a) Gen.2 08106126190 20861 LPA2X 4. Lipoprotein (a) molarity 08106126160 20864 LPA2-X 5. Vancomycin Gen.3 08058849190 21211 VANC3O 6. Kappa Free Light Chains Partner Channel 08896640190 21421 KFLCX 7. Lambda Free Light Chains Partner Channel 08896631190 21430 LFLC 8. fCAL turbo Partner Channel 08910367190 21490 FCAL
Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitative, semi-quantitative and quantitative clinical chemistry and immunochemistry assays, as well as ion-selective measurements. When an erroneous calibration is active, the instrument fails to calculate new values and instead repeats the last successfully calculated result from any Spline-type assay for all subsequent measurements, leading to identical and erroneous patient and QC results. The defect could lead to patients receiving erroneous lab results, which could result in a remote risk of serious adverse health consequences. The following assays use spline type calibration and are affected by this issue: Cystatin C Gen.2, Ferritin Gen.4, Lipoprotein (a) Gen. 2, Lipoprotein (a) molarity, Vancomycin Gen.3, Kappa Free Light Chains Partner Channel, Lambda Free Light Chains Partner Channel, and fCAL turbo Partner Channel.
Mar 11, 2026Roche Diagnostics Operations, Inc.
Safety Alert
Health Canada
Health CanadaVENLAFAXINE XR: out of specification
Drugs and health products
Health CanadaType II
VENLAFAXINE XR: out of specification
Product quality
Mar 10, 2026Drugs and health products
Safety AlertHealth Canada
Health CanadaIXCHIQ (chikungunya vaccine, live, attenuated) and the Risk of Serious Adverse Reactions in Medically Frail Individuals 65 Years of Age and Older
Marketed health products
Health CanadaGeneral Alert
IXCHIQ (chikungunya vaccine, live, attenuated) and the Risk of Serious Adverse Reactions in Medically Frail Individuals 65 Years of Age and Older
New safety information - Product safety - Adverse reaction
Mar 9, 2026Marketed health products
Safety AlertHealth Canada
Health CanadaKETOROLAC: The weight is out of specification in the affected lots.
Drugs and health products
Health CanadaType II
KETOROLAC: The weight is out of specification in the affected lots.
Product quality
Mar 9, 2026Drugs and health products
Safety AlertHealth Canada
Health CanadaMagnetic Chess Game recalled due to ingestion hazard
Consumer product safety
Health CanadaGeneral Alert
Magnetic Chess Game recalled due to ingestion hazard
Ingestion hazard
Mar 6, 2026Consumer product safety
Safety AlertHealth Canada
Health CanadaFidget Magnetic Pen recalled due to ingestion hazard
Consumer product safety
Health CanadaGeneral Alert
Fidget Magnetic Pen recalled due to ingestion hazard
Ingestion hazard
Mar 6, 2026Consumer product safety
Safety AlertHealth Canada
Health CanadaVarious macadamia nuts and macadamia nut-containing products recalled due to Salmonella
CFIA
Health CanadaClass 2
Various macadamia nuts and macadamia nut-containing products recalled due to Salmonella
Salmonella
Mar 5, 2026CFIA
Safety AlertHealth Canada
Health CanadaAPO-BRIMONIDINE-TIMOP: The weight is out of specification in the affected lot.
Drugs and health products
Health CanadaType II
APO-BRIMONIDINE-TIMOP: The weight is out of specification in the affected lot.
Product safety
Mar 5, 2026Drugs and health products
Food & BeverageFDA Food
FDA FoodMung Beans packaged in 4lb polybags; 6-4lb bags per carton
LUBNA QUALITY PRODUCTS INC.
FDA FoodClass III
Mung Beans packaged in 4lb polybags; 6-4lb bags per carton
Presence of Thiamethoxam-PESTICIDE
Mar 4, 2026LUBNA QUALITY PRODUCTS INC.
Medical DeviceFDA Devices
FDA DevicesBrand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Encore Medical, LP
FDA DevicesClass II
Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 7L 16MM, VE Model/Catalog Number: 341-16-707
Knee and Humeral socket implants contain incorrect labeling.
Mar 4, 2026Encore Medical, LP
Medical DeviceFDA Devices
FDA DevicesBrand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Encore Medical, LP
FDA DevicesClass II
Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number: 509-00-432
Knee and Humeral socket implants contain incorrect labeling.
Mar 4, 2026Encore Medical, LP
Food & BeverageFDA Food
FDA FoodGerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Gerber Products Company dba Nestle Infant Nutrition
FDA FoodClass II
Gerber Arrowroot Biscuits, Net Wt. 5.5 oz. (155g), packaged in a plastic resealable bag with UPC 015000005962, packed 4 bags/case with UPC 015000935726; Made for Gerber Products Co., Fremont, MI 49413
Downstream recall. Product contains arrowroot flour ingredient that was voluntarily recalled by the supplier due to potential contamination of soft kraft paper/plastic bag pieces.
Mar 4, 2026Gerber Products Company dba Nestle Infant Nutrition