Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Showing 24 of 17,563 results
Pharmaceutical
FDA Drugs
FDA DrugsVista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Food & BeverageFDA Food
FDA FoodFish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
FDA FoodClass I
Fish Ball, Frozen, 40 pieces per pack, 200g Wt. UPC# 810093891338
Undeclared allergen ingredient (Wheat and Sesame)
Mar 4, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
Medical DeviceFDA Devices
FDA DevicesAdapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti Health - Ellis
FDA DevicesClass II
Adapt Pump, Model/Catalog Number: 61600200-Adapt Pump, component of Adapt support surfaces (Adapt Air, Adapt Air EX, Adapt Air Pro, Adapt Air Pro EX, Adapt Convertible, Adapt Convertible EX), sofware version 1.3.0; Mattress, Air Flotation, Alternating Pressure
Agiliti identified an issue where the Adapt Pump (61600200-Adapt Pump) supplied with all Adapt Line support surfaces does not re-engage the Microclimate Management function after using the Autofirm function for 10 minutes. This issue only occurs when the 10-minute timer is allowed to elapse after the Autofirm button is pressed after initial setup, and it only affects the Microclimate Management function.
Mar 4, 2026Agiliti Health - Ellis
Food & BeverageFDA Food
FDA FoodPrime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000
Prime Food Processing LLC.
FDA FoodClass I
Prime Food Processing Dried Croaker Fish; NET WT: 8oz (227g); Ingredients: Croaker Fish, Salt; CONTAINS: FISH (CROAKER FISH); DISTRIBUTED BY: PFP LLC, Brooklyn, NY, 11211, USA; Product must be thoroughly cleaned and cooked before consumption.; PRODUCT OF VIETNAM; UPC: 6 946976 818000
Uneviscerated Fish
Mar 4, 2026Prime Food Processing LLC.
Food & BeverageFDA Food
FDA FoodFish Ball, Frozen, 4 pieces per pack, 5lbs Wt. UPC# 810093891320
MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
FDA FoodClass I
Fish Ball, Frozen, 4 pieces per pack, 5lbs Wt. UPC# 810093891320
Undeclared allergen ingredient (Wheat and Sesame)
Mar 4, 2026MIN JIANG FOOD STORE INC DBA KOI KOI TRADING
Food & BeverageFDA Food
FDA FoodValley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Valley Springs Artesian Gold, LLC
FDA FoodClass II
Valley Springs 100% Natural Bottled Water packaged in the following size plastic jug with plastic caps: 1. 1 Gal Net 128 Fl oz. UPC 0 31193-00701 9. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 2. 2.5 Gallon Net (320 Fl oz./9.4L). UPC 0 31193-01501 4. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. 3. Infant Water, 1 Gal Net, 128 FL. Oz. Not sterile. Use as directed by physician or by labeling directions for use of infant formula. UPC 0 31193-01401 7. 4. Daisy's Doggy Water, 1 Gal Net, 128 FL. Oz. 100% Pure Water. No Chlorine. UPC 0 31193-90100 3. Bottled by Valley Springs/Artesian Gold, LLC, Portage WI 53901. Distributed by DDW LLC, 109 S. Thompson Rd., Sun Prairie, WI 53590.
Water was bottled under insanitary conditions.
Mar 4, 2026Valley Springs Artesian Gold, LLC
Medical DeviceFDA Devices
FDA DevicesConvenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Medline Industries, LP
FDA DevicesClass II
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
Mar 4, 2026Medline Industries, LP
Food & BeverageFDA Food
FDA FoodWellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
SLADE GORTON & CO., INC.
FDA FoodClass II
Wellsley Farms Farm- Raised Atlantic Salmon Net WT. 32 oz. (2 lbs.) 907 g
Contaminated with Listeria monocytogenes
Mar 4, 2026SLADE GORTON & CO., INC.
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 24 Fr; Model No. A22041A. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Food & BeverageFDA Food
FDA FoodYO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
TENGEN USA TRADING CORP
FDA FoodClass III
YO!MAN LETTUCE (SPICY FLAVOR); Ingredients: Lettuce, chili pepper, edible vegetable oil, salt, water, sugar, food additives (monosodium glutamate, potassium sorbate, streptoccoccus lactis, sodium dehydroacetate, sodium D-isoacsorbate, disodium ethylenediaminetetraacetatic acid, sodium metabisulphite, citric acid, lactic acid, glacial acetic acid, sucralose, xanthan gum, disodium 5'flavoring ribonucleotide), food flavors and fragrances; NET WT. 4.42oz.(125g); SHELF LIFE: 9 MONTHS; PRODUCT OF CHINA; Distributed by: Tengen USA Trading Corp 262 48th Street,Brooklyn,NY 11220; UPC: 4 895235 529626
Product contains undeclared cyclamates.
Mar 4, 2026TENGEN USA TRADING CORP
PharmaceuticalFDA Drugs
FDA DrugsVista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsVista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
PharmaceuticalFDA Drugs
FDA DrugsEptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Slate Run Pharmaceuticals
FDA DrugsClass III
Eptifibatide Injection, 75 mg/100 mL vial for weight-adjusted bolus dosing, 1x100 mL Single-dose Vial, For Intravenous Use Only, Rx Only, Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Area, Haikou, Hainan Province, China 571127; Distributed by: Slate Run Pharmaceuticals, LLC, Columbus, Ohio 43215. NDC Slate Run Carton Label: 70436-027-80; NDC ProRx Carton Label: 70436-163-80
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Mar 4, 2026Slate Run Pharmaceuticals
Medical DeviceFDA Devices
FDA DevicesPIE Trolley System Model: 2005
Edermy LLC
FDA DevicesClass II
PIE Trolley System Model: 2005
Lack of 510K clearance
Mar 4, 2026Edermy LLC
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath, 28 Fr. with Deflecting Obturator. Model No. A22043T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Wizcure Pharmaa Private Limited
FDA DrugsClass II
BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesOlympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Sheath, 10 Fr. Model No. A37004A. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesOlympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath. Model No. A2641. for endoscopic diagnosis and treatment in urological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
PharmaceuticalFDA Drugs
FDA DrugsCHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Wizcure Pharmaa Private Limited
FDA DrugsClass II
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Mar 4, 2026Wizcure Pharmaa Private Limited
Medical DeviceFDA Devices
FDA DevicesMedline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline Industries, LP
FDA DevicesClass II
Medline Convenience Kits: 1) NAIL KIT, Model Number: POD14214
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Mar 4, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Inner Sheath. Model No. A4741. for endoscopic diagnosis and treatment in gynecological applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesMedline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline Industries, LP
FDA DevicesClass II
Medline Sterile Saline Wound Wash, Cleansing & Wound Irrigation, USP Normal Saline (0.9% Sodium Chloride), 7.1 FL OZ (210 mL), DBD-CAN,SPRAY,7.1-OZ,SALINE,WOUND WASH,S, Model Number MDSALINE7
Medline has identified that the manufacturer of the sterile saline wound wash may not have manufactured products to meet the minimum required sterility assurance level required for sterile products.
Mar 4, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Inner Sheath for 26 Fr. Outer Sheath. Model No. A22040T. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas
Medical DeviceFDA Devices
FDA DevicesOlympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Olympus Corporation of the Americas
FDA DevicesClass II
Olympus Resection Sheath; Model No. A2666. Resection sheath for urologic applications.
Complaints of the ceramic tip of the resection sheath breaking have been received.
Mar 4, 2026Olympus Corporation of the Americas