Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesBrand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Brand Name: Aptima HPV Assay Product Name: Aptima HPV Assay Model/Catalog Number: 303585 Product Description: Aptima HPV assay Component: No
Due to product exhibiting potential to generate either invalid or false negative results.
FDA DevicesCentricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-026, 2088026-115, 2088026-043, K2042VJED, 2088026-132, 2088026-003, 2088026-110, 2089629-003, 2066908-136, 2066908-150
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
NHTSAVolkswagen Group of America, Inc. - Instrument Panel Failure/FMVSS 101
Volkswagen Group of America, Inc. - Instrument Panel Failure/FMVSS 101
An instrument panel that does not display critical safety information, such as the speedometer or warning lights, can increase the risk of a crash.
NHTSAAston Martin The Americas - TPMS May Not Illuminate for Low Pressure/FMVSS 138
Aston Martin The Americas - TPMS May Not Illuminate for Low Pressure/FMVSS 138
Underinflated tires increase the risk of a crash.
FDA DevicesConvatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Convatec, EsteemBody Drainable Pouch REF:423653 10-35mm
Drainable large pouch may leak due to manufacturing issue.
FDA DevicesConvatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Convatec, EsteemBody Drainable Pouch REF:423643, 10-45mm
Drainable large pouch may leak due to manufacturing issue.
FDA DevicesArtegraft Vascular Graft; REF#: AG740;
Artegraft Vascular Graft; REF#: AG740;
Labeling mix-up resulting in the incorrect lot outer packaging of product.
FDA FoodGreat Value Cottage Cheese Small Curd 4% Milkfat NET WT 16oZ UPC 0 78742 37235 8; 24oz UPC 0 78742 37236 5 & 3lb UPC 0 78742 14797 0 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Great Value Cottage Cheese Small Curd 4% Milkfat NET WT 16oZ UPC 0 78742 37235 8; 24oz UPC 0 78742 37236 5 & 3lb UPC 0 78742 14797 0 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
FDA DevicesCentricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including mammograms) and data from various imaging sources, Model Numbers 2088026-406, 2100169-001, 2088026-985, 2088026-971, 2088026-614, 2088026-713, 2088026-994, 2100491-006, 2088026-723, 2088026-308, 2104867-044, 2100491-012, 2088026-962, 2088026-969, 2102676-001, 2088026-936, 2088026-960, K1220JWED, 2088026-806, 2088026-506, 2088026-026, 2088026-970, 2088026-943, 2088026-990, 2088026-940, 2088026-959, 2088026-967, 2088026-989, 2104867-045, 2088026-993, 2088026-306, 2102675-010, 2088026-948, 2088026-957, 2088026-973, 2088026-946, 2088026-715, 2088026-906
There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, which could allow an unauthorized individual to potentially impact system availability and/or manipulate data.
FDA DevicesBrand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife¿ Perfexion Leksell Gamma Knife¿ Icon" Leksell Gamma Knife¿ Elekta Esprit Leksell Gamma Knife¿ (available models Elekta Esprit, Icon", and Perfexion") is a radiosurgery system for use in the stereotactic irradiation of head structures. Surgery is achieved by delivering a prescribed dose as one or more shots of ionizing radiation to the exact site of the target.
Due to adapter not being properly aligned or locked in place.
FDA FoodWawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated
Wawa Double Dutch Chocolate Milk ,16 oz (Pint) Plastic bottle Store Refrigerated
Foreign plastic material discovered on fill line.
FDA FoodMultivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS UPC 3 15826 16910 2; NDC 75826-171-10 1mg 100 TABLETS UPC 3 15826 17110 5 Manufactured by: WINDER LABORATORIES LLC Winder, GA 30680
Subpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D.
FDA FoodTETAS Mireya, Cherry Milkshake (Colita con Leche), i unit Popsicle, Net wt 6OZ. 170GRS. KEEP FROZEN. UPC Code 83822654822
TETAS Mireya, Cherry Milkshake (Colita con Leche), i unit Popsicle, Net wt 6OZ. 170GRS. KEEP FROZEN. UPC Code 83822654822
Undeclared allergen: Soy Lecithin
FDA FoodMID EAST Jordanian Zaatar spice mix; NET Wt. 5lb plastic bag; UPC: 094379607038 Packed by: Propack Inc. Sunvalley, CA 91354
MID EAST Jordanian Zaatar spice mix; NET Wt. 5lb plastic bag; UPC: 094379607038 Packed by: Propack Inc. Sunvalley, CA 91354
Undeclared allergen ingredients (sesame and wheat) in Zaatar Spice mix.
FDA FoodButter-Rich Powder, Net Weight 50 LB., packaged in a multiply Kraft bag with poly liner
Butter-Rich Powder, Net Weight 50 LB., packaged in a multiply Kraft bag with poly liner
Potential Salmonella contamination
FDA DrugsWebcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Webcol Alcohol Prep pad (70% isopropyl alcohol) 2 ply, 200 count boxes, Cardinal Health 200 LLC 3651 Birchwood Drive, Waukegan, IL 60085.
Non-Sterility: microbial contamination identified as Paenibacillus phoenicis
FDA FoodSimply Nature, Spinach Bites, 12 oz retail unit, Plastic wrapped bites inside of a retail box. Keep Frozen.
Simply Nature, Spinach Bites, 12 oz retail unit, Plastic wrapped bites inside of a retail box. Keep Frozen.
This product has the possibility of contamination with rodent hair.
FDA DrugsPitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Pitavastatin Tablets, 2 mg, packaged in 90-count bottles, Rx only, Manufactured for: Northstar Rx LLC, Memphis, TN 38141, Manufactured by: Annora Pharma Pvt. LTd., Sengareddy - 502313, Telengana, India, NDC 72603-479-01.
Presence of foreign tablets/capsules: one Pitavastatin tablet 1mg found in bottle of Pitavastatin tablets 2mg
FDA FoodCLOVER SONOMA SOUR CREAM NET WT 8OZ UPC 0 70852 61800 5 & 16OZ UPC 0 70852 61500 4 DISTRIBUTED BY: CLOVER-STORNETTA FARMS LLC PETALUMA, CA 94952
CLOVER SONOMA SOUR CREAM NET WT 8OZ UPC 0 70852 61800 5 & 16OZ UPC 0 70852 61500 4 DISTRIBUTED BY: CLOVER-STORNETTA FARMS LLC PETALUMA, CA 94952
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
FDA FoodGreat Value Fat Free Cottage Cheese Small Curd 0% Milkfat NET WT 24OZ UPC 0 78742 37339 3 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Great Value Fat Free Cottage Cheese Small Curd 0% Milkfat NET WT 24OZ UPC 0 78742 37339 3 DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716
Potentially under pasteurized. The firm was notified by the California Department of Agriculture that due to the broken seal on the pasteurizer, the products may be under pasteurized, and they should recall the products.
FDA FoodDreamland's Zaatar Chickpea Salad is packaged in poly bags with a generic label which declares "chickpeas, cumin, zataar, turmeric, dill, onion, garlic, parsley". Dreamland distributed bulk cases (2/5lbs. bags per case) to Haggen store. Bulk 5lbs. bags were not sold directly to consumers. Haggen stores unpacked 5lb. bags of chickpea salad into cold food pan at salad bar (without mixing with other ingredients), consumers packed product in grab & go containers, and Haggen applied scale label when members paid at the register.
Dreamland's Zaatar Chickpea Salad is packaged in poly bags with a generic label which declares "chickpeas, cumin, zataar, turmeric, dill, onion, garlic, parsley". Dreamland distributed bulk cases (2/5lbs. bags per case) to Haggen store. Bulk 5lbs. bags were not sold directly to consumers. Haggen stores unpacked 5lb. bags of chickpea salad into cold food pan at salad bar (without mixing with other ingredients), consumers packed product in grab & go containers, and Haggen applied scale label when members paid at the register.
Undeclared Sesame, Soy, Wheat
FDA DrugsDexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Dexamethasone Sodium Phosphate Injection, USP, 100 mg/ 10 mL, (10 mg/mL), 10x10 mL Multiple Dose Vials, Rx only, Manufactured for: Somerset Therapeutics, LLC., Somerset, NJ 08873, NDC carton: 70069-025-10; NDC vial: 70069-025-01
Failed Impurities/Degradation Specifications - OOS impurities result observed during long term stability testing at product expiry (24 months) were above specs for these impurities: Dexamethasone Sodium Phosphate EP impurity G (Impurity RU 49336) and dexamethasone formate.
FDA DevicesConvatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Convatec, EsteemBody Drainable Pouch REF:423657 10-35mm
Drainable large pouch may leak due to manufacturing issue.
FDA DevicesCub Pediatric Crib, Model FL19H
Cub Pediatric Crib, Model FL19H
Cribs sold in the USA are missing two access door warning labels.