Medical Device Recalls
RSS ↗8,689 medical device recalls from federal enforcement feeds.
Showing 2,151–2,200 of 8,689
- Class II
Medical Device Recall · December 10, 2025
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496Potential Elevated Laser Output A disconnected cable or a poorly crimped cable under mechanical bending stress can cause loss of electrical contact. At one connection on the board, the failure can drive the laser output to approximately 1,600 mW. Potential Unintended Laser Firing A disconnected, or poorly crimped cable can falsely signal a fire command during measurement cycles. At a secondary location on the board, this fault can lead to unexpected laser activation during operation. Safety logic prevents firing when the system is idle.
- Class II
Medical Device Recall · December 10, 2025
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)Using oncology information system that manages workflow may result in overtreatment if:Plan delivered with Particle Therapy IHE-RO TDW-II interface,With one field per fraction or last field partial treatment,Partial treatment occurs followed by treatment field interruptions with manually recorded partial treatment,Then treatment unit doesn't check meterset value so partial treatment delivered twice
- Class II
Medical Device Recall · December 10, 2025
Phothera 200, Phototherapy Devices indicated for use to treat diagnosed skin disorders such as, but not limited to, Psoriasis, Vitiligo, and Atopic Dermatitis (Eczema) under the direction of a physiciSome of the Calibration/Output Certificates had the outputs reversed.
- Class II
Medical Device Recall · December 10, 2025
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
SMV DSI, System, Tomography, Computed, EmissionGE HealthCare has become aware that certain Nuclear Medicine systems that are past the End of Guaranteed Service (herein referred to as Impacted Systems and listed in the Affected Product Details section of this letter) could have been transported or relocated without adequate detector support. This could result in excessive stress being applied to the detector mounting mechanisms, compromising their integrity. If this occurs, it can potentially result in a detector fall and lead to life-threatening bodily injury. There have been no reports of detector falls or injuries as a result of this potential issue. The Impacted Systems affected by this notice are those that have not been manufactured for several years. GE HealthCare has previously communicated End of Guaranteed Service for these Impacted Systems.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Monopolar Curved Scissors Instrument Product Name: da Vinci S and Si Monopolar Curved Scissors Instrument Model/Catalog Number: 420179 Software Version: N/A Product DescDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R+G pro 40; PALACOS R+G pro 80 Model/Catalog Number: 5081288; 5081289 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-basincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Grasping Retractor Instrument Product Name: da Vinci S, Si Grasping Retractor Instrument Model/Catalog Number: 420278 Software Version: NA Product Description: EndoWristDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV pro 40; PALACOS MV pro 80 Model/Catalog Number: 5150633; 5150635 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-basedincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS R pro 40; PALACOS R pro 80 Model/Catalog Number: 5081286; 5081287 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-based (increase of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Tenaculum Forceps Instrument Product Name: da Vinci S, Si Tenaculum Forceps Instrument Model/Catalog Number: 420207 Software Version: N/A Product Description: EndoWristDue to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Double Fenestrated Grasper Instrument Product Name: da Vinci S, Si Double Fenestrated Grasper Instrument Model/Catalog Number: 420189 Software Version: NA Product DescriDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Permanent Cautery Hook Instrument Product Name: da Vinci S, Si Permanent Cautery Hook Instrument Model/Catalog Number: 420183 Software Version: NA Product Description: EDue to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments
- Class II
Medical Device Recall · December 9, 2025
Heraeus Medical GmbH (Dental Division)
Brand Name: PALACOS Product Name: PALACOS MV+G pro 40; PALACOS MV+G pro 80 Model/Catalog Number: 5081290; 5081291 Software Version: N/A Product Description: Radiopaque, poly(methyl methacrylate)-bincrease of complaints regarding the breakage of the ampoules within their device systems. An extensive investigation revealed that multiple factors have an impact on the ampoule breakage. An unfortunate combination of these influence factors can lead to unbreakable ampoules. If none or not all ampoules break, the product cannot be used on the patient since no or no appropriate cement dough is formed.
- Class II
Medical Device Recall · December 9, 2025
Brand Name: da Vinci S, Si Mega Needle Driver Instrument Product Name: da Vinci S, Si Mega Needle Driver Instrument Model/Catalog Number: 420194 Software Version: NA Product Description: EndoWristDue to increased complaints for broken/frayed grip cables for reusable instruments.
- Class II
Medical Device Recall · December 8, 2025
Brand Name: HFD100 Product Name: Head Fixation Device HFD100 Model/Catalog Number: 119695-000, 119629-000, 119630-000, 113803-000, 113803-600, 113802-000, 113802-600 Software Version: Not ApplicablTorque screw may crack or separate. If used, an affected screw could lead to inadequate head stabilization, compromised surgical precision, procedural delays, requirement for alternate head fixation methods, and risk of patient injury.
- Class II
Medical Device Recall · December 8, 2025
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterolBeckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL Cholesterol reagent showed clinically significant interference due to triglyceride concentration up to 1500 mg/dL may cause a maximum positive bias of up to 28.8% in low LDL Cholesterol samples (concentration 80 mg/dL) and up to 11.02% in high LDL Cholesterol samples (concentration 160mg/dL).
- Class II
Medical Device Recall · December 8, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. AzurionNine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor, system continues to restart, AMD triple drive, C-Partition of Suite PC running out of free space, system remains in continuous restart mode after start-up, misalignment of Marker Tool Overlay, longitudinal position error.
- Class II
Medical Device Recall · December 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900MR, with Firmware version: 1.6.3Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
- Class II
Medical Device Recall · December 8, 2025
Arial 900 MHz Call Station, Model Number CSK200-900, with Firmware version: 1.6.3Securitas Healthcare has become aware of a firmware issue in the Call Stations in the Affected Lots that may cause Call Stations in the Affected Lots to (1) not transmit a low battery alert to the Arial Wireless Emergency Call System prior to battery failure, or (2) not transmit a low battery alert to the Arial Wireless Emergency Call system at least seven (7) days prior to the battery failing.
- Class II
Medical Device Recall · December 5, 2025
Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23Incorrect expiration date
- Class II
Medical Device Recall · December 5, 2025
Beaver-Visitec International, Inc.
BVI Leos Laser and Endoscopy System. Model Number: OME6000U.Manufacturing deviation in which the ferrites specified for the USB cable assembly linking the Nurse Monitor touchscreen to the System Controller were not installed as intended. The omission of the ferrites on the USB communication cable results in non-conformance to the design specifications, which require two ferrites (one at each end of the cable).
- Class II
Medical Device Recall · December 5, 2025
Siemens Medical Solutions USA, Inc
LUMINOS Lotus Max, Model 11574100 and Luminos dRF Max, Model 10762471A potential issue associated with LUMINOS Lotus Max and Luminos dRF Max systems with software version VF11 with bucky wall stand for mobile detectors and without ceiling stand .When switching quickly between organ programs (OGPs) the collimation may be incorrect.
- Class II
Medical Device Recall · December 5, 2025
Revogene C. difficile, in vitro diagnostic assay intended for use with the Revogene instrument, Catalog Number 410300The affected lots show a decline in performance over time, which may lead to false-negative results.
- Class II
Medical Device Recall · December 4, 2025
Allwell Angioplasty Pack REF: IS-30-B1/BInflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Impella 5.5 with SmartAssist¿ S2, Impella 5.5 with SmartAssist S2 Set, AU.Device packaged in incorrect outer box carton.
- Class II
Medical Device Recall · December 4, 2025
Merit Medical , Custom Manifold Kit REF: K09-13203AInflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261Inflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Class II
Medical Device Recall · December 4, 2025
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330Inflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Abre Venous Self-Expanding Stent System, Model numbers AB9G14120090 AB9G12100090 AB9G14080090 AB9G12080090 AB9U12060090 AB9U14100090 AB9U14080090 AB9U12080090 AB9U14060090 AB9G14100090 AB9G1Stents may be impacted by a Nitinol anomaly which causes a reduced stent diameter when deployed and corresponding reduced radial force. Issue may result in stent migration.
- Class II
Medical Device Recall · December 4, 2025
Allwell Inflation Device, for angiographic use REF: IS-30-AInflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted pDue to probe bags that may have a compromised or incomplete sterile pouch seal.
- Class II
Medical Device Recall · December 4, 2025
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922BInflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05TInflation device handle may detach from the syringe during procedure.
- Class II
Medical Device Recall · December 4, 2025
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.AIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label.
- Class II
Medical Device Recall · December 3, 2025
Ingenia Elition S. Product Code (REF): (1) 781357, (2) 782106, (3)782137. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter, 4F, 1) 2.5mm x120mm, 150 cm, UPM/Model No. REF H74939186251210; 2) 3.5mm x120mm, 150 cm, UPM/Model No. REF H74939186351210;Boston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon Dilatation Catheter devices due to the potential for inflation/deflation difficulty during use in the peripheral vasculature. An internal investigation found that a manufacturing process variation resulted in catheters that may not properly inflate/deflate. This was limited to Coyote OTW batches manufactured from 12Sep2025 through 13Oct2025. The processing variation has since been addressed. No other material numbers or batches are impacted by this removal.
- Class II
Medical Device Recall · December 3, 2025
Ingenia 3.0T. Product Code (REF): (1) 781342, (2) 781377. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
MR 7700. Product Code (REF): (1) 782120, (2) 782153. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Ingenia 1.5T. Product Code (REF): (1) 781341, (2) 781396. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Evolution Upgrade 1.5T. Product Codes (REF): (1) 782148, (2) 782116. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Ingenia Ambition X. Product Code (REF): (1) 781356, (2) 782109, (3)782138. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
SmartPath to dStream for 3.0T. Product Code (REF): 782145. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CTPotential for incomplete scan due to unstable connection inside of floating sensor.
- Class II
Medical Device Recall · December 3, 2025
Ingenia Elition X. Product Code (REF): (1) 781358, (2) 782107, (3) 782136. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
A71200 Vanta" Clinician Programmer Application (CP App) version 2.0.2465 and 2.0.2683, Product number A71200. Software is deployed and operated on Samsung tablets (CFN CT900).Complaints received that Vanta A71200 CP App does not function as intended during use. There is a potential for prolonged or postponed surgical procedure.
- Class II
Medical Device Recall · December 3, 2025
Ingenia 3.0T CX. Product Code (REF): 781271. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Ingenia Ambition S. Product Code (REF): 782108. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
Evolution Upgrade 3.0T. Product Code (REF): 782143. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).
- Class II
Medical Device Recall · December 3, 2025
SmartPath to dStream for XR and 3.0T. Product Code (REF): 781270. MR systems with SW version R11.1 and R12.1.The potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication System (PACS).