Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A
Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for Portable Fuel Containers; Imported by Mameix Retail

Scepter Fuel Containers Recalled Due to Risk of Serious Injury or Death from Flash Fire, Burn and Child Poisoning; Violates Mandatory Standards for Portable Fuel Containers; Imported by Mameix Retail
The recalled fuel containers violate the mandatory safety standards for portable fuel containers because they lack flame mitigation devices required under the Portable Fuel Container Safety Act, posing a deadly risk of flash fire. In addition, the Children's Gasoline Burn Prevention Act requires all closures on portable gasoline fuel containers to be child resistant. The spout on the product is not child-resistant, posing a risk of burn and poisoning to children.
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: no
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
Upgrade to MR 7700. Product Code (REF): 782130. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
PREGNANCY TEST 24CT
PREGNANCY TEST 24CT
Potential exposure of rodents and rodent activity in the distribution center.
Genesis Dual Thread Screw-In Anchor
Genesis Dual Thread Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Butternut Squash Tamales With Roasted Green Chiles, Corn & Jack Cheese Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, Organic Roasted Green Chiles, Non-GMO Corn, Organic Jalapeno Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Organic Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000232
Butternut Squash Tamales With Roasted Green Chiles, Corn & Jack Cheese Ingredients: Organic Corn Flour Masa, Organic Butternut Squash, Organic Roasted Green Chiles, Non-GMO Corn, Organic Jalapeno Jack Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Organic Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000232
Potential contamination with biological hazards (Listeria monocytogenes).
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23
Incorrect expiration date
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weight-based reference tool specifically designed for pediatric emergency care. Component: No
Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Mushroom, Spinach & Salsa Tamales No Dairy Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Tomatoes, Onions, Jalapenos, Non-hydrogenated Vegetable Shortning, Salt, Spices, Baking Powder. Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000317
Mushroom, Spinach & Salsa Tamales No Dairy Ingredients: Organic Corn Flour Masa, Mushrooms, Spinach, Tomatoes, Onions, Jalapenos, Non-hydrogenated Vegetable Shortning, Salt, Spices, Baking Powder. Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000317
Potential contamination with biological hazards (Listeria monocytogenes).
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Medline medical procedure convenience kits labeled as: 1) PACER / CATH LAB PACK-LF, Kit SKU DYNJ0972604A; 2) PACEMAKER/ICD PACK, Kit SKU DYNJ33822L; 3) VENOUS ACCESS PACK, Kit SKU DYNJ45640B; 4) PACEMAKER SET UP, Kit SKU DYNJ63377D; 5) PACK PACEMAKER CUSTOM,9909178, Kit SKU DYNJ65011D; 6) HEART BASIC OPEN PACK, Kit SKU DYNJ69143C; 7) SCC VEIN PACK, Kit SKU DYNJ69313; 8) CV PACK, Kit SKU DYNJ86007B.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Genesis Screw-In Anchor
Genesis Screw-In Anchor
Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 8.5OZ (240G); Manufactured for Superfoods, Inc.; UPC: 860013190804 b.) Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30-0.28oz (8g) STICKS - NET WT. 8.47oz (240g); Manufactured for Superfoods, Inc.; UPC: 850077468063
Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30 day supply; NET WT. 8.5OZ (240G); Manufactured for Superfoods, Inc.; UPC: 860013190804 b.) Live it Up brand Super Greens; Chlorella, Spirulina, Wheatgrass, Kale, Broccoli, Spinach, Barley grass, Moringa, Parsley; Whole food dietary supplement powder; 30-0.28oz (8g) STICKS - NET WT. 8.47oz (240g); Manufactured for Superfoods, Inc.; UPC: 850077468063
Products may be contaminated with Salmonella Typhimurium
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medline medical procedure convenience kits labeled as: NERVE BLOCK TRAY 2, Kit SKU DYNJRA2713
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
HIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM, LEMON JUICE CONCENTRATE, LIVE AND ACTIVE CULTURES, VITAMIN B12; CONTAINS: COCONUT
HIGHER HARVEST by H-E-B brand; Dairy Free Coconut Based YOGURT; STRAWBERRY; YOGURT ALTERNATIVE; NET WT 5.3 OZ; INGREDIENTS: COCONUT MILK (WATER, COCONUT CREAM, MODIFIED TAPIOCA STARCH), STRAWBERRIES, CANE SUGAR, WATER, STARCH, NATURAL FLAVOR, FRUITS AND VEGETABLE JUICE (FOR COLOR) LOCUST BEAN GUM, LEMON JUICE CONCENTRATE, LIVE AND ACTIVE CULTURES, VITAMIN B12; CONTAINS: COCONUT
Contains undeclared Almonds
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Roasted Pumpkin & White Cheddar Tamales Ingredients: Organic Corn Flour Masa, Pumpkin, Green Chile, Sharp Cheddar Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Contains Milk Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000263
Roasted Pumpkin & White Cheddar Tamales Ingredients: Organic Corn Flour Masa, Pumpkin, Green Chile, Sharp Cheddar Cheese (Pasteurized Milk, Cheese Cultures, Salt and Enzymes), Butter, Salt, Spices, Baking Powder (Sodium Acid Pyrophosphate, Sodium Bicarbonate, Corn Starch and Monocalcium Phosphate). Contains Milk Microwave: In husk approx. 90 seconds per tamale. Steam: In husk approx. 15 minutes. Primavera 17070 Sonoma Hwy. Sonoma, CA 95476 (707) 939-9350 Perishable Keep Refrigerated Net Wt. 24oz. UPC: 748732000263
Potential contamination with biological hazards (Listeria monocytogenes).
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
Medline medical procedure convenience kits labeled as: 1) MIDDLE EAR CDS, Kit SKU CDS984347O; 2) HEAD AND NECK CDS-LF, Kit SKU CDS984857N; 3) NECK PACK-LF, Kit SKU DYNJ0966130K; 4) NECKLINE PACK-LF, Kit SKU DYNJ51440B; 5) THYROID PACK, Kit SKU DYNJ58742J; 6) ENT I, Kit SKU DYNJ63781B; 7) NECK PACK, Kit SKU DYNJ82751B; 8) NOSE PACK, Kit SKU DYNJ82753C; 9) WMC COCHLEAR IMPLANT ADD ON, Kit SKU DYNJ907206G.
Medline kits were manufactured and distributed containing MASTISOL liquid adhesive which was recalled due to complaints that the butyrate tubing cracked during actuation of the vials of MASTISOL Liquid Adhesive.
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
Bandages and first aid kits: FIRST AID KIT 24/42PC, LUCKY FIRST AID BANDAGES 24CT
Potential exposure of rodents and rodent activity in the distribution center.
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
Conductivity Standard Solution Catalog/Model Numbers: 10001, 10011, 10021, 10032, 10040, 10040c, and 10041 Conductivity Standard Solutions are a secondary standard solution used for the calibration of conductivity cells together with conductivity meters
due to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect conductivity values for dialysate.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.
The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.