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 CK000980A PowerMidline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236150 P4254108 PowerMidline Catheter 4… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CK000525B PowerPICC Provena SOLO Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741236129 CK000883 PowerPICC… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 7617408 Groshong NXT ClearVue Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741035258 The Groshong¿ NXT PICC… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 1174108 PowerPICC Catheter 4 Fr Single-Lumen UDI-DI Code: 00801741154935 1295108 PowerPICC SOLO Catheter 5 Fr… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall CK000880 Provena Midline Catheter 4 Fr Dual-Lumen UDI-DI Code: 00801741188770 S4153108BDP Provena Midline… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall 4380 ECONOMY SOFT TISSUE BIOPSY TRAY UDI-DI Code: 0110885403108563 4382A SOFT TISSUE BIOPSY TRAY UDI-DI Code:… Due to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled by… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, 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, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Solar GI System (Water Perfusion) Under extended clinical use conditions (e.g., long duration studies), moisture generated within the pneumatic circuit may accumulate inside the system’s… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Radius VSM ECG pre-connected Set Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall Radius VSM Disposable NIBP Cuff Two devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger alarms on… Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, and California, Massachusetts, Maryland, Minnesota, North Carolina, New York, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah and Virginia named
- Medical device recall GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Due to catheter separation Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 41 states named PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, North Dakota, Nebraska, New Jersey, New Mexico, New York, Ohio, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington and Wisconsin named
- Medical device recall Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Dual Hose with CPC… Potential sterility breach in sealing area of sterile pouch. Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems Single Hose with CPC… Potential sterility breach in sealing area of sterile pouch. Class IIFDA’s classJul 8, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 8, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DYNJ905503F The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) OPEN HEART CDS The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DRAWER 6 CENTRAL LINE INSERTIO The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Medline Convenience Kits: 1) DRAWER 6A ADULT CENTRAL LINE The Medline Convenience Kits contain Arrow Kits and Sets that include Lidocaine Hydrochloride Injection, USP and Bupivacaine Hydrochloride in Dextrose… FDA Class I, its most serious class Class IFDA’s class (needs attention)Jul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IStatusOngoingWhereNationwide
- Medical device recall Da Vinci ASSY, PSS, SP1098 Operative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake pin would… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 38 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Philips Avalon Fetal Monitor, FM20 Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Avalon Fetal Monitor, FM 30 Monitor has incorrect assembly of the speaker connector which can cause device cables to be pulled out of the housing and increase the risk of intermittent or… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall TMJ Bilateral Implants Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall VOCSN+Pro package Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Utah named
- Medical device recall Multi-Snare Set: 5 mm x 125 cm A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 2 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Maryland and New York named
- Medical device recall Off-Axis Comprehensive Shoulder System Small, Augment, Off-Axis, Reamer Guide Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Off-Axis Comprehensive Shoulder System, Large, Augment, Off-Axis, Reamer Guide Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Off-Axis Alliance Glenoid, Left, 4-Peg, Augment, Reamer Guide Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Off-Axis Alliance Glenoid, Right, 4-Peg, Augment, Reamer Guide Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Acumed Hexalob Screw various sizes Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 25 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Arkansas, California, Colorado, Connecticut, Florida, Georgia, Illinois, Kansas, Kentucky, Louisiana, Massachusetts, Mississippi, North Carolina, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Washington and Wisconsin named
- Medical device recall INZONE DETACHMENT SYSTEM Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and… Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 50 states named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Delaware, Florida, Georgia, Guam, 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, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin and West Virginia named
- Medical device recall GE Healthcare AW Server 3.2 ext.6.5 GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Thuvera Laser Console Software anomaly that causes a false display of error code 5018. Class IIFDA’s classJul 1, 2026in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedJul 1, 2026ClassClass IIStatusOngoingWhereNationwide, and Massachusetts named
- Medical device recall Surgify Halo, 3.0 mm, Extendable 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, 3.0 mm, Short 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, 3.0 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, 4.0 mm, Extendable 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, 4.0 mm, Extendable 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, 4.0 mm, Short 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, 4.0 mm, Short 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, 4.0 mm, Short 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, 40 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, Extendable 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, Extendable 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, Short 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, Short 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, Medium 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, Medium 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 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
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.”
Your shortlist0 of 4
Add one more to compare.