Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,116 results
Food & Beverage
FDA Food
FDA FoodMARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green printing. UPC is 0 41735 01358 3. Product of Indonesia. PROUDLY DISTRIBUTED BY PRICE CHOPPER, INC. SCHENECTADY, NY 12306.
DIRECT SOURCE SEAFOOD LLC
FDA FoodClass II
MARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green printing. UPC is 0 41735 01358 3. Product of Indonesia. PROUDLY DISTRIBUTED BY PRICE CHOPPER, INC. SCHENECTADY, NY 12306.
Shrimp may be contaminated with Cesium-137 (Cs-137).
Jan 14, 2026DIRECT SOURCE SEAFOOD LLC
Medical DeviceFDA Devices
FDA DevicesHalyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
AVID Medical, Inc.
FDA DevicesClass I
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Devices are not suitable for organ transplant.
Jan 14, 2026AVID Medical, Inc.
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 Pecorino Romano Grated, 5-pound plastic bag (unit)
Ambriola Co., Inc., The
FDA FoodClass I
Boar's Head Pecorino Romano Grated, 5-pound plastic bag (unit)
Product tested positive for Listeria Monocytogenes.
Jan 14, 2026Ambriola Co., Inc., The
Medical DeviceFDA Devices
FDA DevicesHalyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
AVID Medical, Inc.
FDA DevicesClass I
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Devices are not suitable for organ transplant.
Jan 14, 2026AVID Medical, Inc.
Medical DeviceFDA Devices
FDA DevicesBeckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; Immunoassay Method, Troponin Subunit
Beckman Coulter, Inc.
FDA DevicesClass II
Beckman Coulter UniCel Dxl 800, Part numbers: 973100, A71456, A71457, A25288; 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 DevicesImpella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Abiomed, Inc.
FDA DevicesClass II
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.
Device packaged in incorrect outer box carton.
Jan 14, 2026Abiomed, Inc.
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
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
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 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
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
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.
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
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
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 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 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 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
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
PharmaceuticalFDA Drugs
FDA DrugsTri-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.
Imprimis NJOF, LLC
FDA DrugsClass II
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.
Jan 14, 2026Imprimis NJOF, LLC
PharmaceuticalFDA Drugs
FDA DrugsRosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
AvKARE
FDA DrugsClass II
Rosuvastatin Tablets, USP, 10 mg, Rx Only, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC: 50268-709-15
Out of specification for dissolution.
Jan 14, 2026AvKARE
PharmaceuticalFDA Drugs
FDA DrugsFesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Alembic Pharmaceuticals Limited
FDA DrugsClass III
Fesoterodine Fumarate, Extended-release Tablets, 8 mg, 30 Tablets, Rx only, Manufactured by: Alembic Pharmaceuticals Limited, Panelav 389350, Gujarat, India, Manufactured for: Alembic Pharmaceuticals, Inc., Bedminster, NJ 07921, USA, NDC 62332-176-30
Failed Impurities/Degradation Specifications: Due to levels of 'Diester Impurity' exceeding the specification limit.
Jan 14, 2026Alembic Pharmaceuticals Limited