Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
FDA DevicesBrand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Brand Name: Spacelabs Ultraview SL Command Module Product Name: SL Command Module Model/Catalog Number: 91496 Software Version: N/A Product Description: The Command Module (91496) is the core of the Spacelabs patient monitoring system, providing the processing power for all basic physiologic parameters. The Command Module inserts into the side of a Spacelabs patient monitor. A variety of configurations can be selected to suit the monitoring needs of specific patients or care units in the hospital. Component: N/A
Due to a manufacturing issue (i.e. malfunctioning of electrical Leakage tester).
FDA FoodLoard's Maple Walnut Ice Cream - 32 oz
Loard's Maple Walnut Ice Cream - 32 oz
Undeclared Milk, Walnuts, Sulfites.
FDA DrugsBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 25x26mL Applicators per carton. Carefusion 213 LLC, El Paso, TX 79912, NDC 54365-014-42.
Lack of assurance of Sterility: potential product contamination
FDA DevicesLIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
LIFEPAK 15, REF: 99577-000025, 99577-000047, 99577-001256, 99577-001217, 99577-001241, 99577-001255, 99577-001219, 99577-001957, 99577-001935, 99577-001964, 99577-001955, 99577-001956, 99577-001588, 99577-001958, 99577-001950, 99577-001962, 99577-002178, 99577-001372, 99577-001938, 99577-000045; LIFEPAK 1000, REF: 99425-000025, 99425-000023, 99425-000096; LIFEPAK 35, REF: 99335-000013, 99335-000031; LIFEPAK 20e, REF: 99507-000122
Some defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure (PIP) was conducted, and the inability to perform the device's intended use may result in potential harms such as delays or inability to provide therapy.
FDA DrugsBD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
BD PurPrep, Povidone-iodine 8.3% w/w (0.83% available iodine) with isopropyl alcohol 72.5% w/w Sterile Solution, 0.36 fl. oz. (10.5 mL) x 25 applicators per box. Carefusion 213, LLC, El Paso, TX 79912, subsidary of Becton Dickinson and Co. NDC 54365-014-41
Lack of assurance of Sterility: potential product contamination
FDA DevicesSee RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
See RES for complete list. Medline Convenience Kits: 1) OPEN HEART CDS, Model Number:CDS840015AQ; 2) OPEN HEART CDS, Model Number:CDS840015AQ; 3) OPEN HEART CDS, Model Number:CDS840023T; 4) OFF PUMP CABG CDS, Model Number:CDS840087AI; 5) OFF PUMP CABG CDS, Model Number:CDS840087AK; 6) OFF PUMP CABG CDS, Model Number:CDS840087AL; 7) OFF PUMP CABG CDS, Model Number:CDS840087AM; 8) OPEN HEART, Model Number:CDS840150S; 9) OPEN HEART, Model Number:CDS840150T;
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesMedline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline Convenience Kits: 1) DYNDA3003, Model Number: DENTAL PACK; 2) DYNJ87157, Model Number: GULLO SURGICAL PACK
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA DevicesHalyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Halyard CARDIAC CATH TRAY SHANDS JAX kit. Model Number: SHND401-04, SHND401-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA DevicesMedline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Medline Convenience Kits: 1) LITHOTOMY PACK, Model Number: DYNJ83185; 2) LITHOTOMY PACK, Model Number: DYNJ83185A; 3) LAP BASIN, Model Number: DYNJVB91109D
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
FDA FoodChocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918
Chocolate Showers Ice Cream - 32 oz (5 labels: Mollie Stone's; Dehoff's; Farmer Joe's, Piazza's Fine Foods, and Berkeley Bowl) UPC: 8-12017-00918
Undeclared Soy (with mitigating circumstances)
FDA FoodLoard's Champagne Sherbert - 32 oz
Loard's Champagne Sherbert - 32 oz
Undeclared Milk, Red #40.
FDA FoodFain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Fain s Blackberry Honey Spread, 12oz net wt., UPC 01832213862
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA FoodLoard's Chocolate Marble Ice Cream - 32 oz
Loard's Chocolate Marble Ice Cream - 32 oz
Undeclared Milk.
FDA FoodRAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
RAW FARM RAW CHEDDAR Original NEVER WARMED ABOVE 102F (TRULY RAW) MADE WITH WHOLE RAW MILK MADE IN USA KEEP REFRIGERATED INGREDIENTS: whole raw milk, vegetable rennet, cultures, kosher sea salt Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001177 16 oz (454g) UPC: 835204000156
Multi-state outbreak of E. coli O157:H7.
FDA FoodLoard's Pistachio Ice Cream - 32 oz
Loard's Pistachio Ice Cream - 32 oz
Undeclared Milk, Pistachios, Yellow #5, Blue #1.
FDA FoodCinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC: 671333101360
Cinnamon Creamed Honey 671333101360 * These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC: 671333101360
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA FoodXZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
XZL, Jelly Snacks, 12.68 OZ, Bag. 12 Bags per Case.
Product Contains undeclared FD&C Yellow #5 & #6 and Red #40
FDA FoodRAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184
RAW FARM RAW CHEDDAR SIMPLY SHREDDED Original MADE WITH: WHOLE RAW MILK TRULY RAW - NEVER WARMED ABOVE 102F MADE IN THE USA KEEP REFRIGERATED INGREDIENTS: WHOLE RAW MILK, VEGETABLE RENNET, CULTURES, KOSHER SEA SALT Produced By: RAW FARM, LLC www.rawfarmusa.com 8 oz (227g) UPC: 835204001184
Multi-state outbreak of E. coli O157:H7.
FDA FoodLemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101353
Lemon Creamed Honey, 671333101353 *These product labels may also say Whipped Honey instead of Creamed Honey as labels and size were changed in this timeline from 14 oz Creamed Honey to 11 oz Whipped Honey. The UPC codes remained the same. Packaged in Glass jars UPC Code: 671333101353
Creamed honey products may contain stainless steel dust/flakes and/or small particles or shreds of plastic.
FDA DevicesHalyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Halyard HEART CATH, SELF REGIONAL kit. Model Number: SELF131-05.
Potential risk for Medline syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.
FDA FoodLoard's Peanut Butter Fudge Ice Cream - 32 oz
Loard's Peanut Butter Fudge Ice Cream - 32 oz
Undeclared Milk, Peanuts.
FDA FoodLoard's Banana Ice Cream - 32 oz; 56 oz
Loard's Banana Ice Cream - 32 oz; 56 oz
Undeclared Milk, Yellow #5.
FDA FoodLoard's Orange Sherbert - 32 oz
Loard's Orange Sherbert - 32 oz
Undeclared Milk, Yellow #5.
FDA FoodLoard's Pumpkin Ice Cream - 32 oz
Loard's Pumpkin Ice Cream - 32 oz
Undeclared Milk, Yellow #6.