Medical devices, 2024
Shortlist up to four to read them side by side.
3,394 medical device recalls FDA’s Enforcement Report published in 2024, 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 5, 2026.
3,394of 3,394 medical device recallsshown with your filters
The list
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) T&A CDS-LF It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) CYSTO CDS It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline CENTRAL CATHETER INSERTION TRA It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline DIALYSIS PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) TRAY ADD A CATH FOL UM MF 10ML It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) PLASTIC PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY XXX Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline CHEST TUBE INSERTION TRAY ADUL It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline IV TEAM PICC It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline PEDIATRIC DRAPE PK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline TUBAL LIGATION PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) UNIVERSAL DRAPE PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline AMBULATORY MINI PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) NEURO PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) L&D/OB PACK-LF It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) LITHOTOMY PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) ABDOMINAL HYSTERECTOMY TEGH-LF It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: a) OB PACK-LF It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) EYE PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline brand medical procedure convenience kits, labeled as: 1) NEW LONDON TOTAL KNEE CDS It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline EYE PACK It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Olympus Gastrointestinal Videoscope It was discovered during device performance testing that the CCD imaging sensors were programmed with the incorrect color correction data and therefore,… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall medex TranStar Single OR Set 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Single ICP Set 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex NICU Monitoring Kit Set 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TRANSTAR MONITORING KIT 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Kit w/ Stopcock1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex Arterial Kit 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Disposable Transducer 1/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Patient Mount Monitoring Kit 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar 72in Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar 60in Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar 84in Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar DPT w/Stopcock & 3cc Flush 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar DPT w/Stopcock & 30cc Flush 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar DPT w/Two Stopcocks 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Neonatal Monitoring Kit 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar KIDS KIT 19IN Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar KIDS KIT 31IN Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar KIDS KIT 34IN Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar KIDS KIT 7INCH CLOSED BLOOD SAMPLE KIT with 30cc/hr Flush Device 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar KIDS KIT 10IN Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar Stopcock w/Ext. 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar SINGLE 84IN SET WITH ANTI-SHUNT STOPCOCK 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall medex TranStar MONITORING SET W/SAMPLING PORT 10/EA Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall smiths medical SurgiVet Advisor Tech Accessories Due to a manufacturing defect, users may experience inaccurate pressure monitoring, an interruption in pressure monitoring, or an inability to zero the device… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Medtronic Percept RC Implantable Neurostimulators (INS) A limited number of Percept RC Implantable Neurostimulators (INS), Model B35300 will not be able to communicate with the A610 DBS Clinician Programmer… Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Diasol Acid Concentrate Due to labeling issue. Class IIFDA’s classOct 30, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedOct 30, 2024ClassClass IIStatusOngoingWhereNationwide, and Arizona 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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