Vereinigte Staaten Recalls

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

AVID Medical, Inc.

Feb 18, 2026AVID Medical, Inc.

Halyard TRANSPORT BAG KIT. Kit Code: LIFE0080-01.

Tyvek bag seal issue which may compromise sterility of the kit.

Philips North America Llc

IQon Spectral CT; Product Code (REF): 728332;

Feb 18, 2026Philips North America Llc

IQon Spectral CT; Product Code (REF): 728332;

As part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these fasteners may not be torqued to specification. If multiple fasteners are not torqued to specification, the rotor or rotor parts may become unsecured or displaced. While there has been no reported or observed event of expelled parts during gantry rotation, unsecured rotor parts may potentially be expelled.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Feb 18, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 5 M20 System Model Numbers: (1)722228, (2)722232, (3)722281(OUS only); Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Feb 18, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

Azurion 7 B12 System Model Numbers:(1) 722067, (2) 722225, (3) 722235; Software Version Number - All versions: R1.X, R2.X, R3.X

Under certain conditions, the table may move unexpectedly when the Reset Geometry button is pressed - even when a table lock is active.

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

FDA DevicesClass I

Reprocessed St. Jude Supreme and Response Diagnostic Electrophysiology Catheters: St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 2-5-2mm 401211RH 401222RH 401223RH 401226RH 401227RH 401260RH 401261RH 401306RH 401309RH 401312RH 401430RH 401433RH 401435RH 401441RH 401442RH 401443RH 401448RH 401449RH 401450RH 401451RH 401474RH 401860RH 401877RH 401878RH 401890RH 401891RH 401994RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5-5-5mm 402012RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 4 Elec. 5mm 402004RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 2-5-2mm 402010RH; St. Jude Medical Supreme Diagnostic Electrophysiology Catheter 6 Elec. 5-5-5mm 402008RH 402009RH

These lots of reprocessed catheters may contain small particles of residual material. If affected devices are used, there is a risk of inflammatory response, systemic infection, or granulomatous reaction or thrombus reaction which may lead to cerebral or pulmonary embolism, or deep vein thrombosis. Expansion of recall Z-2610/2614-2025

Feb 18, 2026Domino Foods Inc

Sodexo Stars Saccharin (Pink) Packets, Sugar Substitute, Net Wt 0.035 oz. (1g), Manufactured by Domino Foods, Inc., West Palm Beach, FL 33041

Domino Foods Inc

FDA FoodClass III

Sodexo Stars Saccharin (Pink) Packets, Sugar Substitute, Net Wt 0.035 oz. (1g), Manufactured by Domino Foods, Inc., West Palm Beach, FL 33041

Undeclared Aspartame

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone, 18.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1018-32.

Presence of Foreign substance - potential presence of metal particulate matter

Karison Foods & Snacks, Inc.

Karison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shortening; UPC: 8 97307 00251 2; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.

Feb 18, 2026Karison Foods & Snacks, Inc.

Karison brand ALSI PINNI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Sugar Flax Seeds, Almonds, Zero Trans Fat, Vegetable Shortening; UPC: 8 97307 00251 2; Distributed By: Karison Foods & Snacks Inc.; 34 Willowdale Ave., Port Washington, NY 11050; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.

Product contains milk, which is undeclared in the ingredient statement.

Costco Wholesale Corporation

Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.

FDA FoodClass I

Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT. UPC 000011 812722. Product is packaged in a clear clamshell container. ALLERGENS INFORMATION: CONTAINS WHEAT, EGG, MILK, SOY. Distributed by Costco Wholesale Corp. PO Box 34535 Seattle, WA.

Undeclared hazelnut.

Feb 18, 2026Costco Wholesale Corporation

Karison Foods & Snacks, Inc.

Karison brand NO SUGAR ADDED BESAN LADDOO; Ingredients: Gram Flour, Butter, Zero Trans Fat Vegetable Shortening (Hydrogenated Soybean Oil), Pistachio, Almonds, Sweetener with Nutrasweet; UPC: 8 97397 00221 5; Distributed By: Karison Foods & Snacks, Inc, 34 Willowdale Ave., Port Washington, N.Y. 11050; NET WT. 12 oz.; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.

Feb 18, 2026Karison Foods & Snacks, Inc.

Karison brand NO SUGAR ADDED BESAN LADDOO; Ingredients: Gram Flour, Butter, Zero Trans Fat Vegetable Shortening (Hydrogenated Soybean Oil), Pistachio, Almonds, Sweetener with Nutrasweet; UPC: 8 97397 00221 5; Distributed By: Karison Foods & Snacks, Inc, 34 Willowdale Ave., Port Washington, N.Y. 11050; NET WT. 12 oz.; Manufactured in a facility that processes Milk, Eggs, Soybean, Tree nuts, Wheat, Peanuts and other Nuts. Product is packaged in clear plastic containers, 12-(12 oz) units/case.

Product contains milk, which is undeclared in the ingredient statement.

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone 75mg, Anastrozole 4mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-4079-32.

Presence of Foreign substance - potential presence of metal particulate matter

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

Medline medical convenience kits packaged as: BLOOD CULTURE KIT NS, Kit SKU DYNDH2088

Medline Industries, LP is issuing a recall for specific items and lots of Medline Kits containing BD ChloraPrep Triple Swabsticks which BD determined may exhibit an open seal on the packaging of the applicators.

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.

Medline medical convenience kits packaged as: 1) CANCER SERVICE PORT KIT, Kit SKU DT22710; 2) LINE KIT, Kit SKU DYNDA1857A; 3) PICC REMOVAL KIT, Kit SKU DYNDC1978A; 4) PORT ACCESS TRAY, Kit SKU DYNDC2367; 5) NICU CENTRAL LINE TRAY, Kit SKU DYNDC2407B; 6) CVC DRESSING CHANGE W/ TEG CHG, Kit SKU DYNDC3222A; 7) PICC PROCEDURE PACK, Kit SKU DYNJ59067A; 8) PICC PROCEDURE PACK, Kit SKU PHS950205004B.

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

Alphatec Spine, Inc.

Feb 18, 2026Alphatec Spine, Inc.

ATEC Lateral Navigation Disc Prep Instruments LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N UDI-DI code: 00190376476179; GMDN 12844 The ATEC Navigation Disc Prep Instruments are intended for use in surgical procedures. These instruments are non-sterile or sterile packaged, re-usable or single-use instruments designed to function with the Medtronic StealthStation System and NavLock Tracker.

Due a design issue where the navigated array connection geometry is incorrect.

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

Elekta, Inc.

Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment planning system Software Version: 11.1 Product Description: Leksell GammaPlan¿ is a computer-based system designed for Leksell Gamma Knife¿ treatment planning.

Due to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan reference. This may result in a treatment plan that potentially irradiates the incorrect patient location if the error is not detected by users.

Feb 18, 2026Elekta, Inc.

Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

Steris Corporation

Feb 18, 2026Steris Corporation

Barco MNA with the HexaVue IP Integration System, Model/Catalog Number: MNA-6x0-H

This is a sub-recall of event RES 96885. The supplier identified that during their manufacturing process for a limited batch of MNA-6x0 (adapter) components the incorrect configuration file was used.

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

Medline medical convenience kits packaged as: ) LVAD DRESSING CHANGE TRAY, Kit SKU DM320C; 2) PORT AND IO ACCESS DRESSING KI, Kit SKU DT15780A; 3) PORT-A-CATH DRESSING CHANGE TR, Kit SKU DT16615; 4) LARGE BORE CENTRAL LINE DRSG C, Kit SKU DT19660; 5) CENTRAL LINE DRESSING CHANGE K, Kit SKU DT19665; 6) NEONATAL DRESSING CHANGE KIT, Kit SKU DT21495; 7) NICU CVC DRESSING CHANGE TRAY, Kit SKU DT22510A; 8) DRESSING CHANGE TRAY W/TEG CHG, Kit SKU DYNDC3114B; 9) DRESSING CHANGE KIT, Kit SKU DYNDC3351.

Laerdal Medical Corporation

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

Feb 18, 2026Laerdal Medical Corporation

Laerdal Compact Suction Unit 4 RTCA version (LCSU 4 RTCA) 1) LCSU 4, 800 ml, RTCA; Catalog Number: 880052; 2) LCSU 4, 300 ml, RTCA; Catalog Number: 880062; 3) LCSU 4, RTCA; Catalog Number: 881152;

units manufactured in a limited time period may emit electromagnetic noise beyond the acceptable limits for RTCA application specified in RTCA DO-160G Chapter 21, Equipment Category M.

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

FDA DevicesClass I

Reprocessed Siemens ACUSON AcuNav Diagnostic Ultrasound Catheters: ACUSON AcuNav Ultrasound Catheter, Use on GE Systems 10135910RH; 10043342RH ACUSON AcuNav Ultrasound Catheter, Use on Siemens Systems 10135936RH, 08255790RH

CREAMY PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY US FOODS, ROSEMONT, IL 60018; PEANUT BUTTER NET WT. 0.5OZ & NET WT 0.75OZ DIST BY: DYMA BRANDS, INC. ATLANTA, GA 30328; Product also sold under the following brand names: FLAVOR Fresh PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY: DYMA BRANDS, INC. ATLANTA, GA 30328; HOUSE RECIPE CREAMY PEANUT BUTTER NET WT 0.75 OZ (21.2g) DISTRIBUTED BY SYSCO COROPRATION, HOUSTON, TEXAS 77077; Katy's Kitchen SMOOTH PEANUT BUTTER NET WT 0.75 OZ (21g) MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTIN, TX 77043 PEANUT BUTTER creamy NET WT 0.75 OZ (21g) FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE WYOMING, MI 49509; CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328

Ventura Foods LLC

Feb 18, 2026Ventura Foods LLC

CREAMY PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY US FOODS, ROSEMONT, IL 60018; PEANUT BUTTER NET WT. 0.5OZ & NET WT 0.75OZ DIST BY: DYMA BRANDS, INC. ATLANTA, GA 30328; Product also sold under the following brand names: FLAVOR Fresh PEANUT BUTTER NET WT 0.75 OZ(21g) DISTRIBUTED BY: DYMA BRANDS, INC. ATLANTA, GA 30328; HOUSE RECIPE CREAMY PEANUT BUTTER NET WT 0.75 OZ (21.2g) DISTRIBUTED BY SYSCO COROPRATION, HOUSTON, TEXAS 77077; Katy's Kitchen SMOOTH PEANUT BUTTER NET WT 0.75 OZ (21g) MARKETED BY INDEPENDENT MARKETING ALLIANCE HOUSTIN, TX 77043 PEANUT BUTTER creamy NET WT 0.75 OZ (21g) FOR DISTRIBUTION EXCLUSIVELY BY GORDON FOOD SERVICE WYOMING, MI 49509; CREAMY PEANUT BUTTER NET WT 1.12 OZ(32g) POCO PAC DISTRIBUTED BY DYMA BRANDS, INC. ATLANTA, GA 30328

Foreign material. During production, the firm found pieces of blue plastic in a filter.

Pro Numb Tattoo Numbing Spray LLC

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

Feb 18, 2026Pro Numb Tattoo Numbing Spray LLC

Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML or 4 oz/120 mL] per bottle, Distributed by: Pro Numb Tattoo numbing spray LLC, Melbourne, FL 32907, NDC 83389-112-11

cGMP deviations

Crunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.

Cacao Art

Crunchy Caramel artisan dark chocolate with crunch brown sugar caramel pieces 60% Cacao, NET WT 2 oz (60g), Ingredients *Cocoa Butter, Soy Lecithin (Emulsifier), Butter (Cream, Natural Flavor) CONTAINS: SOY. Garcia Nevett chocolatier de miami, packaged in plastic envelope inside paper envelope, 10 bars per box.

Undeclared allergen - milk. Product contains butter; cream is listed as a sub-ingredient of the butter, but milk is not declared in the ingredients or a contains statement.

Feb 18, 2026Cacao Art

F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

Feb 18, 2026F.H. INVESTMENTS, Inc. (dba Asteria Health)

Testosterone, 62.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1062-32.

Presence of Foreign substance - potential presence of metal particulate matter