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PharmaceuticalUSFDA Drugs

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

ACME UNITED CORPORATION
FDA DrugsClass II

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, 2026ACME UNITED CORPORATION
Vehicle RecallUSNHTSA

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.
Food & BeverageUSFDA Food

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

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
PharmaceuticalUSFDA Drugs

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.

Mar 11, 2026Cipla USA, Inc.
PharmaceuticalUSFDA Drugs

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.

The Harvard Drug Group LLC
FDA DrugsClass II

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.

Mar 11, 2026The Harvard Drug Group LLC
PharmaceuticalUSFDA Drugs

Hand 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
Medical DeviceUSFDA Devices

Esaote 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 DeviceUSFDA Devices

CS100 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.
PharmaceuticalUSFDA Drugs

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

ACME UNITED CORPORATION
FDA DrugsClass II

First Aid Only BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%) 100 Wipes, NDC 0924-7116-04

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceUSFDA Devices

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

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 DeviceUSFDA Devices

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 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
PharmaceuticalUSFDA Drugs

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

ACME UNITED CORPORATION
FDA DrugsClass II

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

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
Safety AlertCanadaHealth Canada

Baixiang brand Artificial Spicy Beef Soup Flavor Instant Noodles recalled due to undeclared peanut

CFIA
Health CanadaClass 2

Baixiang brand Artificial Spicy Beef Soup Flavor Instant Noodles recalled due to undeclared peanut

Peanut

Mar 11, 2026CFIA
Medical DeviceAustraliaAustralia

Rifton TRAM and E-Pacer patient transfer and gait training devices

TGAAustralia
au-tgaMedical Device ...

Rifton TRAM and E-Pacer patient transfer and gait training devices

Apex Mobility is conducting a product correction on the Rifton TRAM and E-Pacer patient transfer and gait training mobility devices....

Mar 11, 2026TGA
Medical DeviceAustraliaAustralia

TRUE METRIX® Blood Glucose Monitoring Systems

TGAAustralia
au-tgaMedical Device ...

TRUE METRIX® Blood Glucose Monitoring Systems

The former liquidator for Trividia Health Australia Pty Ltd (deregistered) is facilitating a product correction for TRUE METRIX® Blood Glucose Monitoring Systems....

Mar 11, 2026TGA
Medical DeviceUSFDA Devices

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
FDA DevicesClass II

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
Medical DeviceUSFDA Devices

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 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
Medical DeviceUSFDA Devices

EVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5

Staar Surgical AG
FDA DevicesClass II

EVO+ 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.

Mar 11, 2026Staar Surgical AG
PharmaceuticalUSFDA Drugs

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

ACME UNITED CORPORATION
FDA DrugsClass II

Med Nap BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 100 Towelettes, Manufactured by: Acme United Corporation, 1 Waterview Dr, Shelton, CT 06481, NDC 0924-0246-01.

CGMP Deviations

Mar 11, 2026ACME UNITED CORPORATION
Medical DeviceUSFDA Devices

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.

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
Food & BeverageUSFDA 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
Medical DeviceUSFDA Devices

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.
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 DeviceUSFDA Devices

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

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 AlertCanadaHealth Canada

Transport Canada Recall - 2026098 - FORD

TC
Health CanadaGeneral Alert

Transport Canada Recall - 2026098 - FORD

Visual System

Mar 11, 2026TC
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