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 smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.87,,O.D. The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, Silicone Catheter, 2.8mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, PolyFlow Polyurethane Catheter, 2.6mm O.D. The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, PolyFlow Catheter, 2.6 The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm… The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, Pre-assembled with PolyFlow Polyurethane Catheter, 2.6mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Plastic Venous Access System, Implantable Venous Access Systems, 82-24 The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Low Profile Plastic Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall smiths medical ProPort Low Profile Plastic Venous Access System, Silicone Catheter, 2.8mm The plastic port housing and port reservoir of the ProPort Plastic Implantable Ports may separate because of a manufacturing defect. FDA Class I, its most serious class Class IFDA’s class (needs attention)Mar 26, 2025in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMar 26, 2025ClassClass IStatusOngoingWhereNo state named
- Medical device recall LAPAROSCOPY PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DR DIULUS INJECTION PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall HIP SCOPE, Model Nos. CCHS21B CCHS21B-01 CCHS21B-02 ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall MAJOR DIEP, Model Nos. CCMJ73G-01 CCMJ73H ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall CYSTO PACK , Model N. HKCY31A ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall C-SECTION PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LAPAROSCOPY PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LABOR & DELIVERY PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall OPEN HEART ADULT - SIDE A ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall GENERAL ANGIO PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall BORN ON ARRIVAL KIT ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall C-SECTION PPS ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall CENTRAL LINE PICC ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LABOR & DELIVERY PPS ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall URO ROBOTIC PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall CYSTO , Model No SACY80R ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall TOTAL HIP PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DELIVERY PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LACERATION TRAY ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LACERATION TRAY ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall EAR PACK , Model No SFEA12A ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall LAPAROSCOPY PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall CV BASIC PUMP PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall DIAGNOSTIC NEURO IR TRAY ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall NEURO IR TRAY ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall AV FISTULA , Model No UTAV77T ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall GENERAL LAPAROSCOPIC PACK-LF ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall MAJOR VASCULAR PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall OPEN HEART A PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall SPINE LUMBAR PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall THORACIC PACK ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall VEIN TRAY, Model No UTVT21C UTVT21C02 UTVT21C-03 ACS is unable to confirm product sterilization assurance requirements were met. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide, and Ohio named
- Medical device recall Proxima Drape labeled as DRAPE C-SECTION W/ WINDOW Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Proxima Drape labeled as PACK,BASIC,SIRUS,V,5/CS Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Proxima Drape labeled as ENT-PLASTICS PACK Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 2025ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Proxima Drape labeled as MINOR PACK and LAPAROSCOPY Potential breach in pouch packaging which could lead to loss of sterility. Class IIFDA’s classMar 26, 2025in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMar 26, 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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