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 GE Healthcare Revolution Maxima Select GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package,… GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for… GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution… GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD GE HealthCare has become aware of a potential issue on certain Discovery, Optima, Revolution series CT systems, and certain operator console upgrades that can… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Hollister CalciCare Calcium Alginate Dressing Due to defects on primary packaging pouch that compromise the device’s ability to maintain a sterile barrier. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Texas and Virginia named
- Medical device recall McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic… Due to defects on primary packaging pouch that compromise the device’s ability to maintain a sterile barrier. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Texas and Virginia named
- Medical device recall MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE Due to defects on primary packaging pouch that compromise the device’s ability to maintain a sterile barrier. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 3 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Illinois, Texas and Virginia named
- Medical device recall EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 High-level disinfection (“HLD”) with Acecide-C disinfectant in the Olympus OER-Pro Automated Endoscope Reprocessor (“AER”) has been removed as a compatible… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 44 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) - In-Vitro BD BBL Sensi Disc Ampicillin 2 ¿g (AM-2) are used for… BD identified through potency testing as part of a stability test request to monitor Ampicillin AM-2 due to decrease in potency results of 65% at 18 months,… Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 8 states named PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide, and California, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Nebraska and Pennsylvania named
- Medical device recall MEDLINE convenience kits labeled as: 1) TRACH TOTE Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE medical convenience kits labeled as: 1) ACETABULAR PACK-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) ANGIO PACK #2, REFDYNJ39185D Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MAJOR VASCULAR-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) CVL PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) BREAST BIOPSY PACK-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) ORAL SURGERY PK RFID Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) ZALE HEAD & NECK CDS Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 2) ABDOMINAL LAPAROSCOPY Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GENERAL ENDOSCOPY PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: PORT INSERTION PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MAMMOPLASTY-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Refer to RES or lead review memo for complete list of affected reference/catalog numbers Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: COLON WOUND CLOSURE PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) BURN Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) CLEAN CLOSING PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: L&D MINOR PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) BASIC NEURO PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) VAGINAL Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) LITHOTOMY/PELVISCOPY PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) GYN LAPAROSCOPY-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) CIRCUMCISION PACK Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MAJOR LITHOTOMY CDS-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) TOT/ GYN LITHOTOMY CDS Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81 Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall MEDLINE convenience kits labeled as: 1) ORTHO LAMINECTOMY-LF Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker. Class IIFDA’s classDec 11, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 11, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall BioZorb Marker Firm received reports of adverse events/complications that include serious injuries, such as pain, infection, rash, device migration, device erosion, seroma,… FDA Class I, its most serious class Class IFDA’s class (needs attention)Dec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedDec 4, 2024ClassClass IStatusOngoingWhereNationwide
- Medical device recall Defibtech DDP-100 Adult Defibrillation Pads For use with AED Models: Lifeline and Lifeline Auto (DDU-1:XX… Within the Irish Market, a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the authorized… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Defibtech DDP-200P: Pediatric Defibrillation Pads 0 For use with AED Models: Lifeline and Lifeline Auto… Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Defibtech DDP-2001: Adult Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro,… Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall Defibtech DDP-2002: Pediatric Defibrillation Pads For use with AED Models: Lifeline View Auto, lifeline Pro,… Within the Irish Market, that a Field Safety Notice is being issued due to a select number of authorized labelled Defibtech AED Pads, which have had the… Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNot namedno state, in where it went PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNo state named
- Medical device recall V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M” V.A.C.¿ Ulta Negative Pressure Wound Therapy… Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 51 states named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Northern Mariana Islands, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode Island, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall MEDLINE NEXUS 19/20G CATH CONNECTOR, Medline The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) COMBINED SPINAL AND EPIDURAL The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) 20G EPI CATH SINGLE STERILE The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands named
- Medical device recall MEDLINE procedure kits labeled as follows: 1) ECHOSTIM BLOCK SET The connectors may not allow catheters to be inserted as intended if the connector is not in the fully open position. Class IIFDA’s classDec 4, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedDec 4, 2024ClassClass IIStatusOngoingWhereNationwide, and US Virgin Islands 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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