Medical devices, 2025
Shortlist up to four to read them side by side.
2,908 medical device recalls FDA’s Enforcement Report published in 2025, newest first; 40,450 in all since 2012.
FDA’s medical device recalls, as its Enforcement Report classifies them, from June 2012. Lists of FDA’s records can’t be saved for alerts: openFDA asks that its data not be used to alert the public (openFDA); FDA’s own emails do that. Copied Nov 6, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Volcano Visions Digital IVUS Catheter: PV.014P (Platinum) Reports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or guide… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Brand Name: Osteotec Product Name: Osteotec Silicone Finger Implant There is the potential that the silicone implant may contain foreign material Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall Blood Agar,5% Sheep Blood 100/PK, Product Number R01202 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Strep Selective II Agar, Product Number R01859 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blood/EMB, Levine 100/PK, Product Number R02041 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Blood/MacConkey Biplate 100/PK, Product Number R02049 The products may contain surface and subsurface contamination of Listeria monocytogenes. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall RAPIDPoint 500 Systems Wash/Waste Cartridge Siemens Healthcare Diagnostics is recalling the RAPIDPoint 500 Systems Wash/Waste Cartridge Lot WW/08925 due to a manufacturing error causing positive and… Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 3M Ranger Irrigation Fluid Warming Set Notice was issued to clarify flow rates related to the inlet fluid temperature. Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Y-Site (Qty 25) Potential for external cassette leaks Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LVP Blood Products Administration Set Dual-Inlet, Low-Sorbing, Y-Site, Mesh Filter (Qty 20) Potential for external cassette leaks Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LVP Primary Administration Set, Single Outlet Low Sorbing (Qty 25) Potential for external cassette leaks Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25) Potential for external cassette leaks Class IIFDA’s classAug 6, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 21 states named PublishedAug 6, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Delaware, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Mississippi, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin named
- Medical device recall Portable X-ray system Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall SIGNA Architect GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA Architect AIR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Discovery MR750w 3.0T GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall SIGNA PET/MR GE HealthCare has become aware that gradient coils for certain MR systems (see affected product list in this letter), under specific conditions, can produce… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Azurion 7 M20 Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, District of Columbia, Delaware, Florida, Illinois, Indiana, Kentucky, Massachusetts, Maryland, Minnesota, Missouri, Montana, New Jersey, Nevada, New York, Ohio, South Carolina, Texas and Washington named
- Medical device recall HSG Procedure Tray The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Endosee System Convenience Kit The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Endosee System Convenience Kit with IV Tube The HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify the… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Natus Brain Monitor Breakout Box Natus received two complaints of left side labeling show impedance for right side. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereCalifornia, Indiana, Missouri, North Carolina, Pennsylvania, Rhode Island and Texas
- Medical device recall Blue Silicone, Reusable Silicone Seal 6 - 12 FR Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Green Silicone Seal for Accessories, Reusable Silicone Seal 0 - 7 FR Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Glass Body For 194 Ellik Evacuator Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Tubing for Male Connector 194, Ellik Evacuator Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ellik Evacuator Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ellik Latex Bulb, Ellik Evacuator Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Ellik Evacuator Adapter, Locking Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Cone with Male Tubing, Non-Locking, Ellik Evacuator Discrepancies between sterilization instructions in the Japanese language product package inserts and those published in the manufacturer product Instructions… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Brand Name: EMPOWR Dual Mobility” Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereAlabama, California, Florida, Indiana, Louisiana, Maryland, Michigan, North Carolina, New York, Tennessee, Texas, Utah and Virginia
- Medical device recall Brand Name: EMPOWR Dual Mobility” Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD42 Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report13 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereAlabama, California, Florida, Indiana, Louisiana, Maryland, Michigan, North Carolina, New York, Tennessee, Texas, Utah and Virginia
- Medical device recall Bodor’s I series laser cutting machine. The Bodor i Series products fail to meet certain applicable Federal standards, 21 CFR 1040.10(f)(1) and 21 CFR 1040.10(f)(2). Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Covidien Nellcor Bedside SpO2 Patient Monitoring System Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure,… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Estrone RIA, REF: DSL8700. Estrone RIA is an IVD used for the quantitative measurement of estrone in human… A specific lot of bovine serum albumin (BSA) used for manufacturing of coated tubes (CT) that are included in the Estrone RIA kit lots caused different… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNorth Carolinathe one state its words name PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNorth Carolina
- Medical device recall Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: LABOR TRIAGE KIT Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Pennsylvania and Texas
- Medical device recall Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: IV START KIT LAB… Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Pennsylvania and Texas
- Medical device recall Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: 1) BLOOD CULTURE KIT Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Pennsylvania and Texas
- Medical device recall Medline Convenience Kits, containing BD ChloraPrep Clear - 1mL Applicator, labeled as: C-SECTION PREP Affected convenience kits contain BD ChloraPrep Clear - 1 mL Applicators, which were recalled by BD due to potential to exhibit an open seal on its packaging. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report4 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereCalifornia, Florida, Pennsylvania and Texas
- Medical device recall Bridge to Life EasiSlush, (Sodium Chloride Solution for Sterile Slush Preparation) The firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the first… Class IIFDA’s classJul 30, 2025in FDA’s Enforcement Report16 statesnamed in where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereAlabama, Arizona, California, Florida, Georgia, Maryland, Minnesota, North Carolina, Nebraska, New Jersey, New York, Ohio, South Carolina, Tennessee, Utah and Wisconsin
- Medical device recall BD COR System Software Potential for functionality issue that supports the Over labeling feature and could lead to possible false negative results. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Florida, Michigan and Texas named
- Medical device recall ACUVUE¿ OASYS MAX 1-Day MULTIFOCAL Due to defects (bubbles/voids) identified during standard finished goods testing Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 32 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Delaware, Florida, Georgia, Hawaii, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Missouri, North Carolina, New Jersey, Nevada, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming named
- Medical device recall Biofinity XR Toric Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Biofinity Toric Multifocal Contact Lens Lens blisters may have an incomplete or leaking seal which may render them unsterile. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic CareLink SmartSync Patient Connector In prior SmartSync application versions, the Abort button stopped the test that was selected. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic CareLink SmartSync Device Manager In prior SmartSync application versions, the Abort button stopped the test that was selected. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker, StrykeFlow Due to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. Class IIFDA’s classJul 30, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJul 30, 2025ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
Nothing matches all of these.
Remove a filter to see more. Each one is a fact FDA’s record publishes, so a recall can be left out because its record is silent on it.
Source:
FDA, Device recall enforcement reports. Released Nov 3, 2026. Updated weekly.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.”
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