Medical devices
Shortlist up to four to read them side by side.
2,589 medical device recalls FDA’s Enforcement Report published in 2026, the newest year, 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 7, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Paradigm Insulin Pump (MMT-712, MMT-715) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Paradigm REAL-Time Insulin Pump (MMT-522, MMT-722) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Paradigm REAL-Time Revel Insulin Pump (MMT-523, MMT-723) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MiniMed 530G Insulin Pump (MMT-551, MMT-751) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Paradigm REAL-Time Veo Insulin Pump (MMT-554, MMT-754) All Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and under-delivery of… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 53 states named PublishedApr 8, 2026ClassClass 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, US Virgin Islands, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Burlington Medical, Thyroid Shield. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Vest Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Kilt Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Frontal Aprons Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Wrap Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, BAT (Breast, Axilla and Thyroid) Coverage. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Protective Sleeves. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Caps. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Leg Wraps. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Half Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Demi Half Aprons. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Blockers. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Burlington Medical, Kilt Blockers. Potential for attenuation degradation over time, decreasing the lifespan. Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall OXOID MICROBACT IDENTIFICATION KITS, Listeria 12L Kit, 20 Tests Oxoid Ltd., part of Thermo Fisher Scientific, confirmed that Microbact 12L Kit 20 Tests MB1128A lot 4494873 may identify incorrect organism due to inconclusive… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Georgia named
- Medical device recall SIGNA Premier systems Whole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with ferrous… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Massachusetts, New Jersey, New York, Ohio, Puerto Rico, South Dakota, Texas and Virginia named
- Medical device recall Cardinal Health Monoject Tuberculin Syringe, 1 mL Luer Lock The outer packaging and blister pack labeling identify the product as 1mL Luer Lock Tuberculin Syringe (Product Code 1180100777), however the syringes… Class IIFDA’s classApr 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Flexible Cryoprobe (OD 1.1mm, L1.15mm) w/ oversheath (OD2.6mm, L817mm) Probes may rupture/burst during activation FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flexible Cryoprobe (OD 1.7mm, L1.15mm) Probes may rupture/burst during activation FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Flexible Cryoprobe (OD 2.4mm, L1.15mm) Probes may rupture/burst during activation FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall CentrosFLO Hemodialysis Catheters 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ProGuide Chronic Dialysis Catheters 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall 16F Dual Valved Splittable Sheath Introducer (bulk, non-sterile) 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall DuraMax Chronic Hemodialysis Catheter 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BioFlo DuraMax Catheter 16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 43 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Handy Solutions Neck & Shoulders Heating Pad, Number: 25607 If heating pad is folded while in use, the power density increases in the folded area causing excessive temperatures, which can also be caused by placing pad… FDA Class I, its most serious class Class IFDA’s class (needs attention)Apr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedApr 1, 2026ClassClass IStatusOngoingWhereNationwide, and California, Florida, Indiana, Louisiana, Mississippi, Texas and Virginia named
- Medical device recall Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems There is a potential issue that can lead to discordance between the simulated needle trajectory/tip position and the actual needle trajectory/tip position. Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Volar Radius Plate with Angular Stability with the following description: Radius Plate PROlock II Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Claviculaplate with Angular Stability, with the below descriptions and associated article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Brand Name: Humeral Head Plate with Angular Stability, with the following description: Proximal Humeral Plate Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall FR.O.H. Calcaneus Repair System with the following description: Anterolateral Calcaneus Plate. Article… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Pilonplate with Angular Stability, with the below descriptions and corresponding article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Olecranonplate with Angular Stability with the below descriptions and corresponding article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall I.T.S. Straight Plate with Angular Stability with the below descriptions and corresponding article numbers.… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall I.T.S. Screw System with the below descriptions and corresponding article numbers. 1. Cancellous Screw,… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Pelvic Reconstruction System (PRS) with the below descriptions and corresponding article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall I.T.S. Fibula Plate PROlock with Angular Stability with the below descriptions and corresponding article… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Distal Humeral Plates with Angular Stability with the below descriptions and corresponding article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall I.T.S. LRS (Locking Reconstruction System) with the below descriptions and corresponding article numbers. 1.… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall I.T.S. DUL (Distal Ulna Locking) System and UOL (Ulna Osteotomy Locking) System with the below descriptions… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall FLS - Foot Locking Plates System and HOL - Hallux Osteotomy Locking Plate with the below descriptions and… Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall HCS - Headless Compression Screw System, Headless Compression Screw, Cannulated Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall HLS - Hand Locking Plates System with the below descriptions and corresponding article numbers. 1 Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
- Medical device recall Brand Name: I.T.S Updated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the Instructions for… Class IIFDA’s classApr 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 29 states named PublishedApr 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, Ohio, Oklahoma, Pennsylvania, South Carolina, Texas, US Virgin Islands and West Virginia named
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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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