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 7, 2026.
2,908of 2,908 medical device recallsshown with your filters
The list
- Medical device recall Temporary Titanium Abutments Certain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium abutment,… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 48 states named PublishedFeb 12, 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, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall Access PCT Reagent Pack Identified reagent lots are experiencing a high rate of calibration failures with failure code of “Max Iterate” on Access 2 and UniCel Dxl Immunoassay Systems. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Sysmex PS-10 Sample Preparation System with software version 1.5 and 1.6. Sysmex was made aware of a report of false results due to carry-over caused by the sporadic omission of the probe wash step during antibody pipetting on the… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brasseler ESR Rotary/Reciprocating Endodontic File Device Due to devices being irradiated above the established specification which my result in package integrity issues. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereNationwide, and Georgia named
- Medical device recall Beckman Coulter DxI 9000 Access Immunoassay Analyzer A software error caused an increase in tray gripper motion errors that causes intermittent hard stops and a delay in patient results. Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 12, 2025ClassClass IIStatusCompletedWhereNationwide
- Medical device recall UNiD” Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two… Due to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i incorrect… Class IIFDA’s classFeb 12, 2025in FDA’s Enforcement Report50 statesnamed in where it went PublishedFeb 12, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, 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, Washington, Wisconsin, West Virginia and Wyoming
- Medical device recall ARTIS One Angiographic X-Ray System A potential issue with ARTIS One systems was identified. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline General Surgery Tray Kits: 1) ARTERIAL LINE INSERTION KIT The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline General Surgery Tray kits: 1) ARTERIAL LINE TRAY The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. FDA Class I, its most serious class Class IFDA’s class (needs attention)Feb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IStatusOngoingWhereNationwide
- Medical device recall HemosIL Heparin Calibrators Control indicating lower than expected quality control (QC) results and in some instances QC recovery below the lower limit of the package insert acceptance… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Design Options COMBINED SPINAL/EPIDURAL TRAY- Intended for administration of analgesic/anesthetic agent to… Incorrect catheter connector within the kit resulting in inability to provide a secure connection to the epidural catheter. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Missouri and Oklahoma named
- Medical device recall Medtronic PIN, 100mm STERILE PERCUTANEOUS Due to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedFeb 5, 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
- Medical device recall CyberKnife Treatment Delivery System Snap rings may become partially or completed detached from the shafts within the internal mechanism. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusCompletedWhereNationwide
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553640 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553650 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553660 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553670 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553680 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553690 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Delivery System 10mmx10mm UPN: M00553740 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall AXIOS Stent and Delivery System 15mmx10mm UPN: M00553750 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 6mmx8mm UPN: M00553520 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 8mmx8mm UPN: M00553530 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 10mmx10mm UPN: M00553540 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx10mm UPN: M00553550 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 20mmx10mm UPN: M00553560 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall HOT AXIOS Stent and Electrocautery- Enhanced Delivery System 15mmx15mm UPN: M00553570 Reported Outer sheath distal black tip detaching from the device can remain around the stent saddle, preventing proper expansion, resulting in prolongation of… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and Puerto Rico named
- Medical device recall NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Purple/C,D - Height 14 mm It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kansas, Missouri, Nebraska, New Jersey, Pennsylvania and Tennessee named
- Medical device recall NexGen LCCK Legacy Articular Surface with Locking Screw - Striped Yellow/E,F - Height 10 mm It was identified internally that two commingle events occurred where the metal support post within the polyethylene articular surface was assembled… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 9 states named PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Georgia, Kansas, Missouri, Nebraska, New Jersey, Pennsylvania and Tennessee named
- Medical device recall Medline procedure kits labeled as: 1) Port Access Kit, Reorder number CVI5130 Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188 Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline procedure kits labeled as: 1) CENTRAL LINE DRESSING KIT, Reorder number DYNDC3189 Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall CENTURION Infusion Catheter, 7F, 17cm (DO), Reorder MIC17F7 Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereFlorida, Illinois, Kansas, North Dakota, Pennsylvania, Washington and West Virginia
- Medical device recall MEDLINE ARTERIAL LINE PACK Certain lots Sterile Infusion Catheters which were mislabeled as having a heparin coating were either distributed or manufactured into medical convenience kits… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement Report7 statesnamed in where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereFlorida, Illinois, Kansas, North Dakota, Pennsylvania, Washington and West Virginia
- Medical device recall BD Pyxis MedStation ES AUX Tower Due to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory… Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement Report54 statesnamed in where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereAlaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, 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
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall KARL STORZ - ENDOSKOPE Scope IFUs contain a reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Class IIFDA’s classFeb 5, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedFeb 5, 2025ClassClass 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.”
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