Class IIOngoingZ-2117-2025
DIGIMED CO., LTD recalls Portable X-ray system
Some DIOX-602 units currently in use within the United States do not meet the minimum SSD requirement of 18 cm.
DIGIMED CO., LTDJul 30, 2025
2025 device recalls
Drawn from openFDA device enforcement reports. Filter by severity, status, state, year, or manufacturer.
Showing 1,489–1,500 of 2,908 recalls
Class IIOngoingZ-2128-2025
Medtronic, Inc. recalls Medtronic SmartLink software loaded on CareLink SmartSync Device Manager
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a Sma…
Medtronic, Inc.MNJul 23, 2025
Class IIOngoingZ-2127-2025
Medtronic, Inc. recalls Medtronic SmartLink Software loaded on SmartSync Patient Connector
A software update for Medtronic CareLink SmartSync Device Manager (SmartSync) is now available. The update eliminates the potential display of an erroneous electrical reset (pop-up) message upon interrogation with a Sma…
Medtronic, Inc.MNJul 23, 2025
Class IIOngoingZ-2126-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS
Due 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.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Packaging change control
Encore Medical, LPTXJul 23, 2025
Class IIOngoingZ-2125-2025
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS
Due 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.
- Polymer/Metal/Polymer Cemented Semi-Constrained Patellofemorotibial Knee Prosthesis
- Packaging change control
Encore Medical, LPTXJul 23, 2025
Class IIOngoingZ-2124-2025
Microbiologics Inc recalls KWIK-STIK and LYFO DISK
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
Microbiologics IncMNJul 23, 2025
Class IIOngoingZ-2123-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides (Japan)
Quality 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;…
Ortho-Clinical Diagnos…NYJul 23, 2025
Class IIOngoingZ-2122-2025
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products CHE Slides
Quality 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;…
Ortho-Clinical Diagnos…NYJul 23, 2025
Class IIOngoingZ-2121-2025
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performa…
Quality 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;…
Ortho-Clinical Diagnos…NYJul 23, 2025
Class IIOngoingZ-2120-2025
Ortho-Clinical Diagnostics, Inc. recalls Brand Name: VITROS Chemistry Products Product Name: VITROS Chemistry Products Performa…
Quality 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;…
Ortho-Clinical Diagnos…NYJul 23, 2025
Class IIOngoingZ-2119-2025
Waismed Ltd. recalls Brand Name: NIO+ Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 10…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd.Jul 23, 2025
Class IIOngoingZ-2118-2025
Waismed Ltd. recalls Brand Name: NIO-A Product Name: NIO Intraosseous Device Adult Model/Catalog Number: 1…
Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Waismed Ltd.Jul 23, 2025