All recalls
- 2026-03-11FDA-DeviceStaar Surgical AGClass IIEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
Toric Implantable Collamer for correction/reduction of myopia in phakic eyes with astigmatism were labeled as 12.1 mm length but are 12.6 mm length lenses, so there is the potential for excessive vault, which may cause: Significant reduction of irido-corneal angles, Significant shallowing of anterior chamber, Patient discomfort, Elevated IOP/Angle closure, Unreactive pupil, Lens exchange/removal.
- 2026-03-11FDA-DeviceOlympus Corporation of the AmericasClass IIBrand 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 dis
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.
- 2026-03-11FDA-DeviceOlympus Corporation of the AmericasClass IIBrand 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 th
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.
- 2026-03-11FDA-DeviceOlympus Corporation of the AmericasClass IIBrand 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 th
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.
- 2026-03-11FDA-DeviceRoche Diagnostics Operations, Inc.Class IIcobas 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
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.
- 2026-03-11FDA-DeviceGE HealthcareClass IIGE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological
Under certain workflows, patient information shown in the viewer may not match the images displayed on Centricity Universal Viewer Zero Footprint Client (ZFP) with versions ZFP v6.0: SP11.6, SP11.6.0.1 and SP11.6.1 on systems with Patient Timeline installed,
- 2026-03-11FDA-DeviceAbiomed, Inc.Class IImpella RP. Product Code: 0046-0011.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceAbiomed, Inc.Class IImpella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-DeviceAbiomed, Inc.Class IImpella RP with SmartAssist. Product Code: 0046-0035.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
- 2026-03-11FDA-FoodPerfect Pasta, IncorporatedClass ILobster & 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.
- 2026-03-11FDA-FoodKarns Prime And Fancy FoodsClass IKarns Foods, Mini Dark Chocolate Raspberry Cups, 8 oz Clear plastic tamper evident packs, 36-42 packed per breakout
Product may contain undeclared peanuts.
- 2026-03-11FDA-FoodIF Holding II, LLCClass IItippy 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.
- 2026-03-11FDA-FoodJuniper Granola, LLCClass IJunebar 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
Products contain undeclared milk and soy.
- 2026-03-11FDA-FoodJuniper Granola, LLCClass IJunebar Peanut Chocolate Chip All Natural Snack Bar; INGREDIENTS: ORGANIC PEANUT BUTTER, DATE PASTE, ORGANIC BLACK BEANS, ORGANIC SWEET POTATOES, GLUTEN FREE ROLLED OATS, SEMI-SWEET SOY FREE VEGAN SHOCOLATE CHIPS (ORGANIC CANE SUGAR, UNSWEETENED CHOCOLATE, COCOA BUTTER), PEANUTS, OAT FLOUR, VANILLA EXTRACT (VANILLA BEAN EXTRATIVES IN WATER, ALCOHOL), FLAX, CINNAMON, SEA SALT, BAKING POWDER; ALLERGEN WARNING: CONTAINS PEANUTS, TREE NUTS (ALMOND, COCONUT), PRODUCED ON EQUIPMENT ALSO HANDLING PEANU
Products contain undeclared milk and soy.
- 2026-03-11FDA-FoodItalianway Import, Inc.Class IIVERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free, 600g NET WT. 1 LBS. 5.2 OZ., packaged in paper cartons, 6 units per case. Lot 217666, UPC 8002114019833
Potential contamination with foreign material (Teflon fragments) from flaking cooking molds.
- 2026-03-11FDA-FoodBader Enterprises, Inc.Class IIPremium Food Bubble Gum, packed in 2.5 oz clear flexible plastic packaging, all lots and codes. Sold in unit case of 30 LB.
Contains undeclared colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
- 2026-03-11FDA-FoodBader Enterprises, Inc.Class IIPremium Food Jordan Almonds, packed in 2.0 oz and 3.5 oz clear flexible plastic packaging.
Contains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake).
- 2026-03-11FDA-DrugMYLAN PHARMACEUTICALS INCClass IIAmnesteem (Isotretinoin) Capsules, USP 40 mg, packaged in 3 x 10-Count Prescription Packs, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA, Made in France, NDC 0378-6614-93.
Failed Dissolution Specifications
- 2026-03-11FDA-DrugStuffbyNainaxClass IMR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared sildenafil and tadalafil
- 2026-03-11FDA-DrugMohamed HagarClass IMojo Max Fusion XXX, 500 mg, one capsule per blister card, 20 count box, Distributed by: Max Nutrition Inc. UPC 6 78945 36675 0
Marketed Without an Approved NDA/ANDA-FDA analysis revealed undeclared sildenafil (13.1 mg/capsule) and tadalafil (13.8 mg/capsule).
- 2026-03-11FDA-DrugNew Life Pharma LLCClass IITirzepatide Inj, 15mg x 4, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-04.
Lack of Assurance of Sterility
- 2026-03-11FDA-DrugNew Life Pharma LLCClass IITirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
Lack of Assurance of Sterility
- 2026-03-11FDA-DrugNew Life Pharma LLCClass IISemaglutide Inj., 2 mg x 5, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-06
Lack of Assurance of Sterility
- 2026-03-11FDA-DrugNew Life Pharma LLCClass IISemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
Lack of Assurance of Sterility
- 2026-03-11FDA-DrugRadnostixClass IISodium Iodide (I-131) Solution, Therapeutic Oral, packaged as a) 1 ml V-vial, NDC 69208-003-15; Order 49317, 49323, 49325, 49329, 49333, 49339, 49341,49355, 49364, 49380, 49392. (b) 2 ml V-Vial, NDC 69208-003-25; Order 49353,49457, 49477. (c) 3 ml V-vial, NDC 69208-003-35; Order 49454,49406. Rx Only, Manufactured by: International Isotopes Inc., Idaho Falls, ID.
Presence of Particulate Matter: Due to production issues
- 2026-03-11FDA-DrugANTHONY TRINH, 123Herbals LLCClass ISILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
Marketed Without an Approved NDA/ANDA: FDA analysis revealed the presence of undeclared meloxicam.
- 2026-03-11FDA-DrugHTO Nevada Inc. dba KirkmanClass IIMAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.
Stability Data Does Not Support Expiry Date.
- 2026-03-11FDA-DrugHTO Nevada Inc. dba KirkmanClass IIMAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.
Stability Data Does Not Support Expiry Date.
- 2026-03-11FDA-DrugHTO Nevada Inc. dba KirkmanClass IIFIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Stability Data Does Not Support Expiry Date.
- 2026-03-11FDA-DrugRising Pharma Holding, Inc.Class IIProduct 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