Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0320; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Z-1239-2026February 11, 2026Malvern, PA
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse G pTau 217 Plasma Immunoreaction Cartridges Model/Catalog Number: 81550 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Immunoreaction Cart...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1302-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC412Q-0215; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1282-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0730; Software Version: N/A Product Description: These instruments have been designed to be u...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1277-2026February 11, 2026Center Valley, PA
Beckman Coulter, Inc.
Class IIOngoing
CellMek SPS Sample Preparation System, REF: C44603, with software
Reason: Sample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or touching tube bottoms, which coul...
Z-1235-2026February 11, 2026Miami, FL
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators Model/Catalog Number: 235454 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: ...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1306-2026February 11, 2026Malvern, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0730; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1279-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A Product Description: These instruments have been designed to be u...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1268-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number:KD-VC433Q-0730; Software Version: N/A Product Description: These instruments have been designed to be use...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Z-1284-2026February 11, 2026Center Valley, PA
Olympus Corporation of the Americas
Class IIOngoing
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC433Q-0720; Software Version: N/A Product Description: These instruments have been designed to be us...
Reason: Devices which did not undergo thermoforming could deform and lose performance.
Reason: To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.
Z-1241-2026February 11, 2026Malvern, PA
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio Model/Catalog Number: CL0073 Software Version: Not Applicable Product Description: Lumipulse G pTau217/¿-Amyloid 1-42 Plasma Ratio is ...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1301-2026February 11, 2026Malvern, PA
Fujirebio Diagnostics, Inc.
Class IIOngoing
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control prod...
Reason: Customers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low specificity when compared back ...
Z-1307-2026February 11, 2026Malvern, PA
SunMed Holdings, LLC
Class IOngoing
Brand Name: Broselow Product Name: Broselow Domestic Complete ALS Organizer Model/Catalog Number: 7730ALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and w...
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1116-2026February 4, 2026Grand Rapids, MI
Zimmer Surgical Inc
Class IIOngoing
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 5000TS Tourniquet Systems Model/Catalog Number: 60500010100 Software Version: Software version v2.04 or prior are within scope of the re...
Reason: Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternat...
Z-1201-2026February 4, 2026Dover, OH
SunMed Holdings, LLC
Class IOngoing
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700REA Software Version: Not Applicable Product Description: The Broselow Tape is a length- and ...
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1114-2026February 4, 2026Grand Rapids, MI
SunMed Holdings, LLC
Class IOngoing
Brand Name: Broselow Product Name: BROSELOW" FILLED BROSELOW ORGANIZER Model/Catalog Number: 7730IALS Software Version: Not Applicable Product Description: The Broselow Tape is a length- and weigh...
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Z-1117-2026February 4, 2026Grand Rapids, MI
Zimmer Surgical Inc
Class IIOngoing
Brand Name: Zimmer Tourniquet Systems Product Name: A.T.S.¿ 3200TS Tourniquet Systems Model/Catalog Number: 60320010100 Software Version: Software version v2.06 or prior are within scope of the re...
Reason: Device user interface (screen) may freeze or become unresponsive to touch when operating in certain non-English language settings. Issue may cause delay or extension while alternat...
Z-1202-2026February 4, 2026Dover, OH
Siemens Medical Solutions USA, Inc
Class IIOngoing
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02
Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr...
Z-1174-2026February 4, 2026Malvern, PA
Siemens Medical Solutions USA, Inc
Class IIOngoing
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02
Reason: Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr...
Z-1175-2026February 4, 2026Malvern, PA
CareFusion 303, Inc.
Class IIOngoing
BD Alaris" Pump Module model 8100 UDI-DI code: 10885403810046 The BD AlarisTM System with Guardrails" Suite MX is a modular infusion pump and monitoring system for the continuous or intermittent a...
Reason: Due to a number of modules flashed with a date and time associated with the daylight savings time (DST) adjustment that may cause connectivity issue with hospital networks. This is...
Z-1217-2026February 4, 2026San Diego, CA
Elekta, Inc.
Class IIOngoing
Brand Name: Elekta Medical Linear Accelerator Product Name: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD Software Version: N/A Product Description: Digital Linear Accelerator Componen...
Reason: Due to a manufacturing issue and electrical grounding of systems.
Z-1164-2026February 4, 2026Atlanta, GA
SunMed Holdings, LLC
Class IOngoing
Brand Name: Broselow Product Name: Broselow Pediatric Emergency Rainbow Tape Model/Catalog Number: 7700RE Software Version: Not Applicable Product Description: The Broselow Tape is a length- and w...
Reason: Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.
Reason: Potential for the invalidation for calculated radiation dose does not work as intended for certain Regions of Interest (ROIs). This issue occurs for some ROI(s) which have no conto...