Estados Unidos Recalls
Retiros de seguridad del consumidor de la FDA, CPSC, NHTSA y USDA FSIS.
Spicy Breakfast Burrito, Sprig & Sprout brand, Ready to Eat. Refrigerated. Net wt. 9.1oz. UPC 100001000297, SS00297v02. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Spicy Breakfast Burrito, Sprig & Sprout brand, Ready to Eat. Refrigerated. Net wt. 9.1oz. UPC 100001000297, SS00297v02. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374
Vanilla Treats Crackers, Rovira, Net Wt. 31 oz (878.83 g) cans, 6/31oz cans per case. Mini Vanilla Treats, Rovira, 12 to go packs (0.8oz (22.7g) each), Net Wt 9.6 oz (272g), 6/9.6oz boxes per case. UPC072981005374
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Meijer Steam Distilled Water, 128 FL OZ (1 GAL) 3.78L, packaged in a plastic jug with red plastic lid, UPC 041250841197, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, packed 4 per case
Meijer Steam Distilled Water, 128 FL OZ (1 GAL) 3.78L, packaged in a plastic jug with red plastic lid, UPC 041250841197, Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544, packed 4 per case
Floating black foreign substance in the product
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580
Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT, 1.5QT, 2 QT, and 3QT sizes; UPC Codes: 843784003559, 843784003566, 843784003573, 843784003580
Product found to contain leachable lead levels.
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022
Vainilla Crackers, Great Value (Galletas Vainilla)8 Foil Packets (17 g each), Net Wt.9.6 oz (272 g) box, 6 boxes per case. UPC 072981005022
Undeclared colors FD&C Yellow #6, and FD&C Red 40
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Product tested positive for Listeria Monocytogenes.
Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per case. UPC 1 07 34730 62740 0. Distributed by Sysco Corporation, Houston, TX. Product of U.S.A.
Sysco Imperial Potato Tater Barrel, item number 1000006067. Frozen potato product is packaged in 6/5 lb. clear unlabeled poly bags per case. UPC 1 07 34730 62740 0. Distributed by Sysco Corporation, Houston, TX. Product of U.S.A.
Clear hard plastic fragments.
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Dexamethasone Moxifloxacin, 1 mg/mL and 5 mg/mL, 1 mL Intraocular Injection, Rx only, Imprimis NJOF, LLC, Ledgewood, NJ 07852, NDC 71384-512-0.1
Presence of particulate matter - Glass like particles.
Spicy Veggie Breakfast Burrito, Fresh to You, Ready to Eat, Refrigerated. Net wt. 9.1oz. UPC 100000010310, LPK110310V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057
Spicy Veggie Breakfast Burrito, Fresh to You, Ready to Eat, Refrigerated. Net wt. 9.1oz. UPC 100000010310, LPK110310V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057
Foreign material.
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)
Potential presence of Listeria monocytogenes.
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg, 100 tablets, Rx only, SpecGx LLC, Webster Groves, MO 63119, NDC 0406-0522-01. Case label: SpecGx LLC, NDC 0406052201, Exp. 2027/03, Lot: 0522J23493
Failed Tablet/Capsule Specification: There is a potential for the imprint to be missing on tablets.
Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343 Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case.
Tita Crackers Rovira, 3 (1/2 oz (15g) Foil Fresh Packets Net Wt.8 oz (226.8 g) boxes, 6/8oz boxes per case. UPC 072981005121 Tita Crackers Rovira, Net Wt. 24 oz (680 g) boxes, 6/24 oz boxes per case. UPC 072981005343 Tita Crackers Rovira, Net Wt 24 oz (680 g) cans, 6/24 oz boxes per case.
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.
Ore-Ida Tater Tots shaped potatoes, item number OIF00215A. Frozen potato product is packaged in clear unlabeled poly bag per case. Net wt. 30 lbs. UPC 1 00 72714 00215 8. McCain Foodservice Solutions.
Clear hard plastic fragments.
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
The AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT is informing customers of an omission identified in the Instructions for Use for AlignRT InBore systems. Information identifying the lasers and their characteristics was omitted from the Instructions for Use for the subject system as required by 21 CFR 1040,10(h), via conformance with recognized consensus standard IEC 60825-1 Ed. 3 (FDA Laser Notice 56).
Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
Vanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
Product tested positive for Listeria Monocytogenes.
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
May contain partially hydrogenated oils
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Codman Microsensor Basic Kit. Catalog Number: 626631US. Use of the CODMAN MICROSENSOR Basic Kit is indicated when direct ICP monitoring is required. The kit is indicated for use in both subdural and intraparenchymal pressure monitoring applications only.
Potential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits.