Safety Recall Directory
Browse and filter the latest official safety alerts globally.
Showing 24 of 74,114 results
Medical Device
FDA Devices
FDA DevicesCardiac Workstation 7000. Product Number: 860441.
Philips North America Llc
FDA DevicesClass II
Cardiac Workstation 7000. Product Number: 860441.
Device will intermittently provide inaccurate data related to native heart rate.
Aug 26, 2026Philips North America Llc
Medical DeviceFDA Devices
FDA DevicesArrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.
Arrowhead DE LLC
FDA DevicesClass II
Arrow-LOK Implant, REF: 21-253519, 21-253522, 21-253525, 21-253528, 21-253530, 21-253533, 21-253535, 21-253540, 21-253545, 21-253550, 21-353513, 21-353516, 27-253519, 27-253522, 27-253525, 27-253528, 27-253530, 27-253533, 27-253535. Implant indicated for fixation of osteotomies, arthrodeses and reconstruction in the lesser toes following corrective procedures.
Implant did not undergo required gamma radiation dose audit. A potential reduction in sterility assurance could lead to patient infection.
Aug 26, 2026Arrowhead DE LLC
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 Salsa, Heirloom Tomato. 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: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. 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 Salsa, Heirloom Tomato. 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: 22860200000, 24091700000, 24118800000, 25024800000, 29648100000, 29648700000, 46000049560. 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
Medical DeviceFDA Devices
FDA DevicesMiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
Medtronic MiniMed, Inc.
FDA DevicesClass II
MiniMed 640G Insulin Pump, Model: MMT-1711, MMT-1712;
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 DevicesInnercool Coolblue Console, Model STx; Thermal regulating system.
Gentherm Medical, LLC
FDA DevicesClass II
Innercool Coolblue Console, Model STx; Thermal regulating system.
Overheating of the 115V CPU board may cause the device to shut down.
Aug 26, 2026Gentherm Medical, LLC
Food & BeverageFDA Food
FDA FoodWhole Foods Mild Guacamole Dip No Tomatoes, 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: 24293900000, 25745000000, 24367500000, 25658600000, 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 Mild Guacamole Dip No Tomatoes, 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: 24293900000, 25745000000, 24367500000, 25658600000, 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 DevicesTD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
Tobii Dynavox Llc
FDA DevicesClass II
TD Navio Midi Speech Generating Device Model/Catalog Number: 1000798
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
Medical DeviceFDA Devices
FDA DevicesFort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
Fort Defiance Industries, LLC
FDA DevicesClass II
Fort Defiance Industries (FDI), Automated Field Steam Sterilizer REF: P2131
The Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which could result in an unreliable fault current return path.
Aug 26, 2026Fort Defiance Industries, LLC
Medical DeviceFDA Devices
FDA DevicesHamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Foundation Medicine, Inc.
FDA DevicesClass II
Hamilton Microlab STAR Liquid Handler; Protocol Configuration Tool (PCT) v2.0.0. Used to conduct F1CDx and F1LCDx.
Software issue that can cause an increase in spontaneous software closures.
Aug 26, 2026Foundation Medicine, Inc.
Medical DeviceFDA Devices
FDA DevicesBoston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Boston Scientific Corporation
FDA DevicesClass I
Boston Scientific ENROUTE Transcarotid Neuroprotection System, Material Number SR-200-NPS; Percutaneous catheter
Potential for arterial sheath tip separation or partial tip separation during use.
Aug 26, 2026Boston Scientific Corporation
Medical DeviceFDA Devices
FDA DevicesBeckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; DxC 500 AU Clinical Chemistry Analyzers
Beckman Coulter Inc.
FDA DevicesClass II
Beckman Coulter DxC 500 AU Clinical Analyzer Modules using software version 1.5 or lower: 1) AU w/out ISE, Part Number C63519; 2) AU w/ISE, Part Number C63520; 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.
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.
Medical DeviceFDA Devices
FDA DevicesBlanketrol II Model 222S; Thermal regulating system.
Gentherm Medical, LLC
FDA DevicesClass II
Blanketrol II Model 222S; Thermal regulating system.
Overheating of the 115V CPU board may cause the device to shut down.
Aug 26, 2026Gentherm Medical, 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
PharmaceuticalFDA Drugs
FDA DrugsLibtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
Regeneron Pharmaceuticals Inc
FDA DrugsClass II
Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Regeneron Pharmaceuticals, Inc. (Tarrytown, NY 10591), NDC 61755-008-01
Lack of Assurance of Sterility
Aug 26, 2026Regeneron Pharmaceuticals Inc
Food & BeverageFDA Food
FDA FoodOrganic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753
Publix Super Markets, Inc.
FDA FoodClass I
Organic Whole Mixed Berries, Net Wt. 10 oz (284 g) plastic bags, packed in 8 bags per case of 10 oz each. Keep Frozen. UPC 41415-06753
Due to potential E. coli O145:H28 contamination
Aug 26, 2026Publix Super Markets, Inc.
Food & BeverageFDA Food
FDA FoodGet Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
GET FRESH PRODUCE
FDA FoodClass I
Get Fresh Produce Jalapeno Peppers. Item 01896 - 2 lb. box; Item 01894 - 10 lb. box
Potential Salmonella contamination
Aug 26, 2026GET FRESH PRODUCE
Medical DeviceFDA Devices
FDA DevicesAmi HTX
Spectral Instruments Inc
FDA DevicesClass II
Ami HTX
Momentary absence of On-Screen "X-Ray On" banner during run readiness check.
Aug 26, 2026Spectral Instruments Inc
Food & BeverageFDA Food
FDA FoodVITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLIC
Lidl US TRADING
FDA FoodClass I
VITASIA ASIAN STYLE WOK SPICE MIX NET WT 1.58 OZ (45g) UPC 4 335619 355491 DISTRIBUTED BY LIDL US, LLC ARLINGTON, VA 22202 PRODUCT OF THE CZECH REPUBLIC
Salmonella. The firm received a positive test result of Salmonella in the product.
Aug 26, 2026Lidl US TRADING
PharmaceuticalFDA Drugs
FDA DrugsNitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
American Regent, Inc.
FDA DrugsClass II
Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) 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.
Food & BeverageFDA Food
FDA FoodWhole Foods Mild 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: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) 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 Mild 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: 21211600000, 21501700000, 25705700000, 25054100000, 25926000000 (part of Dip Trio) 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
Medical DeviceFDA Devices
FDA DevicesAmerican Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
American Contract Systems Inc
FDA DevicesClass II
American Contract Systems medical procedure kits and trays labeled as: 1) ANTERIOR CERVICAL PACK - 205988, Model Item Number MHAC65AH; 2) SPINE PACK - 206013, Model Item Number MHSP99AF.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
Aug 26, 2026American Contract Systems Inc