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 6, 2026.
2,589of 2,589 medical device recallsshown with your filters
The list
- Medical device recall Abiomed REF: 0052-3006, Introducer Kit for Impella Hemostatic Peel Away Introducer System with Infusion… Due to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along the hub… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportMassachusettsthe one state its words name PublishedJul 22, 2026ClassClass IStatusOngoingWhereMassachusetts
- Medical device recall ABIOMED Impella RP Flex with SmartAssist Set, Pump Set Code 1000323, containing Kit, 23Fr Introducer, 11cm,… A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Set, Pump Set Code 0048-0003, containing BIOMED Impella Introducer, 14 Fr, 13 cm & 25 cm A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Introducer Kit 14 Fr, 13 and 25 cm, Pump Set Code 1000550, containing Kit, 14Fr… A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Introducer Kit 23 Fr, 11 cm, Pump Set Code 1000441, containing Kit, 23Fr Introducer, 11cm, Sterile,… A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Introducer Kit 14 Fr, 13 cm, Pump Set Code 0052-0038, containing Kit, 14Fr Introducer,… A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Introducer Kit 14 Fr, 25 cm, Pump Set Code 0052-0039, containing Kit, 14Fr Introducer,… A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella 5.5 Smart Assist Set, JP, Pump Set Codes 1000211, 1000212 A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella 5.5 SmartAssist S2 Set, JP, Pump Set Codes 1000459, 1000460 A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Set, Pump Set Code 0048-0014 A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Smart Assist Set, JP, Pump Set Code 0048-0024-JP A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Impella CP Set, Pump Set Code 0048-0044 A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Insertion Kit, Pkgd, JP, Pump Set Code 0052-0011-JP A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall ABIOMED Intro Kit, 14Fr x 13 and 25 cm, PKGD, JP, Pump Set Code 0052-0023-JP A potential for introducer sheath leakage from under the sheath cap and along the hub score lines, identified in 14Fr and 23Fr Introducers. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 4 states named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and California, Delaware, Illinois and Pennsylvania named
- Medical device recall Transvenous Pacing Electrode Tray w/ Bipolar Balloon Pacing Electrode 5F Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall One-Piece Introducer Tray Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall General Biospy Tray Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall T-Lok Bone Marrow Tray Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Arterial Line Kit 20ga x 6 Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Bone Marrow Tray Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 22, 2026ClassClass IStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall Olympus Toomey Evacuator 30cc with Adaptor Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Toomey Evacuator 50cc with Adaptor Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Ellik Evacuator Includes Glass Body, Male Connecting Tubing & Latex Bulb Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Glass Body for 194 Ellik Evacuator Some sterilization parameters included in the IFU may not consistently render the devices adequately sterile and therefore should no longer be used to… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall da Vinci SP Instrument Arm Drape, SP, 1-PACK Robotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the product,… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ICU Medical Plum Solo Precision IV Pump, v1.0.3 In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Rapid Refill Continuous Injection System, UPN M00566001 Devices contain recalled Medline Namic Angiographic Control Syringe with Rotating Adaptor. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optima XR200amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optima XR220amx, Mobile Digital-Ready Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Optima XR240amx, Mobile Digital Radiographic System GE HealthCare has become aware that in certain Optima XR200/220/240amx systems that have had a column replacement completed, functional testing of the safety… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Orthofix MINIRAIL, STANDARD LENGTHENER Unilateral external fixation devices may be incorrectly labeled. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Orthofix MINIRAIL, SHORT, LENGTHENER Unilateral external fixation devices may be incorrectly labeled. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Orthofix ARTICULATED MINIRAIL FIXATOR HORIZONTAL AXIS Unilateral external fixation devices may be incorrectly labeled. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Orthofix MINIRAIL, ARTICULATED, FIXATOR, VERTICAL AXIS Unilateral external fixation devices may be incorrectly labeled. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement Report26 statesnamed in where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereArizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Louisiana, Maryland, Michigan, Missouri, Mississippi, Montana, North Carolina, New York, Ohio, Oregon, South Carolina, South Dakota, Texas, Utah, Virginia, Washington and Wisconsin
- Medical device recall Papablic Replacement Brush Heads Potential for brush heads to break. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Papablic Replacement Brush Heads Potential for brush heads to break. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK DYNJT6267 Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Utah named
- Medical device recall Medline Kits containing Zimmer Biomet mixing bowls and spatulas TOTAL KNEE PACK-LF DYNJ61651J Kits contain Zimmer Biomet mixing bowls and spatulas, which were recalled due to seal nonconformities which present risk of sterility breach. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and California and Utah named
- Medical device recall Medtronic DLP One-Piece Pediatric Arterial Cannula, Product Number/CFN 77010 Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Maryland, Michigan, North Carolina, Pennsylvania and Washington named
- Medical device recall Medtronic Bio-Medicus Adult Cannula Kit, Product Number/CFN 96530-115 Medtronic received two complaints of loose foreign material confirmed as containing trace levels of blood. Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Florida, Maryland, Michigan, North Carolina, Pennsylvania and Washington named
- Medical device recall Brand Name: Rio” II Product Name: Rio” II Nasal Pillows Interface Packaging and labeling discrepancy involving product size identification and associated Unique Device Identifier (UDI/GTIN). Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The Vasoview Hemopro 2 Endoscopic Vessel Harvesting System (Model VH-4000 Getinge identified that Vasoview Hemopro 2 devices from Lot 3000547797 were exposed to an out-of-specification sterilization dose during a gamma sterilization… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, New York, Oregon, South Carolina and Texas named
- Medical device recall Photera 400, phototherapy device Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be “4/5” instead of “7” (counts were at ~1000… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Photera 600, phototherapy device Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be “4/5” instead of “7” (counts were at ~1000… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Photera 600 3-D, phototherapy device Calibrated Output was not calculating correctly - UV Sensor GAIN being applied was incorrect - GAIN seemed to be “4/5” instead of “7” (counts were at ~1000… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall ST AIA-Pack Testosterone, IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of testosterone in… The Test cup lot F level 1 low-quality control results values for the device were lower than expected on the Automated Immunoassay Analyzer (AIA) which could… Class IIFDA’s classJul 22, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 22, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Single Use Distal Cover Olympus has developed and released newly designed version of the Distal Cover (MAJ-2315) to replace previous design of the Single Use Distal Covers. Class IIFDA’s classJul 15, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 15, 2026ClassClass IIStatusOngoingWhereNationwide
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.”
Your shortlist0 of 4
Add one more to compare.