Medical Device Recalls
RSS ↗7,959 medical device recalls from federal enforcement feeds.
Showing 3,051–3,100 of 7,959
- Class II
Medical Device Recall · June 10, 2025
RADPRO MOBILE, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85-32-63-55 TORFLEX 8.5F 63CM 55DEG Used for the percutaneous introduction of various types of cardioPotential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
BostonSight PROSE Lens.Select orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-Batt; 40KW ANALOG, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
BostonSight SCLERAL LensSelect orders of lenses were manufactured with errors impacting sagittal height, haptics, or both.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 70C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KW-FX.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart. Product ID VXW0002 Device approved and commercialized in Japan only.Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potential punctures may go undetected in clinical settings due to small size and variable location.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW.005, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.889, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Ortho-Clinical Diagnostics, Inc.
Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performance Verifier II Model/Catalog Number: 8231474 Software Version: N/A Product Description: VITROS Chemistry ProdQuality control (QC) drift when certain lots of Performance Verifiers (PVs) are used with certain lots of cholinesterase enzyme (CHE) slides. This drift occurs when the PVs are used 2-7 days after reconstitution; however, the label stability claims for the PV fluids is 7 days following reconstitution. This may lead to inaccurate QC results. The use of the PVs when the QC results are outside of the customer s established ranges could result in delayed results for patients due to the need to repeat QC testing or reconstitute new PV fluids and repeat testing. It could also result in erroneous patient results (small positive bias).
- Class II
Medical Device Recall · June 10, 2025
SM_40HF_BDC, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWMOBILE3.899, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 80C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number 40KWFXPLUS.002, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Sedecal Easy Moving Plus Model Number SM-50HF-B-D-C; 50KW 50G, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 10, 2025
Model Number SM-40HF-B-D-C; 40KW 55C, Mobile X-ray systemSedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the instructions in the manual, clearly outlining the possible consequences of improper cleaning.
- Class II
Medical Device Recall · June 6, 2025
Boston Scientific Neuromodulation Corporation
Superion IDS Kit Superion Indirect Decompression System 8MM, VF Implant 101-9808 00884662000529 Superion Indirect Decompression System 10MM, VF Implant 101-9810 00884662000536 Superion IndiAs a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected performance levels. Issues include breakage of the instruments and implant/device.
- Class III
Medical Device Recall · June 6, 2025
Akreos, SKU: AO60P0300. Akreos intraocular lensesAn off-power error was identified, which resulted in a diopter of 16, rather than the intended 3 diopter. Implantation of affected intraocular lens could result in functional visual impairment or reduction in visual acuity which could result in the need for optical or surgical correction.
- Class II
Medical Device Recall · June 5, 2025
Custom Tubing Kit: REF: K04-00417, K04-00963, K04-01029High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000908 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intraosseous accesDue to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
- Class II
Medical Device Recall · June 5, 2025
Custom Waste Management Kit: REF: K10-00353K, K10-01603C, K10-01694Q, K10-05159B, K10-05743, K10-05825APHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 105000603 Software Version: N/A Product Description: NIO devices are a spring-based, automatic intra-osseous accDue to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
- Class II
Medical Device Recall · June 5, 2025
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275BHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class II
Medical Device Recall · June 5, 2025
High Pressure Tubing: REF: 502211002, HP9720E/C, HP9721E/CHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.
- Class III
Medical Device Recall · June 4, 2025
Zvu Anorectal Manometry Procedure Kit, REF: HRAM-PROC-10Anorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the expiration date. All inner labels on kit components display the correct expiration date.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 120/2120/2120i SETpoint CalibratorProducts have the incorrect platelet (PLT) value assignments for the ADVIA 120/2120/2120i Hematology Systems.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 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.
- Class II
Medical Device Recall · June 4, 2025
Siemens Medical Solutions USA, Inc
UROSKOP Omnia. Model Number: 10094910A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Class II
Medical Device Recall · June 4, 2025
Siemens Medical Solutions USA, Inc
UROSKOP Omnia Max. Model Number: 10762473A resistor in the frequency inverter may strongly overheat potentially igniting the plastic housing of the frequency inverter on fire.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 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.
- Class III
Medical Device Recall · June 4, 2025
Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description: T4 Total ELISAAn incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the standards and control solutions in the kit by 2 months (i.e., 2026-03-31 instead of 2026-01-31). The expiration dates on the bottle labels were correct (i.e., 2026-01-31).
- Class II
Medical Device Recall · June 4, 2025
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
Azurion 7 M20. Fluoroscopic X-Ray System.Potential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose.
- Class II
Medical Device Recall · June 4, 2025
Siemens Healthcare Diagnostics, Inc.
ADVIA¿ 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.
- Class II
Medical Device Recall · June 3, 2025
Becton, Dickinson and Company, BD Bio Sciences
REF: 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.
- Class I
Medical Device Recall · June 3, 2025
Hamilton C6 REF 160021 (ESM Board PN 10144626 UDI-DI code: 76300028PN160021ZW Hamilton C6 is a ventilator intended to provide positive pressure ventilatory support to adults and pediatrics and optA mechanical defect on a printed circuit board (PCB) as a result of PCB separating process. This defect might cause the ventilator to either fail at startup (no patient involvement) or during the use of the device enter ambient state, resulting in an interruption of ventilation.
- Class II
Medical Device Recall · June 3, 2025
REF: 123400,Bard Urologist's Tray, For the Obstructed UrethraCather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
BD Heyman Follower Coude Tip for following sizes: 12Fr - REF:021312 14Fr - REF:021314, 16Fr - REF: 021316Cather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve, REF: SCXT3-5-2000; SwabCap, 200-ct. Box, REF: SCXT3-2000Due to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container, which may result in isopropyl alcohol evaporation from the sponge, which may result in inadequate disinfection.
- Class I
Medical Device Recall · June 3, 2025
Bravo 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.
- Class II
Medical Device Recall · June 3, 2025
BD Heyman Follower Straight Tip for following sizes: 10Fr - REF:21110, 12Fr - REF:21112, 14Fr - REF: 21114, 20Fr - REF: 21120Cather packaging may contain the incorrect French size.
- Class II
Medical Device Recall · June 3, 2025
Becton, Dickinson and Company, BD Bio Sciences
REF: 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.
- Class II
Medical Device Recall · June 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711 Software Version: NA Product Description: Enovis" knee devices aDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
- Class II
Medical Device Recall · June 2, 2025
Medshape Universal Joints, REF: DNE-9000-UJBone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
- Class II
Medical Device Recall · June 2, 2025
Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 10MM, VE Model/Catalog Number: 341-10-711 Software Version: NA Product Description: Enovis" knee devices aDue to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.