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Medical Device
FDA 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
PharmaceuticalFDA Drugs
FDA DrugsMetoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Teva Pharmaceuticals USA, Inc
FDA DrugsClass II
Metoprolol Succinate Extended-Release Tablets, 25 mg, 100 tablets bottles (NDC: 45963-709-11) and 1,000 tablets bottles (NDC: 45963-709-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054
Failed Dissolution Specifications
Mar 11, 2026Teva Pharmaceuticals USA, Inc
Vehicle RecallNHTSA
NHTSAVolvo Car USA, LLC - Seat Belt Warning System Malfunction/FMVSS 208
Volvo Car USA, LLC
NHTSASEAT BELTS
Volvo Car USA, LLC - Seat Belt Warning System Malfunction/FMVSS 208
An audible warning chime that does not properly alert of an unbelted seat belt can increase the risk of injury during a crash.
Mar 11, 2026Volvo Car USA, LLC
PharmaceuticalFDA Drugs
FDA DrugsCleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
ACME UNITED CORPORATION
FDA DrugsClass II
Cleansing Towelette (Benzalkonium Chloride 0.13%), 5"x 7", 1,000 case/Bulk, Med-Nap, Brooksville, FL 34601, Made in USA, NDC 0924-0243-00.
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
ACME UNITED CORPORATION
FDA DrugsClass II
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-01
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsMR. 7 SUPER 700000 capsules, 1 capsule blister card, Distributed by mR. 7
StuffbyNainax
FDA DrugsClass I
MR. 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
Mar 11, 2026StuffbyNainax
PharmaceuticalFDA Drugs
FDA DrugsSemaglutide Inj, 2mg x 10, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-001-07.
New Life Pharma LLC
FDA DrugsClass II
Semaglutide 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
Mar 11, 2026New Life Pharma LLC
PharmaceuticalFDA Drugs
FDA DrugsGreen Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
ACME UNITED CORPORATION
FDA DrugsClass II
Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%), 25 wipes per box, Distributed by Green Guard, St. Louis, MO 63045, NDC 47682-056-73
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceFDA Devices
FDA DevicesCS100 IABP. Software Version CS100 IABP Q.01.
Datascope Corp.
FDA DevicesClass II
CS100 IABP. Software Version CS100 IABP Q.01.
The firm has identified that the battery runtime and cycle specifications contained in the devices Instructions for Use (IFU) need to be updated.
Mar 11, 2026Datascope Corp.
PharmaceuticalFDA Drugs
FDA DrugsTirzepatide Inj, 10mg, Sterile Multi-Dose Vial, Rx only, Nomida, 25055 W Valley Pkwy, Suite 106, Olathe, KS 66061, NDC 84223-002-03.
New Life Pharma LLC
FDA DrugsClass II
Tirzepatide 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
Mar 11, 2026New Life Pharma LLC
PharmaceuticalFDA Drugs
FDA DrugsSodium 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.
Radnostix
FDA DrugsClass II
Sodium 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
Mar 11, 2026Radnostix
Medical DeviceFDA Devices
FDA DevicesEsaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
ESAOTE S.P.A.
FDA DevicesClass II
Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038
A potential weakness has been identified in the probe body, so that, in a specific production batch, liquid may leak from the terminal part of the casing near the cable.
Mar 11, 2026ESAOTE S.P.A.
Medical DeviceFDA Devices
FDA DevicesImpella RP Flex with SmartAssist. Product Code: 1000323.
Abiomed, Inc.
FDA DevicesClass I
Impella RP Flex with SmartAssist. Product Code: 1000323.
Differential pressure (dP) sensor in Impella RP devices may malfunction, causing sensor values to drift.
Mar 11, 2026Abiomed, Inc.
Medical DeviceFDA Devices
FDA DevicesOlympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Single use Biopsy Valve. Model/Catalog Number: MAJ-210. 20 units per box. The MAJ-210 has been designed to be attached to the instrument channel port of compatible endoscopes to prevent reflux of body fluids.
Potential for rubber fragment detachment during use.
Mar 11, 2026Olympus Corporation of the Americas
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
Food & BeverageFDA Food
FDA FoodPremium Food Bubble Gum, packed in 2.5 oz clear flexible plastic packaging, all lots and codes. Sold in unit case of 30 LB.
Bader Enterprises, Inc.
FDA FoodClass II
Premium 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).
Mar 11, 2026Bader Enterprises, Inc.
Food & Beverage
RappelConso
RappelConsorenault trucks - master iii van de passagers
renault trucks
RappelConsoGeneral Alert
renault trucks - master iii van de passagers
la non-activation du module de distribution d'urée (udm) empêche l'ajout d'urée au système, ce qui entraîne une corrosion potentielle de l'injecteur d'urée et l'absence d'avertissement du tableau de bord ou d'indication du niveau d'urée.
Mar 11, 2026renault trucks
Food & BeverageRappelConso
RappelConsoainomi - multi-position ergonomic baby carrier porte-bébé
ainomi
RappelConsoGeneral Alert
ainomi - multi-position ergonomic baby carrier porte-bébé
les ouvertures des jambes du produit sont trop grandes et la capacité de fixation est insuffisante, ce qui peut entraîner le bébé à glisser, tomber et subir des blessures graves.
Mar 11, 2026ainomi
Food & BeverageRappelConso
RappelConsopaw patrol - sable image pat patrouille 4xp1
paw patrol
RappelConsovolontaire (san...
paw patrol - sable image pat patrouille 4xp1
le jouet présente un risque pour la santé en raison de la présence d'amiante
Mar 11, 2026paw patrol
PharmaceuticalFDA Drugs
FDA DrugsDynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
ACME UNITED CORPORATION
FDA DrugsClass II
Dynarex Obstetrical Towelettes Cleanser (Benzalkonium Chloride 0.13%), 100 packets, 5" x 7", Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA Made in USA, NDC 67777-244-02
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsFIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
HTO Nevada Inc. dba Kirkman
FDA DrugsClass II
FIVE-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.
Mar 11, 2026HTO Nevada Inc. dba Kirkman
PharmaceuticalFDA Drugs
FDA DrugsHand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
ACME UNITED CORPORATION
FDA DrugsClass II
Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 1000 per case, Acme United Corporation, 2280 Tanner Road, Rocky Mount, NC 27801, NDC 0924-0301-00
CGMP Deviations
Mar 11, 2026ACME UNITED CORPORATION
PharmaceuticalFDA Drugs
FDA DrugsNilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Cipla USA, Inc.
FDA DrugsClass III
Nilotinib Capsules, 150 mg per capsule, packaged in cartons, Rx only, Manufactured by: Cipla Ltd., Verna, Goa, India, Manufactured for: Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059, Outer carton: 112 capsules (4 individual packs containing 28 capsules each) NDC 69097-031-74; Inner carton: 28 capsules (4 blisters of 7 capsules) NDC 69097-031-56; Foil blister: NDC 69097-031-17
Failed Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
Mar 11, 2026Cipla USA, Inc.
Food & BeverageRappelConso
RappelConsosans marque - crevettes cuites 30/50
sans marque
RappelConsovolontaire (san...
sans marque - crevettes cuites 30/50
présence de salmonelles
Mar 11, 2026sans marque