Safety Recall Directory
Browse and filter the latest official safety alerts globally.
FDA DrugsDynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
Dynarex, BZK Antiseptic Towelettes (Benzalkonium Chloride 0.13%), 5x7, 1000 packets, 5x7, Manufactured for Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962,USA, NDC 67777-245-04.
CGMP Deviations
NHTSAAluminum Trailer Company (ATC) - Carbon Monoxide May Enter the Passenger Cabin
Aluminum Trailer Company (ATC) - Carbon Monoxide May Enter the Passenger Cabin
Exhaust fumes inside the cabin increase the risk of injury or death from carbon monoxide poisoning.
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.
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.
FDA DrugsWP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
WP WipesPlus Hand Sanitizing Wipes (Benzalkonium Chloride 0.13%), 5x7, 100 CT, Progressive Products, 211 S. Ridge Street, Rye Brook, NY 10573. NDC 67151-727-01.
CGMP Deviations
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
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.
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.
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.
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.
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.
FDA DrugsMed 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.
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
FDA DevicesEVO+ Visian Toric Implantable Collamer Lens (TICL), Model: VTICM5
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.
FDA DevicesBrand 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
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.
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
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.
FDA FoodJunebar 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
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.
FDA DrugsSILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
SILINTAN 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.
NHTSAVolkswagen Group of America, Inc. - Loose Transmission Ground Wire May Cause Fire
Volkswagen Group of America, Inc. - Loose Transmission Ground Wire May Cause Fire
An open circuit may draw a higher current and increase the risk of a fire.
Health CanadaTransport Canada Recall - 2026100 - FORD
Transport Canada Recall - 2026100 - FORD
Visual System
Health CanadaTransport Canada Recall - 2026098 - FORD
Transport Canada Recall - 2026098 - FORD
Visual System
Health CanadaTransport Canada Recall - 2026102 - GENERAL MOTORS
Transport Canada Recall - 2026102 - GENERAL MOTORS
Fuel System
Health CanadaTransport Canada Recall - 2026104 - GENERAL MOTORS
Transport Canada Recall - 2026104 - GENERAL MOTORS
Tires
Health CanadaTransport Canada Recall - 2026097 - FORD
Transport Canada Recall - 2026097 - FORD
Powertrain
Health CanadaTransport Canada Recall - 2023415 - AIRSTREAM
Transport Canada Recall - 2023415 - AIRSTREAM
Electrical
FSANZ FoodFamily Select Pty Ltd - Frozen Sorbet Mango 75g, Strawberry 75g and Lychee 75g
Family Select Pty Ltd - Frozen Sorbet Mango 75g, Strawberry 75g and Lychee 75g
The recall is due to the presence of an undeclared allergen (milk).
Health CanadaTransport Canada Recall - 2026096 - FORD
Transport Canada Recall - 2026096 - FORD
Other
Health CanadaTransport Canada Recall - 2026095 - FORD
Transport Canada Recall - 2026095 - FORD
Seats And Restraints
Health CanadaTransport Canada Recall - 2026094 - FORD
Transport Canada Recall - 2026094 - FORD
Engine