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 Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PAIN PRE OP KIT DYKS1476A Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators OPEN HEART CDS983348AA CDS983348AB Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BASIN PACK-LF DYNJ42828B EYE BASIN… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE PINK PERIPHERAL… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators BLOOD CULTURE KIT 2 W/CONNECT… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators DELUXE PRE OP KIT DYKS2018 GENERAL… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators PATIENT ADMIN KIT DYKA1384B… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators LABOR CDS CDS981762B VAG DELIVERY… Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators C-SECTION PREP DYNJ32702B Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators CATARACT PREOP KIT DYKS1583A Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ORTHO ASPIRATION KIT DYKM1636A Convenience kits contain BD ChloraPrep Clear - 1mL Applicators from specific lots that were recalled by the manufacturer because they may have an open or… Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS US There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS EU There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall LUX-Dx, LUX-Dx II, LUX-Dx II+ Insertable Cardiac Monitor System, SERVER SW LAT CLARITY DS ANZ There is potential for a delay in AF Burden Alert notification affecting the server software which supports the Insertable Cardiac Monitors (ICMs). Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall 5008X Standard HD Pre-Flush Standard Blood Tubing Set Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall 5008X HD/HDF Standard Blood Tubing Set Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall 5008X HD/HDF with CLiC Blood Tubing Set Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall 5008X HD/HDF with Twister Blood Tubing Set Heightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 20 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Colorado, Florida, Georgia, Illinois, Kentucky, Louisiana, Massachusetts, Maryland, Minnesota, Missouri, North Carolina, New Hampshire, New York, Ohio, Pennsylvania, Tennessee, Texas and Virginia named
- Medical device recall Velys Enabling Tech Robotic-Assist Station Software issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 16 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and Delaware, Florida, Illinois, Kentucky, Maryland, Michigan, Minnesota, New Jersey, New Mexico, New York, Oregon, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Specific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Colorado, Florida, Georgia, Hawaii, Illinois, Indiana, Louisiana, Massachusetts, Maryland, North Carolina, New Jersey, New York, Pennsylvania, Tennessee, Texas, Virginia and Washington named
- Medical device recall GRANUFLO Dry Acid Concentrate: Product Numbers: 0FD2251-3B Complaints of blue-green discoloration in product Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall NaturaLyte, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-1251-1, 08-2251-0,… Complaints of blue-green discoloration in product Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Citrasate, Liquid Acid Concentrate for Bicarbonate Hemodialysis: Product Numbers: 08-2251-CA, 08-3251-CA,… Complaints of blue-green discoloration in product Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,GYN LAPAROSCOPY… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GYN ROBOTIC… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, LUNG TX… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,ROBOTICS DH The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, GVI OPEN HEART… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT,MAXILLOFACIAL… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ENT HARVEST The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, BLO ROBOTIC GYN The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ROBOTIC HYST The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) PBCGLVBLI The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, ASLMC… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1) KIT, CHONY ORTHO… The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. Class IIFDA’s classSep 9, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 9, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Incisive CT with software V4.5&V5.0 Potential of failing to trigger clinical scan during Bolus Tracking. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Hudson RCI, DBD-CIRCUIT,VENT,INSPIRATORY,HEATED,NEO, Medline Product Number/SKU HUD78019 (Teleflex… Neonatal and infant heated wire breathing circuits may experience sporadic failure. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Medline Product… Neonatal and infant heated wire breathing circuits may experience sporadic failure. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline breathing circuits labeled as: 1) MEDLINE HUDSON RCI, CIRCUIT, NEO, SING LIMB, HTD,COLUMN, Medline… Neonatal and infant heated wire breathing circuits may experience sporadic failure. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin and Wyoming named
- Medical device recall Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin and Wyoming named
- Medical device recall Medline medical convenience kits, labeled as: 1) NEURO CDS, Medline Kit Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin and Wyoming named
- Medical device recall Medline medical convenience kits, labeled as: 1) LAMINECTOMY PACK, Medline Kit Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 17 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Iowa, Idaho, Illinois, Indiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, New York, Ohio, Texas, Wisconsin and Wyoming named
- Medical device recall Onli 17cm Hydrophilic Urethral Intermittent Catheter, labeled as: 1) 82081 Ch08-17 Onli Hydrophilic Urethral… Hollister has identified that select lots of the catheters identified in the above table may exhibit a protrusion caused by a manufacturing defect which might… Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline medical convenience kit labeled as: TRACH TUBE KIT, Medline Kit Component labeling discrepancy Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and California named
- Medical device recall American Contract System Convenience Kit, CV B PACK The Convenience Kits contain Medline s Red Rubber Intermittent Catheters (8Fr-22 Fr) and Red Rubber Intermittent Catheter Trays. Class IIFDA’s classSep 2, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedSep 2, 2026ClassClass IIStatusOngoingWhereNationwide, and Iowa and Ohio 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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