Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Medical Device
FDA Devices
FDA DevicesThe Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Roche Diagnostics Operations, Inc.
FDA DevicesClass II
The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Patient serum sample is incubated with pretreatment reagent PT1 and the reconstituted PT2 containing a pre-formed immunocomplex of solubilized porcine TSH receptor (pTSHR) and biotinylated anti-pTSHR mouse monoclonal antibody.
Issues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis, as well as delay of treatment or incorrect treatment.
Jan 14, 2026Roche Diagnostics Operations, Inc.
Food & BeverageFDA Food
FDA FoodSysco 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.
McCain Foods USA Inc
FDA FoodClass II
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.
Jan 14, 2026McCain Foods USA Inc
Food & BeverageFDA Food
FDA FoodTown 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 Equip Co Inc
FDA FoodClass II
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.
Jan 14, 2026Town Food Service Equip Co Inc
Medical DeviceFDA Devices
FDA DevicesBrand 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.
IMRIS Imaging Inc
FDA DevicesClass II
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.
Jan 14, 2026IMRIS Imaging Inc
Medical DeviceFDA Devices
FDA DevicesMedline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
Medline Industries, LP
FDA DevicesClass II
Medline Hudson RCI Medium Concentration Oxygen Masks: 1041CE MASK,OXYGEN,UND CHIN,MED CO OUS ONLY; HUD1035 O2 MASK,MED CONC,SHORT,PEDI,7' TUB SC; HUD1042 O2 MASK,MED CONC,PEDI,7' TUB SC; HUD1930 O2 MASK,MED CONC,ADULT,7' TUB UC; HUDRHO41U MASK,OXYGEN,MEDIUM-CONCENTRATION,7,SC
Firm received multiple complaints regarding tubing disconnecting from oxygen mask. If issue occurs during use, may lead to delay in patient care and patient may experience shortness of breath leading to hypoxia, which may require medical intervention to prevent further respiratory deterioration.
Jan 14, 2026Medline Industries, LP
Medical DeviceFDA Devices
FDA DevicesLUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
Siemens Medical Solutions USA, Inc
FDA DevicesClass II
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471
A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
Jan 14, 2026Siemens Medical Solutions USA, Inc
Medical DeviceFDA Devices
FDA DevicesPhilips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Remote Diagnostic Technologies Ltd.
FDA DevicesClass II
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Patient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for accuracy. If healthcare providers base clinical judgment on unvalidated measurements, this could potentially lead to incorrect clinical decisions.
Jan 14, 2026Remote Diagnostic Technologies Ltd.
Medical DeviceFDA Devices
FDA DevicesHalyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
AVID Medical, Inc.
FDA DevicesClass I
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOG1000-15.
Devices are not suitable for organ transplant.
Jan 14, 2026AVID Medical, Inc.
Food & Beverage
RappelConso
RappelConsovergani - gluten free classic pandoro 600g
vergani
RappelConsovolontaire (san...
vergani - gluten free classic pandoro 600g
présence éventuelle de corps étrangers provenant des contenants utilisés lors du processus de cuisson
Jan 14, 2026vergani
Food & BeverageRappelConso
RappelConsocontrefaçon - disney miniso - porte clé peluche stitch
contrefaçon - disney miniso
RappelConsovolontaire (san...
contrefaçon - disney miniso - porte clé peluche stitch
présence de petits éléments qui peuvent être ingérés par les enfants.
Jan 14, 2026contrefaçon - disney miniso
Medical DeviceFDA Devices
FDA DevicesKii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
Applied Medical Resources Corp
FDA DevicesClass II
Kii Low Profile, Bladed Dual Pack , Qty. 1 5x55mm REF: CTB23
There is the potential for extended length of the blade obturator after assembly into the cannula and seal housing.
Jan 14, 2026Applied Medical Resources Corp
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 FoodEverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)
GBC Food Services, LLC
FDA FoodClass I
EverRoast Chicken Caesar Salad 850042244142 Net Wt: 8.5 oz (255g)
Potential presence of Listeria monocytogenes.
Jan 14, 2026GBC Food Services, LLC
Medical DeviceFDA Devices
FDA DevicesBD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
CareFusion 303, Inc.
FDA DevicesClass II
BD Pyxis ES Enterprise Server Catalog Numbers 1115-00, 137672-02,137672-03 137671-02, 137671-03, 137670-02, 137670-03, 139676-01, 139421-01, 139420-01, 139419-01, 139419-02, 139673-01, 137081-01, 136451-01, 136451-02, 136450-01, 136450-02, 136449-01, 136449-02, 134148-01, 133760-01, 134149-01, 137669-02, 137669-03, 139675-01, 139672-01 139418-01, 139418-02, 136448-01, 136448-02, 137673-02, 137673-03 139422-01, 133744-01, 136452-01, 136452-02, 138551-01, 134157-01 Software Versions: System Versions 1.6.1 - 1.11.0 Server Application Versions ES 5.4X - 5.8.X The BD Pyxis Enterprise Server is a web application intended to configure and manage BD Pyxis ES automated dispensing cabinets (ADC) and associated BD PyxisTM ES products.
Due a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems.
Jan 14, 2026CareFusion 303, Inc.
PharmaceuticalFDA Drugs
FDA DrugsOxycodone 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
SpecGx, LLC
FDA DrugsClass II
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.
Jan 14, 2026SpecGx, LLC
Food & BeverageFDA Food
FDA FoodSam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Ambriola Co., Inc., The
FDA FoodClass I
Sam's Pecorino Romano grated, 1.5 lb Plastic Bags, 12 units per case
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
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
PharmaceuticalFDA Drugs
FDA DrugsORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
Signature Formulations, LLC
FDA DrugsClass II
ORL Kids Natural Toothpaste, Bubblegum Flavor, 4 oz (120ml), ORL Labs, LLC, Scottsdale, Arizona USA
cGMP Deviations
Jan 14, 2026Signature Formulations, LLC
Medical DeviceFDA 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
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
PharmaceuticalFDA Drugs
FDA DrugsDexamethasone 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
Imprimis NJOF, LLC
FDA DrugsClass II
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.
Jan 14, 2026Imprimis NJOF, LLC
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
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 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.