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Medical Device
FDA Devices
FDA DevicesProduct Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0730 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3025 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Food & Beverage
RappelConso
RappelConsonamli - domates salcasi
namli
RappelConsovolontaire (san...
namli - domates salcasi
des produits interdits ont été utilisé pour la conception du produit
Feb 11, 2026namli
Food & BeverageFDA Food
FDA FoodRepackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Beacon Promotions Inc
FDA FoodClass II
Repackaged M&Ms Peanut candies, Net Wt 1.3 oz. Item BB471BG. Labeled as Make Your Mark. For nutrition facts information and ingredients, go to https://hpgbrands.com/sugarspot-nutrition/
Undeclared allergens (milk, soy, and peanut)
Feb 11, 2026Beacon Promotions Inc
Food & BeverageFDA Food
FDA FoodSwiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
B.C. Williams Bakery Service, Inc
FDA FoodClass I
Swiss Chocolate Cake Mix; 50 lb. multi-wall, kraft, poly-lined moisture proof bags
Undeclared Milk Allergen
Feb 11, 2026B.C. Williams Bakery Service, Inc
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Orange- UPC# 5061033692926
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
FDA DevicesLH One Step Ovulation Test Device (Urine)
Changchun Wancheng Bio-Electron Co., Ltd.
FDA DevicesClass II
LH One Step Ovulation Test Device (Urine)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Feb 11, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceFDA Devices
FDA DevicesMale Fertility Sperm Test for Home Use (Cassette)
Changchun Wancheng Bio-Electron Co., Ltd.
FDA DevicesClass II
Male Fertility Sperm Test for Home Use (Cassette)
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Feb 11, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Medical DeviceFDA Devices
FDA DevicesProduct Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Wilson-Cook Medical Inc.
FDA DevicesClass II
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
Feb 11, 2026Wilson-Cook Medical Inc.
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Strawberry- UPC# 5065006235271
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Medical DeviceFDA Devices
FDA DevicesNAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Siemens Medical Solutions USA, Inc
FDA DevicesClass II
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Feb 11, 2026Siemens Medical Solutions USA, Inc
Food & BeverageFDA Food
FDA FoodBarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5
Prima Foods International, Inc.
FDA FoodClass III
BarbaCuban Cubama White Truffle Sauce, Net Wt. 12 oz (355 ml). Packed in 12 oz glass bottles and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 7 19660 00190 5
Undeclared Quinine
Feb 11, 2026Prima Foods International, Inc.
Medical DeviceFDA Devices
FDA DevicesVortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Surgical Lindsell Sutured IOL Marker, VS0390 - Scleral Marker
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Lemon Pie- UPC# 5061033691271
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Wildcrafted- UPC# 5065006235073
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc
Food & BeverageFDA Food
FDA FoodGLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6
Rich Products Corp
FDA FoodClass II
GLUTEN FREE 14" SEASONED VEGAN PIZZA CRUST; INGREDIENTS: WATER, RICE FLOUR, POTATO STARCH, RICE STARCH, TAPIOCA STARCH, CANE SUGAR, MODIFIED RICE STARCH, POTATO FLOUR, PEA FIBER, CONTAINS LESS THAN 2% OF THE FOLLOWING: CANOLA OIL, YEAST, SALT, CELLULOSE GEL, EXTRA VIRGIN OLIVE OIL, GARLIC POWDER, SPICES, XANTHAN GUM, CELLULOSE GUM, CULTURED BROW RICE, BROWN RICE FLOUR, CITRIC ACID, LACTIC ACID; MAY CONTAIN MILK AND EGGS; MANUFACTURED BY VENCE BAKERY; Net Case Wt: 14 LB 6 OZ (6.52 KG); Unit Net Wt: 11.5 OZ (326 G); COUNT: 20; KEEP FROZEN; GTIN code on shipper case (01) 0 0859955 00412 6
Product contains undeclared milk and egg
Feb 11, 2026Rich Products Corp
Food & BeverageFDA Food
FDA FoodLost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Fazt & Loud LLC
FDA FoodClass III
Lost and Found Energy, Sour Gummy Bear, 12pck, 16oz Cans Case UPC: 850075595655 Can UPC: 850075595662 Aluminum Can Packaged
Recall is due to a misprint on the label that incorrectly identifies the total caffeine content on the can. The item contains 300mg of caffeine, instead of 150mg as provided on the can.
Feb 11, 2026Fazt & Loud LLC
Medical DeviceFDA Devices
FDA DevicesVivoo pH Test
Changchun Wancheng Bio-Electron Co., Ltd.
FDA DevicesClass II
Vivoo pH Test
Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.
Feb 11, 2026Changchun Wancheng Bio-Electron Co., Ltd.
Food & BeverageFDA Food
FDA FoodBarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7
Prima Foods International, Inc.
FDA FoodClass III
BarbaCuban Ram Air Red Zesty Ketchup, Net Wt. 12 oz (355 ml) 12 oz glass bottles, and 1 gallon HDPE Industrial Plastic Jugs, ¿ gallon HDPE Industrial Plastic Jugs. packaged in 12x12 fl oz, 6x12 fl oz, 4x1 gallon, 4x1/2 gallons. UPC code 0 07196 60000 7
Undeclared Quinine
Feb 11, 2026Prima Foods International, Inc.
Medical DeviceFDA Devices
FDA DevicesVortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
Vortex Surgical Inc.
FDA DevicesClass II
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Cannula-Bulk VS0200.25B 15. 27GA Soft Tip Cannula VS0200.27
There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Feb 11, 2026Vortex Surgical Inc.
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodBread Crumbs, Outside The Breadbox brand, net wt. 8 oz, UPC 873799001554. Product is packaged in a clear stand up pouch. Intended use baking. Condition/Shelf Life shelf stable, 180 days. Firm name Outside The Breadbox, 2027 W Colorado Ave. Colorado Springs, CO.
VH FOODS INC
FDA FoodClass I
Bread Crumbs, Outside The Breadbox brand, net wt. 8 oz, UPC 873799001554. Product is packaged in a clear stand up pouch. Intended use baking. Condition/Shelf Life shelf stable, 180 days. Firm name Outside The Breadbox, 2027 W Colorado Ave. Colorado Springs, CO.
Undeclared allergens: egg and milk
Feb 11, 2026VH FOODS INC
Medical DeviceFDA Devices
FDA DevicesProduct Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Olympus Corporation of the Americas
FDA DevicesClass II
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1520 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Devices which did not undergo thermoforming could deform and lose performance.
Feb 11, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodSea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
Diva Fam Inc
FDA FoodClass II
Sea Moss Gel Superfood; 16 FL OZ; Glass jar sold individually. Passion Fruit- UPC# 5061033691882
potential Clostridium botulinum contamination
Feb 11, 2026Diva Fam Inc