Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,115 results
Food & Beverage
FDA Food
FDA FoodProspector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz
Prospector Popcorn, LLC
FDA FoodClass III
Prospector Popcorn Belgian Chocolate Toffee Gourmet Popcorn 3.5oz
Inaccurately declared nutrients including Iron (understated), and Vitamin D (overstated).
Aug 26, 2026Prospector Popcorn, LLC
Food & BeverageFDA Food
FDA FoodWhole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21212000000, 21211900000, 25138200000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Spicy Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 21212000000, 21211900000, 25138200000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
Food & BeverageFDA Food
FDA FoodOrganic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153
Publix Super Markets, Inc.
FDA FoodClass I
Organic Whole Mixed Berries, Net Wt. 48 oz (3Lb) plastic bag. packed in 6 bags per case of 10 oz each. Keep Frozen. UPC 41415-12153
Due to potential E. coli O145:H28 contamination
Aug 26, 2026Publix Super Markets, Inc.
Food & BeverageFDA Food
FDA FoodProtein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC Not for individual retail sale
Nutrient Foods, LLC
FDA FoodClass II
Protein Cereal Cocoa Crunch. Shelf stable, ready to eat cereal product. 25-year shelf life, metalized poly pillow pouch. Net wt.8.9 oz (252g). 1 pillow pouch per kit. Nutrient, 110 Woodland Ave Reno, NV 89523. No UPC Not for individual retail sale
Soy not declared in the contains statement.
Aug 26, 2026Nutrient Foods, LLC
Food & BeverageFDA Food
FDA FoodWhole Foods Pomegranate Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 27908100000, 27908500000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Pomegranate Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 27908100000, 27908500000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
Food & BeverageFDA Food
FDA FoodProduct is Potato Sourdough Bread and sold under three following names: Potato Market Loaf 20oz. UPC 733163001576, product is sold at grocery stores with paper packaging. Label declares Potato Grand Central Rustic Breads ***A hearty sourdough loaf made with house-roasted potatoes. ***" Potato Table Loaf 20oz. No UPC. Product is sold direct to consumer at Grand Central Cafe stores and wholesalers without paper packaging. Mini Potato Loaf 12oz. No UPC. Product is sold at grocery stores and wholesalers without paper packaging.
Grand Central Bakery - Oregon Inc. dba Grand Central Bakery, Inc.
FDA FoodClass II
Product is Potato Sourdough Bread and sold under three following names: Potato Market Loaf 20oz. UPC 733163001576, product is sold at grocery stores with paper packaging. Label declares Potato Grand Central Rustic Breads ***A hearty sourdough loaf made with house-roasted potatoes. ***" Potato Table Loaf 20oz. No UPC. Product is sold direct to consumer at Grand Central Cafe stores and wholesalers without paper packaging. Mini Potato Loaf 12oz. No UPC. Product is sold at grocery stores and wholesalers without paper packaging.
Foreign object: May contain metal pieces
Aug 26, 2026Grand Central Bakery - Oregon Inc. dba Grand Central Bakery, Inc.
Food & BeverageFDA Food
FDA FoodWhole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 29802800000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
WFM Purchasing, LP
FDA FoodClass I
Whole Foods Medium Pico de Gallo Guacamole Dip, Keep Refrigerated. Packed in various sized clear plastic containers. Product is weighed and a finished product label is applied. Products contain the following PLU Cods located under label bar code: 29802800000. Packed for Whole Foods Market, located at either 1745 W. Market Street, Akron, OH 44313 or 4301 W. William Cannon, Austin, TX 78749.
Salsa and Guacamole products were made with jalapenos that may be contaminated with Salmonella.
Aug 26, 2026WFM Purchasing, LP
Food & BeverageFDA Food
FDA FoodProspector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
Prospector Popcorn, LLC
FDA FoodClass III
Prospector Popcorn Fudge Brownie Gourmet Popcorn 1.5oz and 3.5oz
Inaccurately declared nutrients including Potassium (overstated) and Calcium (overstated).
Aug 26, 2026Prospector Popcorn, LLC
Medical DeviceFDA Devices
FDA DevicesBrand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA
Kico Knee Innovation Company
FDA DevicesClass II
Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software Version: ARVIS Hip and Knee Gap Balance Software v3.3.2 (IN-28200) ARVIS Shoulder Software v2.0.3 (IN-23630) Product Description: The ARVIS system is a computer-controlled navigation system intended to provide intra-operative measurements to the surgeon to aid in selection and positioning of orthopedic implant components. The ARVIS Surgical Navigation System is indicated for assisting the surgeon in the positioning and alignment of implants relative to reference alignment axes and landmarks in stereotactic orthopedic surgery. The system aids the surgeon in making intraoperative measurements such as changes in leg length in Hip Arthroplasty. The system is compatible with straight acetabular impactors and with specific offset impactors, identified in the instructions for use, for which an adapter has been validated. Example orthopedic surgical procedures include but are not limited to: " Total Knee Arthroplasty " Unicompartmental Knee Arthroplasty: Tibial Transverse Resection " Hip Arthroplasty The ARVIS" head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/virtual displayed information should not be relied upon solely for absolute positional/alignment information and should always be used in conjunction with the displayed stereotaxic information. Component: NA
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
Aug 26, 2026Kico Knee Innovation Company
Medical DeviceFDA Devices
FDA DevicesGETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
Maquet Critical Care AB
FDA DevicesClass II
GETINGE Y SENSOR Module, SERVO-U, SERVO-N, Model Number 6693662; part of the SERVO-U/-N continuous ventilator system, for facility use. Maquet Critical Care AB, is a subsidiary of Getinge.
The module did not undergo electrical safety tests and functional tests during production.
Aug 26, 2026Maquet Critical Care AB
Medical DeviceFDA Devices
FDA DevicesDentsply Sirona Capsule Mixer Model No. 5546068
SDI Limited
FDA DevicesClass II
Dentsply Sirona Capsule Mixer Model No. 5546068
Potential for electrical discharge from unit when unplugged.
Aug 26, 2026SDI Limited
Medical DeviceFDA Devices
FDA DevicesLago X
Spectral Instruments Inc
FDA DevicesClass II
Lago X
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Aug 26, 2026Spectral Instruments Inc
PharmaceuticalFDA Drugs
FDA DrugsCyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
American Regent, Inc.
FDA DrugsClass II
Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
Medical DeviceFDA Devices
FDA DevicesBeckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
Beckman Coulter Inc.
FDA DevicesClass II
Beckman Coulter DxC 500i Clinical Analyzer Modules using software version 1.5 or lower: 1) DxC 500 AU Module w/ISE, DxC 500i, Part Number C63522; 2) DxC 500 AU Module, DxC 500i, Part Number C63521; 3) Access 2 Module, DxC 500i, Part Number C13252; DxC 500 AU Clinical Chemistry Analyzers
a software defect in which the Parameter Package (PP) import logic overwrites all predefined calculated test rules, including those previously modified by the user, upon import of a new Parameter Package version. As a result, usercustomized calculated test rules revert silently to their default expressions, potentially generating erroneous patient test results without an explicit error notification. The issue affects instruments running software version 1.5 or lower and only occurs when a new Parameter Package is imported to a system that already has an existing Parameter Package onboard; new installations are not affected.
Aug 26, 2026Beckman Coulter Inc.
Medical DeviceFDA Devices
FDA DevicesBoston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Boston Scientific Corporation
FDA DevicesClass I
Boston Scientific ENROUTE Transcarotid Neuroprotection System Plus, Material Number SR-250-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
Aug 26, 2026Boston Scientific Corporation
Medical DeviceFDA Devices
FDA DevicesSyva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Siemens Healthcare Diagnostics, Inc.
FDA DevicesClass II
Syva EMIT 2000 Quinidine Assay REF: 4Q019UL Contents: 1x28 mL, 1x14mL
Due to unacceptable precision performance exhibited in certain lots of the Emit 2000 Quinidine Assay, which may lead to erroneously elevated quinidine measurements, creating risk of sub-optimal patient treatment, including potential life-threatening cardiac arrhythmias or inadequate antimalarial therapy.
Aug 26, 2026Siemens Healthcare Diagnostics, Inc.
Medical DeviceFDA Devices
FDA DevicesCustom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Paragon 28, Inc.
FDA DevicesClass III
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Aug 26, 2026Paragon 28, Inc.
Food & Beverage
RappelConso
RappelConsost môret - st môret léger 300g
st môret
RappelConsovolontaire (san...
st môret - st môret léger 300g
défaut de goût
Aug 26, 2026st môret
Medical DeviceFDA Devices
FDA DevicesMiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtronic MiniMed, Inc.
FDA DevicesClass II
MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Loaner insulin pumps may have been cleaned with chemically incompatible products that could damage the pump case or keypad, allow moisture ingress, and result in insulin over- or under-delivery, potentially causing hypoglycemia, hyperglycemia, or diabetic ketoacidosis.
Aug 26, 2026Medtronic MiniMed, Inc.
Medical DeviceFDA Devices
FDA DevicesTD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Tobii Dynavox Llc
FDA DevicesClass II
TD Navio Maxi Speech Generating Device Model/Catalog Number: 1000799
Under certain conditions, the battery mounting tabs may become damaged, allowing the battery to move within the device enclosure, potentially leading to an internal short circuit. This may cause localized heating and gas venting within the device enclosure.
Aug 26, 2026Tobii Dynavox Llc
PharmaceuticalFDA Drugs
FDA DrugsAMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
American Regent, Inc.
FDA DrugsClass II
AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, Inc., Shirley, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsSelenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
American Regent, Inc.
FDA DrugsClass II
Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.
PharmaceuticalFDA Drugs
FDA DrugsPEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Shilpa Medicare Limited
FDA DrugsClass II
PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. NDC: 70121-2461-1
Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
Aug 26, 2026Shilpa Medicare Limited
PharmaceuticalFDA Drugs
FDA DrugsniCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
American Regent, Inc.
FDA DrugsClass II
niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT, Mfd by: American Regent, Inc., New Albany, OH 43054.
Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
Aug 26, 2026American Regent, Inc.