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 CARROLLTON HIP FX Convenience kit used for surgical procedures Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall ARTHROSCOPY Convenience kit used for surgical procedures Products within a Medline pack may be impacted by a packaging error in which an incomplete seal has formed on the packaging thereby creating a packaging seal… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 1 state named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Tennessee named
- Medical device recall Brand Name: Olympus Product Name: Cystoscope Outer Sheath Olympus is removing the statement of compatibility with a GreenLight Laser for BPH therapy from the Instruction for Use (IFU) due to the potential for a… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 45 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Vermont, Washington, Wisconsin, West Virginia and Wyoming named
- Medical device recall Philips Zenition 50 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Philips Zenition 70 Potential for the Mains Control Unit board fuse may blow out during system start-up or during a procedure. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Clean Catch Kit Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall Lab Kit, SKU DYLAB1018; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall UA KIT, SKU DYKM1690A; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall URINALYSIS KIT 4 Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall URINE COLLECTION KIT Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall URINE COLLECTION VHC Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall URINE KIT, SKU DYKM1845; Component No. 503581 Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall URINE KIT W/BD CUP Specimen container included in kits is labeled as sterile, but has been identified to be non-sterile. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, California, Florida, Georgia, Illinois, Kentucky, Missouri, Mississippi, Montana, Tennessee, Texas, Virginia and Washington named
- Medical device recall The IMAGEnet 6 Ophthalmic Data System is a software program that is intended for use in the collection,… The overlay of visual field test locations on a probability map, as presented in IMAGEnet 6 in the so-called “Hood Report”, is not appropriate as it can imply… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Irrigation Tubing for KARL STORZ Endomat Select UP210 Due to improper labeling of products. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 13 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Colorado, Connecticut, District of Columbia, Maryland, Michigan, Minnesota, North Carolina, New York, Ohio, Oklahoma, Tennessee, Texas and Washington named
- Medical device recall Brand Name: UroPass Ureteral Access Sheaths Product Name: Ureteral Access Sheaths Exposure of the UroPass product to Ultraviolet ( UV ) Radiation can cause brittleness of the device dilator tip, which may lead to broken dilator tips in the… Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for general… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general… There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation,… The Venclose” RF Ablation Catheters may have been manufactured with internal wiring error. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 47 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, 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 Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and West Virginia named
- Medical device recall Medtronic Recharger Kits, RS6230, RS7230, and RS5220A, containing components WR9230 and WR9220A Recharger for… The Wireless Rechargers in the kits may be unable to enter a recharging session upon first use. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word, and 18 states named PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide, and Alabama, Arizona, California, Florida, Georgia, Idaho, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania, South Carolina, Texas, Virginia and Washington named
- Medical device recall Halyard IR ABCESS DRAINAGE PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard IR BIOPSY PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard D & C PACK-CKC - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard ENT T AND A PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard OPEN HEART PACK MAIN - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard AORTA PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard GENERAL SET UP PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, TOTAL KNEE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, SHOULDER - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, CARDIAC ROBOTIC - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard ANTERIOR HIP PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, TOTAL KNEE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, TOTAL KNEE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, SPINE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard KIT, SPINE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard FOOT ANKLE PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard ABDOMINAL PROCEDURE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard BASIC PROCEDURE PACK - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard TOTAL KNEE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard CYSTO PDS - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard MINOR PDS - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard LAPAROSCOPY TRAY - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard GYN TRAY - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
- Medical device recall Halyard C SECTION BUNDLE - Medical convenience kits Sponge forceps and towel clamps associated with small loose metal flakes potentially could detach from the components. Class IIFDA’s classNov 20, 2024in FDA’s Enforcement ReportNationwideFDA’s word for where it went PublishedNov 20, 2024ClassClass IIStatusOngoingWhereNationwide
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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