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Medical DeviceUSFDA Devices

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.
FDA DevicesClass II

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.

Feb 18, 2026Alphatec Spine, Inc.
Medical DeviceUSFDA Devices

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

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II

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.

Feb 18, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceUSFDA Devices

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

Medline Industries, LP
FDA DevicesClass II

Medline medical convenience kits packaged as: PEDIATRIC CATH SECUREMENT DRSG, Kit SKU DYNDC3108

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.

Feb 18, 2026Medline Industries, LP
Food & BeverageUSFDA Food

a.) Preema brand Bright Red Food Colour Powder; Net Weight .88oz/25gm; packaged in small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children b.) Preema brand Orange Food Colour Powder; Net Weight .88oz/25gm; packaged in a small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children

KPCM New York Inc.
FDA FoodClass II

a.) Preema brand Bright Red Food Colour Powder; Net Weight .88oz/25gm; packaged in small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children b.) Preema brand Orange Food Colour Powder; Net Weight .88oz/25gm; packaged in a small plastic bottle; INGREDIENTS: SODIUM CHLORIDE, COLOUR (TARTRAZINE, CARMOSINE, ALLURA RED) CHECK THE LEGAL LIMIT, CONTAINS NO ANIMAL MATTER. E102, E122, E129 may have an adverse effect on activity and attention in children

Products contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40

Feb 18, 2026KPCM New York Inc.
Food & BeverageUSFDA Food

Smoked Grouper Dip 7lb plastic tub with tamper proof lid 1/7lb tub per case. Keep Refrigerated.

ISLAND CRAB CORPORATION
FDA FoodClass II

Smoked Grouper Dip 7lb plastic tub with tamper proof lid 1/7lb tub per case. Keep Refrigerated.

Undeclared Milk, Eggs, Sodium metabisulfite

Feb 18, 2026ISLAND CRAB CORPORATION
Medical DeviceUSFDA Devices

Brilliance iCT; Product Code (REF): 728306;

Philips North America Llc
FDA DevicesClass II

Brilliance iCT; Product Code (REF): 728306;

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.

Feb 18, 2026Philips North America Llc
PharmaceuticalUSFDA Drugs

ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

ESTRADIOL, 22 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3022-32.

Presence of Foreign substance - potential presence of metal particulate matter

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

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

Unichem Pharmaceuticals USA Inc.
FDA DrugsClass III

Doxazosin Tablets, USP, 4 mg, 1000 tablets per bottle, Rx only, distributed by Unichem Pharmaceuticals (USA), Inc., 1 Tower Center Boulevard, Suite 2200, East Brunswick, NJ 08816 USA, manufactured by Unichem Laboratories Limited, Plot Number 15 to 18, Pilerne Industrial Estate, Pilerne, Bardez, Goa (India) 403511, NDC 29300-353-10.

Tablets/Capsules Imprinted with Wrong ID

Feb 18, 2026Unichem Pharmaceuticals USA Inc.
Food & BeverageUSFDA Food

Karison brand PANJIRI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Almonds, Sugar, Lotus Seeds, Fennel Seeds, Flax Seeds, Edible Gum, Ginger Powder, Zero Trans Fat Vegetable Shortening; UPC: 8 97307 00243 7; 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.

Karison Foods & Snacks, Inc.
FDA FoodClass II

Karison brand PANJIRI; NET WT. 12 oz.; Ingredients: Wheat Flour, Butter, Almonds, Sugar, Lotus Seeds, Fennel Seeds, Flax Seeds, Edible Gum, Ginger Powder, Zero Trans Fat Vegetable Shortening; UPC: 8 97307 00243 7; 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.

Feb 18, 2026Karison Foods & Snacks, Inc.
Food & BeverageGermanyGermany BVL

Stretch Squad dehnbare Figuren | Stretch Squad Figuren vier Stück

Vulcan Consulting, 38/39 Fitzwilliam Square West, Dublin 2, D02 NX53, Irland
Germany BVLGeneral Alert

Stretch Squad dehnbare Figuren | Stretch Squad Figuren vier Stück

Gesundheitsschädliche Substanz

Feb 18, 2026Vulcan Consulting, 38/39 Fitzwilliam Square West, Dublin 2, D02 NX53, Irland
Food & BeverageUSFDA Food

Brand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores

Lee's Commissary
FDA FoodClass II

Brand: Red Button Movie House Popcorn Pack Size: 24 oz. / 680g. SKU/UPC:4117281332 Shelf life: 150 days. Packaging: Plastic bag Production location: Lee s Commissary 888 W 1600 S Unit 130, Logan Ut. 84321 Distributed by: Associated Food Stores

Product may contain foreign material.

Feb 18, 2026Lee's Commissary
PharmaceuticalUSFDA Drugs

Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

Testosterone, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1037-32.

Presence of Foreign substance - potential presence of metal particulate matter

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

Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

Testosterone, 50.0 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-1050-32.

Presence of Foreign substance - potential presence of metal particulate matter

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

Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

Testosterone 200mg, Triamcinolone Acetonide 40mcg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-6200-43.

Presence of Foreign substance - potential presence of metal particulate matter

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

ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

ESTRADIOL,15 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3015-32.

Presence of Foreign substance - potential presence of metal particulate matter

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

Spicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.

MG Foods-Compass Group
FDA FoodClass II

Spicy Breakfast Burrito in a flour tortilla. Net Weight 10 oz (283g) Scrambled eggs, Salsa, Potatoes, Jalapenos, Cheddar, Green Pepper & Onion. UPC 1 00001-00029 7. Keep Refrigerated. Manufactured By: MG Foods, Oak Creek, WI 53154.

foreign material (small hard plastic fragments)

Feb 18, 2026MG Foods-Compass Group
Food & BeverageUSFDA Food

Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.

Carrot Top Kitchens LLC
FDA FoodClass I

Carrot Top Kitchens Cherry Pepper Hummus; contains chickpeas, tahini, pickled cherry peppers, vinegar, garlic, salt; 8 oz.

Contains undeclared sesame

Feb 18, 2026Carrot Top Kitchens LLC
Medical DeviceUSFDA Devices

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

AVID Medical, Inc.
FDA DevicesClass II

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

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

Feb 18, 2026AVID Medical, Inc.
Medical DeviceUSFDA Devices

Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.

Medline Industries, LP
FDA DevicesClass II

Medline medical convenience kits packaged as: 1) POWERGLIDE DRESSING CHANGE KIT, Kit SKU DYNDH1576; 2) CENTRAL LINE TRAY W/ CHLRP SWB, Kit SKU RWM-DC57KC.

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.

Feb 18, 2026Medline Industries, LP
Medical DeviceUSFDA Devices

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; Software Version Number - All versions: R1.X, R2.X, R3.X

PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
FDA DevicesClass II

Azurion 3 M12 System Model Numbers: (1) 722063, (2) 722221, (3) 722229; 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.

Feb 18, 2026PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Medical DeviceUSFDA Devices

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

Medline Industries, LP
FDA DevicesClass II

Medline medical convenience kits packaged as: SUTURE REMOVAL TRAY, Kit SKU DYNDR1277A

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.

Feb 18, 2026Medline Industries, LP
Medical DeviceUSFDA Devices

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

Medline Industries, LP
FDA DevicesClass I

Reprocessed Livewire Steerable Diagnostic Electrophysiology Catheters: Livewire Steerable Electrophysiology Catheter,10 Elec. 2-5-2mm 401582RH 401940RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-10-2mm 401904RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-5-2mm 401914RH; Livewire Steerable Electrophysiology Catheter,20 Elec. 2-8-2-60-2-8-2mm 401932RH; Livewire Steerable Electrophysiology Catheter,8 Elec. 2-2-2mm 401652RH;

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, 2026Medline Industries, LP
PharmaceuticalUSFDA Drugs

ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

F.H. INVESTMENTS, Inc. (dba Asteria Health)
FDA DrugsClass II

ESTRADIOL, 37.5 mg, 1 Sterile Pellet, Asteria Health 432 Industrial Ln, Birmingham, AL 35211, NDC: 79559-3037-32.

Presence of Foreign substance - potential presence of metal particulate matter

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

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Hologic, Inc
FDA DevicesClass II

Brevera Breast Biopsy System Disposable 9 Gauge Needle. Biopsy Instrument.

Presence of particulates in affected devices that can be deposited into breast tissue during use.

Feb 18, 2026Hologic, Inc
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