États-Unis Recalls
Rappels de sécurité de la FDA, CPSC, NHTSA et de l’USDA FSIS.
Showing 24 of 17,563 results
Medical Device
FDA Devices
FDA DevicesThe Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Sophysa
FDA DevicesClass II
The Pressio 2 ICP Monitoring System, Model Number PSO-4000; Intracranial Pressure Monitor
Customer complaints of Pressio monitor rebooting.
Jan 14, 2026Sophysa
PharmaceuticalFDA Drugs
FDA DrugsORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
Signature Formulations, LLC
FDA DrugsClass II
ORL Kids Mouthwash, Bubblegum Flavor, 16.9 oz. (500ml) per bottle, ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Jan 14, 2026Signature Formulations, LLC
Food & BeverageFDA Food
FDA Foodwaterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is 0 21130 13224 9. Product of Indonesia. DISTRIBUTED BY LUCERNE FOODS, INC. P.O. BOX 99 PLEASANTON, CA 94566.
DIRECT SOURCE SEAFOOD LLC
FDA FoodClass II
waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is 0 21130 13224 9. Product of Indonesia. DISTRIBUTED BY LUCERNE FOODS, INC. P.O. BOX 99 PLEASANTON, CA 94566.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Jan 14, 2026DIRECT SOURCE SEAFOOD LLC
Food & BeverageFDA Food
FDA FoodVanilla 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
Rovira Biscuit Corporation
FDA FoodClass II
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
Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageFDA Food
FDA FoodVainilla 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
Rovira Biscuit Corporation
FDA FoodClass II
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
Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageFDA Food
FDA FoodTita 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.
Rovira Biscuit Corporation
FDA FoodClass II
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
Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageFDA Food
FDA FoodMeijer 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 Inc
FDA FoodClass II
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
Jan 14, 2026Meijer Inc
Food & BeverageFDA Food
FDA FoodOre-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.
McCain Foods USA Inc
FDA FoodClass II
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.
Jan 14, 2026McCain Foods USA Inc
Food & BeverageFDA Food
FDA FoodSnack 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
Rovira Biscuit Corporation
FDA FoodClass II
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
Jan 14, 2026Rovira Biscuit Corporation
Medical DeviceFDA Devices
FDA DevicesCodman 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.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
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.
Jan 14, 2026Integra LifeSciences Corp. (NeuroSciences)
Food & BeverageFDA Food
FDA FoodLocatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Ambriola Co., Inc., The
FDA FoodClass I
Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Food & BeverageFDA Food
FDA FoodSam Dry Fruits & Nuts PISTACHIO Meats Whole LOT #: PK00459 NET WEIGHT: 30 LBS PACK DATE: AUGUST/2025 EXPIRATION DATE: AUGUST/2027
Sam Dry Fruits and Nuts Enterprises, Inc
FDA FoodClass I
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.
Jan 14, 2026Sam Dry Fruits and Nuts Enterprises, Inc
Food & BeverageFDA Food
FDA FoodVanilla Econo, Galletas de Vainilla, 8 paquets per Net Wt. 9.6 oz box (272 g), 6 box per case. UPC 072981005022
Rovira Biscuit Corporation
FDA FoodClass II
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
Jan 14, 2026Rovira Biscuit Corporation
Food & BeverageFDA Food
FDA FoodTempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127 Tempting Crackers, Rovira, 12 packets (Net Wt. 1.0 oz (30 g) bag) per box, 12/ 1.0 oz packets box, 6/ 12-1oz box per case. UPC 072981003127
Rovira Biscuit Corporation
FDA FoodClass II
Tempting Crackers Tray, Rovira, 3 foil wrap trays per Net Wt. 8oz box (Net Wt 5 oz trays), 6 box per case. UPC 072981003127 Tempting Crackers, Rovira, 12 packets (Net Wt. 1.0 oz (30 g) bag) per box, 12/ 1.0 oz packets box, 6/ 12-1oz box per case. UPC 072981003127
Undeclared colors FD&C Yellow #6, and FD&C Red 40
Jan 14, 2026Rovira Biscuit Corporation
Medical DeviceFDA Devices
FDA DevicesRevogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
Meridian Bioscience Inc
FDA DevicesClass II
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300
The affected lots show a decline in performance over time, which may lead to false-negative results.
Jan 14, 2026Meridian Bioscience Inc
Medical DeviceFDA Devices
FDA DevicesCodman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor 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.
Integra LifeSciences Corp. (NeuroSciences)
FDA DevicesClass II
Codman CereLink ICP Sensor Basic Kit. Catalog Number: 826850. The Codman CereLink ICP Sensor Basic Kit consists of the CereLink ICP Sensor (ICP Sensor) and a 14-gauge Tuohy needle with stylet. The ICP Sensor is a nylon tube with a microminiature strain gauge pressure transducer (sensing element) mounted at one end and an electrical connector at the other end. It is designed for use with a Codman intracranial pressure monitoring device. The ICP Sensor Basic Kit is designed for use with the Codman Cranial Hand Drill. The drill facilitates access to the intraparenchymal area. The drill is also available as a component of the Codman Cranial Access Kit. Use of the ICP Sensor 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.
Jan 14, 2026Integra LifeSciences Corp. (NeuroSciences)
Medical DeviceFDA Devices
FDA DevicesBeckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA DevicesClass II
Beckman Coulter UniCel Dxl 600, Part numbers: A71460, A71461, A30260; Immunoassay Method, Troponin Subunit
Beckman Coulter has determined that, due to a potential communication issue, the analyzers listed above may not successfully restart following a standard shutdown, even after multiple attempts. If this issue occurs, the instrument will be unable to complete initialization and transition to Ready mode and the instrument will not process patient samples, QCs or calibrators. This causes delayed results.
Jan 14, 2026Beckman Coulter, Inc.
Medical DeviceFDA Devices
FDA DevicesThe AlignRT InBore system contains six Class 1 lasers which enables the system s cameras to track the patient s position and movement.
Vision RT Ltd
FDA DevicesClass II
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).
Jan 14, 2026Vision RT Ltd
Food & BeverageFDA Food
FDA FoodLocatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
Ambriola Co., Inc., The
FDA FoodClass I
Locatelli Grated Pecorino Romano 48/8oz Shipper, Plastic Cup & Lid, 48 units per case
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceFDA Devices
FDA DevicesArial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3
Securitas Healthcare LLC
FDA DevicesClass II
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.
Jan 14, 2026Securitas Healthcare LLC
Food & BeverageFDA Food
FDA FoodBaraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
ZIYAD BROTHERS IMPORTING
FDA FoodClass II
Baraka Gourmet Pastry Kunafe 6.7oz., UPC 822514291060, 18 retail units per wholesale case
May contain partially hydrogenated oils
Jan 14, 2026ZIYAD BROTHERS IMPORTING
Food & BeverageFDA Food
FDA FoodLocatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Ambriola Co., Inc., The
FDA FoodClass I
Locatelli Grated Pecorino Romano, 5 and 10-pound plastic bags (units)
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceFDA Devices
FDA DevicesPhilips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
Philips North America Llc
FDA DevicesClass II
Philips Smart-hopping 2.0 AP 1.4 GHz. Patient Monitor.
It was found that the MX40 device could not reconnect to the PIC iX when moving between Radiohead and Trident 1.4 GHz access points if the signal strength changed quickly.
Jan 14, 2026Philips North America Llc
Food & BeverageFDA Food
FDA FoodBoar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Ambriola Co., Inc., The
FDA FoodClass I
Boar's Head Grated Pecorino Romano, 6 oz Plastic Cup & Lid, 12 units per case
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The