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 Surgify Halo, 5.4 mm, Long Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Louisiana, Massachusetts, Minnesota and New York named
- Medical device recall Surgify Halo, 5.4 mm, Long Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 7 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Florida, Indiana, Louisiana, Massachusetts, Minnesota and New York named
- Medical device recall Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail… Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Octopus Evolution Tissue Stabilizer During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Octopus Evolution AS Tissue Stabilizer During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Octopus 4 Tissue Stabilizer During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Philips Telemetry Monitor 5500 1.4 GHz Potential for device reset to default “NEW_DEVICE” state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 10 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Arizona, California, Colorado, Indiana, Massachusetts, Michigan, Minnesota, Pennsylvania, South Dakota and Tennessee named
- Medical device recall Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device There is the potential for leakage along the drug pathway from the pump through the end of the catheter. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2026ClassClass IIStatusCompletedWhereNationwide, and Ohio named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 34 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Mississippi, Montana, Nebraska, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, Tennessee, Texas, Virginia, Wisconsin and Wyoming named
- Medical device recall Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP Potential for thrombus formation during prolonged use of the introducer. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Illinois, Minnesota, New Jersey, New York and Virginia named
- Medical device recall Abiomed 14 Fr x 25 cm Low Profile Introducer Kit for Impella CP Potential for thrombus formation during prolonged use of the introducer. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Illinois, Minnesota, New Jersey, New York and Virginia named
- Medical device recall Abiomed Impella CP Set with SmartAssist Potential for thrombus formation during prolonged use of the introducer. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Illinois, Minnesota, New Jersey, New York and Virginia named
- Medical device recall Abiomed Impella CP Set with SmartAssist Potential for thrombus formation during prolonged use of the introducer. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 6 states named PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide, and Florida, Illinois, Minnesota, New Jersey, New York and Virginia named
- Medical device recall Giraffe Stand-alone Infant Resuscitation System Blender knob shaft can loosen, which can affect the delivered oxygen concentration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Giraffe Warmer with Integrated Resuscitation System (iRes), Panda Warmer with Integrated Resuscitation System… Blender knob shaft can loosen, which can affect the delivered oxygen concentration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Panda Freestanding Warmer, Infant Radiant Warmer Product Identifiers: 2063568-001 Impacted only if service… Blender knob shaft can loosen, which can affect the delivered oxygen concentration. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNot namedno state, in where it went PublishedJun 24, 2026ClassClass IStatusOngoingWhereNo state named
- Medical device recall Automated Impella Controller (AIC), for use with left heart support blood pump Potential software error in the Automated Impella Controller (“AIC” ) when used in conjunction with left ventricular Impella devices. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall PARACENTESIS KIT Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: ACCESS TRAY/ASK-04001-SUH-S Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: BIOPSY SYSTEM COMPREHENSIVE KIT/ASK-09458-AH, ASK-09458-COC, ASK-09458-EUH, ASK-09458-SD,… Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: PACING PSI KIT: 6 FR/AI-06210-KS, PACING PSI KIT: 5 FR 2-L/AI-07155-KS, PACING PSI KIT: 5 FR… Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: AGBA PICC G4 Stylet: 3L 6FR x 55CM BP/DLX-45563-VPSB Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: RA CATH KIT: 20 GA X 1 3/4 IN/TJ-04020-1 Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: PSI KIT: 7 FR X 4IN ANTIMICROBIAL/ASK-09701-UMH Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: PI AGBA PICC KIT: 3L 6 FR X 40 CM W/VPS/ASK-44063-NS AGBA PICC/DELTA: 2L 5.5 FR X 50… Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: EPIDURAL CATHETER KIT: 19 GA X 90 CM/ASK-05502-VM1 Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: HEMODIALYSIS KIT: 2L 14 FR X 20 CM AGB CDC-25142-X1A Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: HEMODIALYSIS KIT: 2-LUMEN 8 FR X 11 CM/AK-11802-F Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: AHDC KIT: 3-L 12 FR X 16 CM/AK-12123-PCDC Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: PI CVC KIT: 3L 7 FR X 16 CM AGB+/ASK-42703-PNHS2 Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: CVC/PSI KIT: 2 LUMEN 8 FR X 6 IN/ASK-42802-PLH Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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 Description/REF: ARTERIAL LINE KIT: SL 20 GA X 5 IN/ASK-04510-MM6 RA CATH KIT: 20 GA X 1-3/4IN/NA-04020-X1ASP… Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. FDA Class I, its most serious class Class IFDA’s class (needs attention)Jun 24, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 52 states named PublishedJun 24, 2026ClassClass IStatusOngoingWhereNationwide, 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
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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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