Reason: Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Z-2148-2025July 30, 2025Austin, TX
Medtronic, Inc.
Class IIOngoing
Medtronic SmartLink software loaded on CareLink SmartSync Device Manager, Model Number 24967A with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2...
Reason: 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-u...
Z-2128-2025July 23, 2025Mounds View, MN
NeuroSync, Inc.
Class IIOngoing
NeuroSync EYE-SYNC containing Pico Neo 2 Headsets. Each unit consists of a Pico Neo 2 headset with embedded sensors, a paired Android tablet, and proprietary software, packaged in a portable field cas...
Reason: Eye syncing issues causing the device to be inoperable. Unable to be repaired due to discontinuation of support for the Pico 2 platform, which was no longer in production or servic...
Reason: 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 use...
Reason: 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 use...
Z-2120-2025July 23, 2025Rochester, NY
Encore Medical, LP
Class IIOngoing
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 a...
Reason: 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 resu...
Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2118-2025July 23, 2025Herzliya, N/A
Baxter Healthcare Corporation
Class IOngoing
Baxter SIGMA Spectrum Infusion Pump V8, Model Number 35700BAX2
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Z-2096-2025July 23, 2025Deerfield, IL
Medtronic, Inc.
Class IIOngoing
Medtronic SmartLink Software loaded on SmartSync Patient Connector, Model Number 24967 with the following software components: 1. Azure Astra application, Software Model Number D00U003; 2. Perce...
Reason: 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-u...
Z-2127-2025July 23, 2025Mounds View, MN
Baxter Healthcare Corporation
Class IOngoing
Baxter SIGMA Spectrum Infusion Pump V6, Model Number 35700BAX
Reason: Certain Spectrum infusion pumps may have an incorrect version of software.
Reason: Due to manufacturing error, Intraosseous device built-in stabilizer may not be released properly after deployment and insertion.
Z-2119-2025July 23, 2025Herzliya, N/A
Encore Medical, LP
Class IIOngoing
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 a...
Reason: 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 resu...
Z-2126-2025July 23, 2025Austin, TX
Alcon Research LLC
Class IIOngoing
Brand Name: Alcon Laboratories, Inc. Product Name: Custom Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A Product Description: Alcon Custom Paks a...
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage...
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2083-2025July 16, 2025Irvine, CA
Alcon Research LLC
Class IIOngoing
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Combined Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A ...
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage...
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2080-2025July 16, 2025Irvine, CA
Alcon Research LLC
Class IIOngoing
Brand Name: Alcon Laboratories, Inc. Product Name: Constellation Vision System Vitrectomy Procedure Pak Model/Catalog Number: Many - See 'Attachment 1 - Affected Product List' Software Version: N/A...
Reason: Due to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area of the lidding. While the damage...
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2085-2025July 16, 2025Irvine, CA
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class IIOngoing
Varicam, Millennium VG, Millennium VG Hawkeye, Discovery VH Nuclear Medicine System
Reason: 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 mo...
Z-2098-2025July 16, 2025Tirat Carmel, N/A
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
Class IIOngoing
Infinia, Infinia Hawkeye, Infinia II, Infinia II Hawkeye 4 Nuclear Medicine system
Reason: 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 mo...
Reason: due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.
Z-2082-2025July 16, 2025Irvine, CA
Siemens Medical Solutions USA, Inc
Class IIOngoing
ARTIS is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Proc...
Reason: In very rare situations, communication between the sensor measuring dose applied to the area and the corresponding software fails. As a result of the failure, the system may incorr...