Medical device recalls
38684 federal recalls on file. Federal recalls for medical devices — surgical equipment, monitors, diagnostic tools, implants, home health devices. Sourced from the FDA.
- 2025-07-16FDA-DeviceMedtronic Navigation, Inc.-BoxboroughClass IIO-arm O2 Imaging System. Mobile X-Ray System.
A mechanical component that supports the O2 gantry to the support structure in affected devices may have been damaged during manufacture.
- 2025-07-16FDA-DeviceNeurovision Medical Products IncClass IIBrand Name: Hummingbird Product Name: Stimulated EMG Kit with Hummingbird - Model/Catalog Number: REF I-D-BMF90, 1 Single-Use Bipolar Minifork Stimulation Probe, 90mm, and 1 Green Ground Needle ; REF 1-D-BMF90-5, lot number 050925219, expiration 2028-11-30 I-D-BMF90-5 Stimulated EMG Kit with Hummingbird - Box of 5 Kits - Each Kit Includes: 1 Single-Use Bipolar Minifork Stimuation Probe, 90mm, and 1 Green Ground Needle
Product packaging contains the wrong part number and kit contents.
- 2025-07-16FDA-DeviceCanary Medical, Inc.Class IIBrand Name: Canturio¿ Smart Extension Product Name: CSE Implant Model/Catalog Number: 43-5570-030-14 Product Description: Tibial stem extension for use with Zimmer Persona¿ Personalized Knee System; 14mm diameter x 30mm height. Implantable device with integrated electronics for passive kinematic data collection. Single-use, sterile. Packaged in a sterile blister and outer shelf pack. Sold individually. Component: Yes. The Canturio¿ Smart Extension (CSE) is a tibial implant component intended
Due to labeling error. Product incorrectly labeled.
- 2025-07-16FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIVaricam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
- 2025-07-16FDA-DeviceGE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGINGClass IIInfinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Unintended radial detector motion may occur during patient setup or during patient scan if system does not have correct version of gantry software installed. Unintended detector motion may result in life-threatening injury.
- 2025-07-16FDA-DeviceSTRATASYS LTDClass IIITrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- 2025-07-16FDA-DeviceSTRATASYS LTDClass IIITrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- 2025-07-16FDA-DeviceSTRATASYS LTDClass IIITrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- 2025-07-16FDA-DeviceSTRATASYS LTDClass IIITrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- 2025-07-16FDA-DeviceSTRATASYS LTDClass IIITrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize that a resin is expired and will not prevent the user from using an expired material.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: FEM-FLEXII Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018AS Software Version: N/A Product Description: The Edwards FEMFLEXII Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII018A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016AS Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: FEM-FLEX II Product Name: Femoral Arterial Cannula Model/Catalog Number: FEMII016A Software Version: N/A Product Description: The Edwards FEMFLEXII Femoral Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI18 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceEdwards Lifesciences, LLCClass IBrand Name: Optisite Arterial Cannula Product Name: Optisite Arterial Cannula Model/Catalog Number: OPTI16 Software Version: N/A Product Description: Cardiac cannula. The Edwards OptiSite Arterial Perfusion Cannluae provides or establishes arterial perfusion in the extracorporeal circuit for d 6 hours. Component: No.
due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
- 2025-07-16FDA-DeviceGiven Imaging Ltd.Class IBravo CF capsule delivery device, designed to place and attach a pH monitoring capsule to the esophagus using endoscopic or manometric guidance, Product Number FGS-0635 (5 pack) and FGS-0636 (1 pack)
It has been determined that misapplied adhesive on the Bravo CF capsule delivery device may lead to its malfunction. Specifically, the misapplied adhesive may prevent the capsule from attaching to the patient's esophagus or detaching from the delivery device.
- 2025-07-16FDA-DeviceBaxter Healthcare CorporationClass IHillrom LikoScale component, Product Code 3156232, used with the following adapter kits for patient lifts: 1) LikoScale 200 Accessory - Product Code 3156225; 2) LikoScale 350 Accessory - Product Code 3156228; 3) LikoScale 400 Accessory - Product Code 3156226.
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- 2025-07-16FDA-DeviceBaxter Healthcare CorporationClass IHillrom Q-Link 13 component, Product Code 3156509, used with the following Mobile Patient Lifts: 1) Uno 102 EE Mobile lift - Product Code 2010004; 2) Viking L Mobile lift - Product Code 2040044; 3) Viking XL Mobile lift - Product Code 2040043; 4) Viking M Mobile lift - Product Code 2040045A; 5) Viking S Mobile Lift - Product Code 2040006; 6) Viking XS Mobile Lift - Product Code 2040007; 7) LikoLight Mobile lift - Product Code 2030001. .
The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.
- 2025-07-09FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- 2025-07-09FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- 2025-07-09FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA¿ 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- 2025-07-09FDA-DeviceSiemens Healthcare Diagnostics, Inc.Class IIADVIA¿ 120/2120/2120i SETpoint Calibrator
Products have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- 2025-07-09FDA-DeviceBecton, Dickinson and Company, BD Bio SciencesClass IIREF: 666289 , BD FACS, 7-Color Setup Beads, 25 Runs, CE, IVD. Used in flow cytometry for fluorescence compensation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- 2025-07-09FDA-DeviceBecton, Dickinson and Company, BD Bio SciencesClass IIREF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx Only, IVD. Used in flow cytometry for fluorescence compensation.
Due to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry instrument prior to analyzing samples.
- 2025-07-09FDA-DeviceGeneoscopy, Inc.Class IIColoSense Test Kit, Part No. 80-001, component of ColoSense test
Multiple plate failures documented as a result of the Low Positive Template Control being too high and out of range using the affected lot of ColoSense Test Kit.
- 2025-07-09FDA-DeviceC.R. Bard IncClass IIREF: 123400,Bard Urologist's Tray, For the Obstructed Urethra
Cather packaging may contain the incorrect French size.
- 2025-07-09FDA-DeviceC.R. Bard IncClass IIBD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316
Cather packaging may contain the incorrect French size.
- 2025-07-09FDA-DeviceC.R. Bard IncClass IIBD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120
Cather packaging may contain the incorrect French size.
- 2025-07-09FDA-DeviceOrtho-Clinical Diagnostics, Inc.Class IIVITROS Chemistry Products OP Reagent Gen 15. Model Number: 680 1997. The VITROS OP Reagent is a dual-chambered package containing ready-to-use liquid reagents that are used to detect opiates in urine. One sales unit contains 6 Microtip packs of reagent. Each pack has 50 OP tests.
Lots from Generation (GEN) 15 of VITROS Chemistry Products OP Reagent may generate lower than expected quality control (QC) results. If the customer is unable to get passing quality control results, then the customer would be unable to run the OP-LO protocol leading to a potential delay in patient results.
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