Vereinigte Staaten Recalls
Verbraucherrückrufe von FDA, CPSC, NHTSA und USDA FSIS.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Devices are not suitable for organ transplant.
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.
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.
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.
Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027
Sam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027
Potential contamination with Salmonella.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)
EverRoast Chicken Caesar Wrap 85004224455 Net Wt: 11.25 oz (303g)
Potential presence of 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
Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064 100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035 100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073
Snack Crackers 100to en boca (ciento en boca) Rovira, Net Wt. 1.5 oz, 12 pack Snack Crackers to go, 12 packets (Net Wt 1.5 oz bag) per box, 12/ 1.5 oz packets box, 6 box per case. UPC 072981023064 100to en boca (ciento en boca), Rovira, Net Wt. 7 oz, 7 pack Snack Crackers to go, 7 packets (Net Wt 1 oz bag) per box, 18/7oz box per case. UPC 072981003035 100to en boca (ciento en boca) Rovira, tray, Net Wt. 18 oz, 6 packets (Net Wt 1.5 oz tray) per box per case. UPC 072981003073
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
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.
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
ReBoost Nasal Spray, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4005-9, UPC 787647101863
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
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
Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Spicy Egg Potatoes Cheese Tacos, Fresh to You brand, Ready to Eat, Refrigerated. Net wt. 6.3oz. UPC 100000010389, LPK110369V06. Fresh & Ready Foods, 701 Monster Rd, Renton, WA 98057.
Foreign material.
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.
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Tri-Moxi+¿ (Triamcinolone 9mg/0.6mL, Moxifloxacin 0.6 mg/ 0.6 mL) Single-Use Intraocular Injection, Imprimis NJOF, LLC., 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852. NDC 71384-746-06.
Presence of particulate matter - Glass like particles.
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not Applicable Product Description: The HFD100 Head Fixation Device provides rigid skeletal fixation within the optimal imaging envelope while introducing minimal artifacts in the acquired images. There are two different assemblies for the HFD100. The standard HFD100 is equipped with a table adapter for use with either the operating room table or the angiography table. For sites with a Hill-Rom TruSystem 7500 Hybrid Neuro MR Operating Table (ORT400), the HFD100 has a split block clamp assembly (Trumpf Mount Clamp Assembly) which connects directly to the table back section. The HFD100 system is also comprised of the linkage components to mount the skull clamp to the table adapter, and the 3-pin skull clamp. The linkage system is used to position the skull clamp in the necessary position, without colliding with the magnet bore. Component: Not a component.
Torque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
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.
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
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
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