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 Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: CERVICAL PACK, Medline… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SPNG NEURO 1X1 10/PK… During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1 During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medline medical procedure kits, containing Medline Neuro Sponges During an internal review, Medline identified higher-than-expected endotoxin levels on a representative Medline neuro sponge product, indicating that in-market… Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: Universal… Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: LATEX FREE GENERAL… Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline or Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE… Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1 Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing Cardinal Health Webcol Large Alcohol Prep Pads. Class IIFDA’s classMay 6, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedMay 6, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains two low-pressure mercury bulbs with a… In some foreseeable use conditions, the Products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall The product is a handheld ultraviolet-C germicidal wand and contains a combination of five UV-A and UV-C LED… In some foreseeable use conditions, the products can expose nearby persons to UVC radiation at levels significantly above limits recommended by international… Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall CUSA Clarity C7000 Console, Software Version: 2.1.1.909 Software issue that renders the touch screen unresponsive. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide, and Michigan and New York named
- Medical device recall Medline Namic Guidewires: 1) GUIDEWIRE 3MMJ 0.035X260CM LT The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Namic Syringes: 1) SYR CNTRL 10ML RING W/ROT NB The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Syringes: 1) SYRINGE 12ML CONTROL W/ROTATOR The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) ANGIO CATH PACK-MARY IMMACULAT The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) SYR CNTRL 10ML RING W/ROT NB The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) ANGIOGRAPHY PACK-LF The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) CATH LAB CDS The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) MTS LEFT HEART KIT-CAROLINAS HOS The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) PICC TRAY The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) HEART TRANSPLANT BIOPSY The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) ENT PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) GENERAL LAPAROSCOPY The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) BREAST PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) NEWBORN ADMISSION The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) SYR CONTROL 8ML ROTATING The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) ARTHROGRAM TRAY The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) LABOR PACK-22025208-LF The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) GYN LAPAROSCOPY PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) HYSTEROSCOPY PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) D AND C PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) BWNBORO CRANIOTOMY PACK-LF The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Kits: 1) ARTHROSCOPY PACK The 510(k) regulatory clearances for certain Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. Class IIFDA’s classApr 29, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedApr 29, 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.”
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