Medical Device Recalls | FDA Device Safety Alerts And Recall Notices

Medical Device Recall Alerts List

Showing 1,401 - 1,425 of 1,678 matching product recalls.

Product Recall	Source	Type	Risk	Date	Action
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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-1276-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Vortex Surgical 25GA I.D.D. Internal Delivery Device, VS0250.25 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.	FDA Z-1250-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 16, 2025	Details
S. Typhi/Para Typhi A Antigen Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.	FDA Z-1261-2026	Medical Device	High	Feb 11, 2026 Recall: Nov 22, 2025	Details
MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years with Type 1 diabetes, whose total daily dose of insulin is 8 units per day or more. The MiniMed 780G system is intended for continuous delivery of basal insulin at selectable rates, and the administration of insulin boluses at selectable amounts for the management of type 1 diabetes mellitus in persons seven years of age and older requiring insulin. The system is also intended to continuously monitor glucose values in the fluid un A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.	FDA Z-1238-2026	Medical Device	High	Feb 11, 2026 Recall: Nov 2, 2025	Details
Oertli 1. 23G Laser Probe OS4 Flex-Tip VK401113 2. 23G Laser Probe OS4 Illuminated Flex-Tip VK401213 3. 23G Laser Probe OS4 Intuitive Exendable VK401323 4. 25G Laser Probe OS4 Flex-Tip VK401115 5. 25G Laser Probe OS4 Illuminated Flex-Tip VK401215 6. 25G Laser Probe OS4 Intuitive Exendable VK401325 7. 27G Laser Probe OS4 Intuitive Exendable VK401327 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.	FDA Z-1246-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 16, 2025	Details
Product Name: Lumipulse ¿-Amyloid Plasma Controls Model/Catalog Number: 81559 Software Version: Not Applicable Product Description: Lumipulse ¿-Amyloid Plasma Controls: This quality control product can be used as an objective judgement of the laboratory s procedures and personnel techniques when analyzing ¿-amyloid1-42 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. Lumi 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-1307-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 11, 2025	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3020 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-1295-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
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 an in vitro diagnostic (IVD) test that combines the test results of the Lumipulse G pTau 217 Plasma assay and the Lumipulse G ¿-Amyloid 1-42-N Plasma assay from the same patient specimen (K2EDTA plasma sample) into a numerical ratio. The Lumipulse G pTau 217/¿-Amyloid 1-42 Plasma Ratio Instructions For Use (IFU), CL0072, contains instructions on how to manually calculate the ratio and is supplied with 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-1301-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 11, 2025	Details
Brand Name: Single Use Electrosurgical Knife KD-645 Product Name: Olympus Single Use Electrosurgical Knife KD-645 Model/Catalog Number: KD-645L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.	FDA Z-1223-2026	Medical Device	High	Feb 11, 2026 Recall: Feb 17, 2024	Details
PRISMAFLEX ST150 SET US, Product Code 107640US; Dialyzer, High Permeability With Or Without Sealed Dialysate System There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.	FDA Z-1225-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 6, 2026	Details
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-3030 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-1292-2026	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-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-1279-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 7, 2026	Details
Brand Name: Single Use Electrosurgical Knife Product Name: Olympus Single Use Electrosurgical Knife KD-640L Model/Catalog Number: KD640-L Product Description: An electrosurgical device consisting of a handpiece with mechanical and/or electrical controls, and a monopolar electrode, intended to deliver a current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery. A deterioration of the cutting knife, including overheating and burning, can contribute to tip breakage during use.	FDA Z-1222-2026	Medical Device	High	Feb 11, 2026 Recall: Feb 17, 2024	Details
AXIOS Stent and Electrocautery-Enhanced Delivery System - 6mm x 8mm; Material Number (UPN): M00553680; Increased reports of stent deployment and expansion issues. The most common outcome reasonably foreseeable resulting from difficulty deploying the stent is prolongation of the procedure to exchange the device for a new one. The most serious reasonably foreseeable outcome in cases where the first flange is unable to deploy or expand would be a cascade of events resulting in additional intervention, either endoscopic or surgical, to remove the stent and close the puncture site.	FDA Z-1159-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 19, 2025	Details
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
LotFancy Urinary Tract Infection Urine (UTI) Test Strips; PALINOIA UTI-10 PARAMETER REAGENT STRIPS; Vaunn Medical 8-in-1 Urinalysis Reagent Strip; JNW Direct 4-in-1 UTl Urinalysis Test Strips; Urinify STRENGTH; Urinify ESSENTIAL, Urinify Urinary Tract Infection (UTI) Test strips and other tests including for near-patient testing, that require a 510(k) were distributed before they could be legally marketed to U.S. customers; devices may cause false or inaccurate diagnostic result by lay person and lead to inappropriate medical intervention.	FDA Z-1257-2026	Medical Device	High	Feb 11, 2026 Recall: Nov 22, 2025	Details
EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705 942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay to exchange devices or revision surgery.	FDA Z-1233-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 5, 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
PRISMAFLEX HF1000 SET, Product Code 107140; Dialyzer, High Permeability With Or Without Sealed Dialysate System There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.	FDA Z-1229-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 6, 2026	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
PRISMAFLEX TPE2000 SET, Product Code 114093; Dialyzer, High Permeability With Or Without Sealed Dialysate System There is a potential dislodgement of the Prismaflex Set deaeration chamber from the Prismaflex Control Unit.	FDA Z-1231-2026	Medical Device	High	Feb 11, 2026 Recall: Jan 6, 2026	Details
Vortex Surgical 25GA Backflush, VS0270.25; 25GA Backflush Retractable, VS0275.27 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.	FDA Z-1255-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 16, 2025	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
Vortex Surgical I2 Injection Kit, VS0500 There may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has potential of bioburden contamination which could lead to infection.	FDA Z-1252-2026	Medical Device	High	Feb 11, 2026 Recall: Dec 16, 2025	Details

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Medical Device Recalls Today

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