Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Intellis AdaptiveStim Product Number 97715, Spinal Cord Stimulator inability to reprogram one device Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Thoratec HeartMate 3, LVAS Implant Kit Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMay 8, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Thoratec HeartMate 3, LVAS Implant Kit Potential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. FDA Class I, its most serious class Class IFDA’s class (needs attention)May 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedMay 8, 2024ClassClass IStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Keller Funnel 2 Their is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedMay 8, 2024ClassClass 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 Abbott Aveir Leadless Pacemaker Their is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and 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 and West Virginia named
- Medical device recall OsmoPRO MAX Automated Osmometer- IVD Osmometer for Clinical Use System error messages may delay the ability to test patient samples and the need for frequent calibration due to results outside the expected range when… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sofsilk Braided Silk sutures, Product Number S-2782K One lot of product was exposed to more than the approved number of Ethylene Oxide (EO) sterilization cycles. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Blade, Part # 01-06-4 Potential shearing of the disposable blade may occur and be contained within the of Flexible Curette Shaft Assembly during surgery. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMay 8, 2024ClassClass IIStatusCompletedWhereNationwide, and Minnesota named
- Medical device recall POWERSEAL 5 mm, 23 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery… Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall POWERSEAL 5 mm, 37 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery… Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall POWERSEAL 5 mm, 44 cm, Curved Jaw Sealer and Divider, Double Action is indicated for use in general surgery… Upon initial activation of the seal function, the POWERSEAL non-conformance results in an immediate Incomplete Seal Cycle tone with the accompanying message on… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Abbott Cholestech LDX Battery Kit There is a potential that the Cholestech LDX battery (an external battery pack available as an optional accessory to the Cholestech LDX Analyzer) may swell… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall IPS e.max ZirCAD CER/in Defective blocks may show cracks after sintering If cracks are unnoticed, restorations may fracture in the patient’s mouth and require restoration Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 12 Holes, 184 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 16 Holes, 236 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Sterile- Indicated for temporary internal fixation… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Sterile-… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP(Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 12 Holes, 184 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 14 Holes, 210 MM, Sterile- Indicated for temporary internal fixation… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Left, 16 Holes, 236 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP (Zimmer Periarticular Locking Plate System) Distal Lateral Fibular Plate, Right, 4 Holes, 80 MM,… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Right, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Right, 8 Holes, 132 MM, Nonsterile- Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Right, 10 Holes, 158 MM, Nonsterile- Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 4 Holes, 80 MM, Nonsterile- Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 6 Holes, 106 MM, Nonsterile- Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 8 Holes, 132 MM, Nonsterile-Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ZPLP Distal Lateral Fibular Plate, Left, 10 Holes, 158 MM, Nonsterile-Indicated for temporary internal… Thread form issue for the locking holes in that the locking screws may not properly mate with the plate. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medtronic Invos, Reusable Infant Sensor Adapter Cable for PM7100 manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel Class IIFDA’s classMay 8, 2024in FDA’s Enforcement Report25 statesnamed in where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Medtronic Invos, Reusable Sensor Cable for PM7100 manufacturing defects to sensor cable connectors may result in error codes or non-functioning channel Class IIFDA’s classMay 8, 2024in FDA’s Enforcement Report25 statesnamed in where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereAlaska, Arizona, California, Connecticut, Florida, Georgia, Iowa, Indiana, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington and Wisconsin
- Medical device recall Galaxy System Due to a misaligned calibration of the wired controller that may result in unintended motion of the scope. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Indiana, Maryland, Missouri, Ohio and Pennsylvania named
- Medical device recall Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr. Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr. Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr. Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users… Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Distal Access Catheter is a single-lumen, braided shaft, variable stiffness catheter with radiopaque… Stryker Neurovascular is recalling their DAC- Distal Access Catheter -038 136cm, a Distal Access Catheter by removal. Class IIFDA’s classMay 8, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 12 states named PublishedMay 8, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Colorado, Florida, Illinois, Louisiana, Michigan, Mississippi, North Carolina, New Jersey, Pennsylvania, South Carolina and Texas 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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