États-Unis Recalls

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

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

Teva Pharmaceuticals USA, Inc

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Mar 11, 2026Teva Pharmaceuticals USA, Inc

Metoprolol Succinate Extended-Release Tablets, Rx Only, 100 mg, 100 tablets bottles (NDC: 45963-677-11) and 1,000 tablets bottles (NDC: 45963-677-96), Teva Pharmaceuticals, Parsippany, NJ 07054.

Failed Dissolution Specifications

Teva Pharmaceuticals USA, Inc

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Mar 11, 2026Teva Pharmaceuticals USA, Inc

Metoprolol Succinate Extended-Release Tablets, 50 mg, 100 tablets bottles (NDC: 45963-676-11) and 1,000 tablets bottles (NDC: 45963-676-96), Rx Only, Teva Pharmaceuticals, Parsippany, NJ 07054

Failed Dissolution Specifications

The Harvard Drug Group LLC

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

Mar 11, 2026The Harvard Drug Group LLC

Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.

Defective container; inadequately sealed blister packaging.

Vehicle Recall

NHTSA

Mack Trucks, Inc. - ECU Software Error May Cause Unexpected Vehicle Movement/FMVSS 102

Mack Trucks, Inc.

NHTSAENGINE AND ENGI...

Mack Trucks, Inc. - ECU Software Error May Cause Unexpected Vehicle Movement/FMVSS 102

Starting the vehicle while in gear may cause unexpected vehicle movement, increasing the risk of a crash or injury.

Mar 11, 2026Mack Trucks, Inc.

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

Children's Healthcare of Atlanta, Instant Hand Sanitizing Wipe(Benzalkonium Chloride 0.13%), 1000 per case, Made in USA for Food Service Resources, Flowery Branch, GA 30542, NDC 0924-7130-00

CGMP Deviations

Mar 11, 2026Cipla USA, Inc.

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

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.

Semaglutide 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

New Life Pharma LLC

Mar 11, 2026New Life Pharma LLC

Semaglutide 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

Mar 11, 2026Abiomed, Inc.

Impella 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.

Esaote Endocavity ultrasonic probe, Model E 3-12, REF 120000038

ESAOTE S.P.A.

Mar 11, 2026ESAOTE S.P.A.

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.

CS100 IABP. Software Version CS100 IABP Q.01.

Datascope Corp.

Mar 11, 2026Datascope Corp.

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.

GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-039, 2110344-046, 2110344-047; System, Image Processing, Radiological

GE Healthcare

Mar 11, 2026GE Healthcare

GE 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,

Food & Beverage

FDA Food

Junebar 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 PEANUT, SESAME, PRODUCED IN A FACILITY THAT ALSO PROCESSES GLUTEN PRODUCTS. KEEP REFRIGERATED.; UPC 8 60012 38461 7

Juniper Granola, LLC

FDA FoodClass I

Junebar 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 PEANUT, SESAME, PRODUCED IN A FACILITY THAT ALSO PROCESSES GLUTEN PRODUCTS. KEEP REFRIGERATED.; UPC 8 60012 38461 7

Products contain undeclared milk and soy.

Mar 11, 2026Juniper Granola, LLC

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.

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.

Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.

Antimicrobial Alcohol Hand Wipe, Isopropyl Alcohol 70%, Manufactured for : Custom Packaging Co., Inc, Louisville, KY 4023, NDC 0924-251-00.

CGMP Deviations

HTO Nevada Inc. dba Kirkman

FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.

Mar 11, 2026HTO Nevada Inc. dba Kirkman

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.

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.

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.

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.

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.

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.

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.

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01

Max Packaging Antibacterial Towelette (Benzalkonium Chloride 0.13%), 1 towelette, 4x7, Max Packaging, Made in the USA, NDC 59647-750-01

CGMP Deviations

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) 1000 Packs per case, Manufactured For: Dukal, LLC, Ronkonkoma, NY 11779, Made in USA, NDC 65517-0004-1

CGMP Deviations

Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

Aesculap Inc

Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R Software Version: N/A Product Description: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Component: N/A

There is the potential for the length of the trocar shaft to be too long.

Mar 11, 2026Aesculap Inc

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

Diagnostica Stago, Inc.