Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.
Favorina Chocolate Ladybugs German-Style Nougat, Net Wt 3.52 oz (100g). UPC 2030 4492. Distributed By Lidl US, LLC, 3500 S. Clark St, Arlington, VA 22202. Product of Germany.
Label does not specify type of tree nut contained in the product.
Pepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Pepsin Full Strength Powder, 50 kg, Item #5000545, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Potential Salmonella contamination.
Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.
Slow Roasted Diced Tomatoes (SKU 900, UPC 00823338009008). Frozen. Shelf life: 365 days (frozen) from date of manufacture; 30 days (refrigerated, unopened); 7 days (refrigerated, opened). Plastic poly liner inside cardboard box (bulk). Net weight: 24 lbs. Firm: Sevillo Fine Foods, Salt Lake City UT, 84115.
Product may contain foreign material (metal fragments).
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1. Anterolateral Tibia Plate; Article Numbers: 21311-11, 21311-15, 21311-7, 21312-11, 21312-15, 21312-7. 2. Pilon Plate 4mm; Article Numbers: 21094-10, 21094-4, 21094-6, 21094-8. 3. Pilon Plate, Small; Article Numbers: 21093-4, 21093-6.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) REF: 20402-401 STERILE EO. For surgical use
Probes may rupture/burst during activation
Basil Pesto & Mozzarella Pizza NET WT. 13.90OZ (394g) UPC 8 57919 00785 5 Distributed by: Grocery Delivery E-Services New York, NY 10005
Basil Pesto & Mozzarella Pizza NET WT. 13.90OZ (394g) UPC 8 57919 00785 5 Distributed by: Grocery Delivery E-Services New York, NY 10005
Metal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by one of their ingredient suppliers.
Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN
Pan de Bono (Cheese Bread), 100 units per Paper Cardboard Box, Net Wt 14.4 lb. KEEP FROZEN
Undeclared Soy.
Pepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Pepsin 1:10,000 Powder, 10 kg, Item #FTI-G0193-00, American Laboratories 5036 South 33rd Street, Omaha, Nebraska 68107. Packed in double poly-lined cardboard drums or boxes.
Potential Salmonella contamination.
Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in an umami dashi sauce Net wt. 17oz. Retail box UPC 071757508934. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/17oz. boxes or 8.5 lbs. per case. Case UPC 10071757508931. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 5650893 Ajinomoto Japanese-Style Vegetable Fried Rice made with hijiki seaweed, fried tofu, edamame, and other colorful vegetables in an umami dashi sauce Net wt. 17oz. Retail box UPC 071757508934. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 8/17oz. boxes or 8.5 lbs. per case. Case UPC 10071757508931. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
CentrosFLO Hemodialysis Catheters, REF: CENFP15K/A, CENFP15K/B, CENFP17K/A, CENFP19K/A, CENFP23K/A, CENFP27K/A, CENFP31K/A, CENFT15K, CENFT15K/D, CENFT17K, CENFT17K/A, CENFT17K/D, CENFT19K, CENFT19K/A, CENFT19K/B, CENFT19K/D, CENFT23K, CENFT23K/A, CENFT23K/B, CENFT23K/D, CENFT27K, CENFT27K/A, CENFT27K/B, CENFT27K/D, CENFT31K, CENFT31K/A, CENFT31K/B, CENFT31K/D
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
MiniMed" 780G - MMT-1884 MiniMed" 780G - MMT-1886 With Software 6.60 and 6.61
Three software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions 6.60, 6.61, and 6.62), which could result in a risk of hypoglycemia or hyperglycemia due to inaccuracies in insulin delivery (either under-delivery, over-delivery, or cessation of delivery).
Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 6430143 Ajinomoto Vegetable Gyoza Dumplings 12ct. Net wt. 8.92oz. per package. Retail package UPC: 071757055483. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 20/8.92oz. packages or 11.15 lbs. per case. Carton UPC 10071757055480. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
SiluetaYa Mexican Tejocote Roots Supplement Pieces; 7g/bottle; Dietary Supplement, UPC#: 7500464462411, Lot: US1220 " Expiration Date: 06/2027
SiluetaYa Mexican Tejocote Roots Supplement Pieces; 7g/bottle; Dietary Supplement, UPC#: 7500464462411, Lot: US1220 " Expiration Date: 06/2027
Product contains yellow oleander
Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.
Item 81146 Ajinomoto Tai Pei Shrimp Fried Rice - Shrimp, vegetables & fried rice with oyster flavored sauce. Net wt. 48oz or 3lbs. per box. Retail box UPC 070077811465. Product packaging is flexible bags in a master case or flexible bags in cartons in a master case. There are 4/48oz. boxes or 12lbs. per case. Case UPC 10070077811462. All products are intended to be stored frozen and fully cooked to 165F before eating.
Foreign objects are glass varying in size from 1-3cm long and 2-4mm wide.
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 33342-401-44
Subpotent Drug
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Failed tablet specifications.
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Gelatin Capsule Pack for use with the Sodium Iodide I-131 Kit (containing 5 empty capsules and 5 Dibasic Sodium Phosphate Capsules 300 mg, International Isotopes Inc., Idaho Falls, ID 83401. NDC: 69208-003-15; 69208-003-25; 69208-003-35
Failed Tablet/Capsule Specifications
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and corresponding article numbers. 1. FLS - Foot Locking Plates System, Cancellous Stabilization Screw; Article Numbers: 37303-10, 37303-12, 37303-14, 37303-16, 37303-18, 37303-20, 37303-22, 37303-24, 37303-26, 37303-28, 37303-30. 2. FLS - Foot Locking Plates System, Cortical Screw; Article Numbers: 32271-10, 32271-12, 32271-14, 32271-16, 32271-18, 32271-20, 32271-22, 32271-24, 32271-26, 32271-28, 32271-32, 32271-34. 3. FLS - Foot Locking Plates System, Cortical Stabilization Screw; Article Numbers: 37304-10, 37304-12, 37304-14, 37304-16, 37304-18, 37304-20, 37304-22, 37304-24. 4. FLS - Foot Locking Plates System, FLS Plate, Curved; Article Numbers: 21413-6. 5. FLS - Foot Locking Plates System, FLS Plate, H-Shape; Article Numbers: 21431-ME. 6. FLS - Foot Locking Plates System, FLS Plate, L-Shape; Article Numbers: 21482, 21483. 7. FLS - Foot Locking Plates System, FLS Plate, Straight; Article Numbers: 21421-5. 8. FLS - Foot Locking Plates System, Stabilization Screw; Article Numbers: 37241-10, 37241-12, 37241-14, 37241-16, 37241-18, 37241-20, 37241-22, 37241-24, 37241-26, 37241-28, 37241-30. 9. HOL - Hallux Osteotomy Locking Plate, Hallux Osteotomy Plate; Article Numbers: 21015-08, 21015-09.
Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for Use (IFU).
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Philips Respironics Trilogy Evo Universal, Software Version 1.05.15.00. Continuous home-use ventilator device.
Using non-pneumatic nebulizers with Trilogy Evo Platform ventilators may result in a discrepancy between the set tidal volume and the tidal volume received by the patient.
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
ProGuide Chronic Dialysis Catheters, REF: DC01455550/C, DC21452419/C, DC21452419-NE5/C, DC21452823-NE5/C, DC21454035/C, DC21455550/C
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.
Ford Motor Company - Incorrectly Installed Piston Circlips
Ford Motor Company - Incorrectly Installed Piston Circlips
An unexpected loss of drive power increases the risk of a crash.
Ford Motor Company - Inoperative Defrosting and Defogging System
Ford Motor Company - Inoperative Defrosting and Defogging System
An inoperative windshield defrosting and defogging system may decrease the driver's visibility, increasing the risk of a crash.
Ford Motor Company - Front Passenger Air Bag May Not Deploy/FMVSS 208
Ford Motor Company - Front Passenger Air Bag May Not Deploy/FMVSS 208
Failure to correctly detect a passenger may result in the air bag not deploying as intended, increasing the risk of injury during a crash.