Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 151 - 175 of 210 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.	FDA Z-1239-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 19, 2025	Details
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 used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1280-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.	FDA Z-1242-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 19, 2025	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0730; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1274-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
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 used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1284-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
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 used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1268-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
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 used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1277-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1275-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Focalyx Fusion Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, which may cause patient harm during biopsy or cause treatment/therapy delays, so firm is recommending stop use until device is verified/validated with Windows 11.	FDA Z-1243-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 23, 2025	Details
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0720; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1278-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1297-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Product Name: Lumipulse G pTau 217 Plasma Calibrators Model/Catalog Number: 81557 Software Version: Not Applicable Product Description: Lumipulse G pTau 217 Plasma Calibrators: The pTau 217 plasma concentration of a specimen is automatically calculated from the calibration curve, which is also automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G pTau 217 Plasma Calibrators: Liquid (Frozen), 1x1.5 mL (5 Concentrations) CAL 1 0 pg/mL pTau 217 Plasma Calibrator CAL 2 0.250 pg/mL pTau 217 Plasma Calibrator CAL 3 1.000 pg/mL pTau 217 Plasma 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 to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).	FDA Z-1303-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 11, 2025	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1273-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0330; Software Version: N/A Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current. Devices which did not undergo thermoforming could deform and lose performance.	FDA Z-1271-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Product Name: Lumipulse pTau 217 Plasma Controls Model/Catalog Number: 81558 Software Version: Not Applicable Product Description: Lumipulse pTau 217 Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing pTau 217 in K2EDTA plasma on the LUMIPULSE G System. It is a valuable tool to assess good laboratory practices. Two levels of control are available to compare observations with expected ranges therefore assuring consistent performance of the testing system within the clinical range. Lumipulse p 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 to FDA-cleared CSF ratio/PET imaging, due to falsely elevated positive ratio or falsely elevated indeterminate ratio results causing an incorrect classification of a patient as having amyloid pathology associated with Alzheimer s disease (positive result) and/or requiring more clinical testing of that patient (indeterminate result).	FDA Z-1304-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 11, 2025	Details
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 administration of fluids to adult, pediatric, and neonatal patients through clinically accepted routes of administration: intravenous (IV), intra-arterial (IA), subcutaneous, epidural, or irrigation of fluid spaces. The BD AlarisTM System includes the PC Unit (PCU) and one or more of the following: Pump Module, Syringe Module, end-tidal CO2 (EtCO2) Module, Auto-ID Module, patient-controlled analgesia ( 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 issue only affects the Interoperability workflow for devices with a DST invalid timestamp, impacting connectivity of the PCU to the hospital network	FDA Z-1217-2026	Medical Device	High	Feb 4, 2026 Recall: Nov 6, 2025	Details
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 Component: No Due to a manufacturing issue and electrical grounding of systems.	FDA Z-1164-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 14, 2025	Details
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 weight-based reference tool specifically designed for pediatric emergency care. Component: No Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1114-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix T; Siemens Material Number (SMN): 11574003; With Software Version VB10D-SP02 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 processed.	FDA Z-1175-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 29, 2025	Details
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 weight-based reference tool specifically designed for pediatric emergency care. Component: no Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1117-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
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 weight-based reference tool specifically designed for pediatric emergency care. Component: No Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1116-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
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 recall for A.T.S.¿ 5000TS Product Description: A.T.S 5000TS Tourniquet Systems Component: N/A 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 alternate device is located.	FDA Z-1201-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 24, 2025	Details
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 recall for A.T.S.¿ 3200TS Product Description: A.T.S 3200TS Tourniquet Systems Component: N/A 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 alternate device is located.	FDA Z-1202-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 24, 2025	Details
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 weight-based reference tool specifically designed for pediatric emergency care. Component: No Product contains potentially harmful dosing errors for Vecuronium, Flumazenil, and Ketamine.	FDA Z-1115-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 15, 2025	Details
Interventional Fluoroscopic X-Ray System: LUMINOS Q.namix R; Siemens Material Number (SMN): 11574002; With Software Version VB10D-SP02 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 processed.	FDA Z-1174-2026	Medical Device	High	Feb 4, 2026 Recall: Dec 29, 2025	Details

Showing 151 - 175 of 210 product recalls

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Medical Device Recalls Today

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