Medical Device Recalls

5,000 FDA enforcement actions for medical devices and equipment. Showing the 100 most recent.

Class II: Risk FUJIFILM Healthcare Americas Corporation 01/09/2026

It was found that the contacts of the electromagnetic contactors used inside the cabinet of the X-ray high-voltage generator were welded, and the current might continue to be supplied to the power supply circuit even if the power of the device is cut off. As a result, it cannot be denied that the circuit in question overheats and damages the surrounding parts. It may also cause smoke.
Class II: Risk Maquet Cardiopulmonary Gmbh 01/09/2026

Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk Olympus Corporation of the Americas 01/07/2026

Devices which did not undergo thermoforming could deform and lose performance.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk VANTIVE US HEALTHCARE LLC 01/06/2026

There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.
Class II: Risk Biomerieux Inc 01/05/2026

Potential risk of Quality Control failures and/or false resistant antibiotic results when testing isolates of Enterobacterales/Enterobacteriaceae species and/or Pseudomonas aeruginosa with the identified antibiotic formulations. Issue may lead to QC failure or false resistant results.
Class II: Risk Encore Medical, LP 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk Encore Medical, LP 01/05/2026

942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.
Class II: Risk Miach Orthopaedics 12/31/2025

Incorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will also be incorrect.
Class II: Risk Siemens Medical Solutions USA, Inc 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk Cerapedics, Inc. 12/29/2025

Incorrect expiration date
Class II: Risk Siemens Medical Solutions USA, Inc 12/29/2025

Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be processed.
Class II: Risk Cardinal Health 200, LLC 12/26/2025

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Class II: Risk GOLD STAR DISTRIBUTION INC 12/26/2025

Potential exposure of rodents and rodent activity in the distribution center.
Class II: Risk GOLD STAR DISTRIBUTION INC 12/26/2025

Potential exposure of rodents and rodent activity in the distribution center.
Class II: Risk GOLD STAR DISTRIBUTION INC 12/26/2025

Potential exposure of rodents and rodent activity in the distribution center.
Class II: Risk GOLD STAR DISTRIBUTION INC 12/26/2025

Potential exposure of rodents and rodent activity in the distribution center.
Class II: Risk GOLD STAR DISTRIBUTION INC 12/26/2025

Potential exposure of rodents and rodent activity in the distribution center.
Class II: Risk Zimmer Surgical Inc 12/24/2025

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Class II: Risk GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING 12/24/2025

There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
Class II: Risk Zimmer Surgical Inc 12/24/2025

Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternate device is located.
Class II: Risk Focalyx Technologies, LLC. 12/23/2025

Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.
Class II: Risk Beckman Coulter, Inc. 12/23/2025

Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
Class II: Risk LSL Healthcare Inc. 12/22/2025

BD ChloraPrep Triple Swabsticks, a component within the kits, exhibit an open seal on the packaging of the applicators.
Class II: Risk Philips North America 12/22/2025

A recent software (SW) patch modifies Mobile Event Notification filter settings without providing any indication to the user when upgrading the system.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II: Risk ICU Medical, Inc. 12/19/2025

Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
Class II: Risk Tyber Medical 12/19/2025

The supplier manufactured anatomical left plates with an incorrect thread orientation.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II: Risk Siemens Medical Solutions USA, Inc 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk Siemens Medical Solutions USA, Inc 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II: Risk ICU Medical Inc. 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

There is a potential for formation of ice occurring in the venting system of the superconducting magnet of the MRI systems. if a quench occurs in this condition, helium gas may not be able to escape via the designed vent paths, and the pressure in the helium vessel may rise. This pressure build-up could eventually rupture the helium vessel, causing helium gas to be released into the MR scanning room.
Class II: Risk Tornier, Inc 12/19/2025

A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
Class II: Risk MicroPort Orthopedics Inc. 12/19/2025

Due to products not having FDA Premarket authorization to be distributed within the United States.
Class II: Risk ICU Medical Inc. 12/19/2025

Affected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may also lead to blood leakage during sampling of arterial blood or leakage during fluid delivery.
Class II: Risk Siemens Medical Solutions USA, Inc 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class I: Dangerous Boston Scientific Corporation 12/19/2025

Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.
Class II: Risk Tyber Medical 12/19/2025

The supplier manufactured anatomical left plates with an incorrect thread orientation.
Class II: Risk Canon Medical System, USA, INC. 12/19/2025

It has been discovered that there is a possibility that the fixing screws of the ceiling movement gear in the ceiling suspended arm that are part of the X-ray interventional systems may become loose. As a result, ceiling lateral movement may no longer be possible, abnormal noise may be generated from the suspension system and a sensor error may be displayed
Class II: Risk Siemens Medical Solutions USA, Inc 12/19/2025

To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Class II: Risk Community Products, LLC 12/18/2025

Potential for fraying on the body support strap.
Class II: Risk Community Products, LLC 12/18/2025

Potential for fraying on the body support strap.
Class II: Risk Community Products, LLC 12/18/2025

Potential for fraying on the body support strap.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Aju Pharm Co., Ltd. 12/17/2025

Reports of device failure, including anchor breakage, anchor bending, anchor pull out, suture breakage, and secondary packaging breakage.
Class II: Risk Vortex Surgical Inc. 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class II: Risk Medline Industries, LP 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk Medline Industries, LP 12/16/2025

Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
Class II: Risk Vortex Surgical Inc. 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.
Class II: Risk Vortex Surgical Inc. 12/16/2025

XXX
Class II: Risk Vortex Surgical Inc. 12/16/2025

There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.