Product Name Or Brand
Start broad with the product name, manufacturer, retailer brand or model family. This is usually the fastest way to find a possible notice.
Start with the product name or brand. If the list is too broad, search the exact UPC, lot code, model number, date code, NHTSA campaign number or official recall number printed on the notice or label.
Results help you find a possible match quickly. Before you stop use, discard, return or repair anything, open the official notice and confirm every affected detail.
| Product Recall | Source | Type | Risk | Date | Action |
|---|---|---|---|---|---|
|
Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 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-1293-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
The Girlfriend Doctor Dr. Anna Cabeca Keto-pH-Uric Acid Test Strips; URIMED Urinalysis Reagent Strips URS-5, Rapid UTI Test Includes Ketones: Leukocytes, Nitrite, pH, Ketone, Protein; Vivoo Ketone Test
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-1258-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 22, 2025
|
Details |
|
Tecfen Retractable Membrane Polisher, QTPR1267-23
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-1251-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 16, 2025
|
Details |
|
NAEOTOM Alpha 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-1240-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 19, 2025
|
Details |
|
TORNIER PERFORM REVERSED PERIP SCREW 5.0MMX18MM NON STERILE, catalog number DWJ318
A specific lot of screws is incorrectly labeled. Screws are labeled as 5.0mmx18mm but actual screws are 5.00mmx14mm. If mismatch is detected during surgery, the issue may cause a minor delay in surgery. If not detected and incorrect screw is used, issue may increase risk of earlier mechanical failure, loosening, and need for revision surgery.
|
FDA
Z-1237-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 19, 2025
|
Details |
|
Product Name: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges Model/Catalog Number: 235447 Software Version: Not Applicable Product Description: Lumipulse G ¿-Amyloid 1-42-N Plasma Immunoreaction Cartridges (IRC): Lumipulse G ¿-Amyloid 1-42-N Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G ¿-Amyloid 1-42-N Plasma IRC), for the quantitative measurement of ¿-Amyloid 1-42 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology13 by a specific two-step immunoassay method on the LUMIPULSE G System. Lumipulse G ¿-Amyloi
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-1305-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 11, 2025
|
Details |
|
Product Name: Single Use 3-Lumen Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC411Q-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-1281-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V431M-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 |
Use brand, product name, UPC, lot code, best-by date, package size, allergen, contamination issue or distribution state.
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Read the product description, recall reason, hazard, affected dates, source agency and official recall number before taking action.
Compare the UPC, lot, best-by date, establishment number, model, serial range, color, size, state, retailer and product photo.
The notice may say stop using, do not eat, discard, return for refund, request a repair kit, replace a part or schedule dealer service.
Do not rely on brand alone. Match the package size, UPC, lot code, best-by date, use-by date, distribution states and any allergy or contamination warning.
Look for model number, date code, serial range, color, size, online listing, product photo and the exact hazard such as choking, suffocation, fire or fall risk.
Use campaign results to understand the issue, then verify your VIN, car seat model or tire information with NHTSA or the manufacturer.
Your item may not be part of that specific recall. Check spelling, older notices, retailer alerts and the official source before deciding it is safe.
A product recall is a safety or compliance notice saying a product may need to be corrected, removed, returned, repaired, replaced, refunded or discarded.
If all affected details match, follow the official instructions. Keep packaging, take photos, save receipts and contact the company or retailer when a refund or repair is offered.
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Be careful with text messages, social posts or refund forms that ask for private information. Verify the notice through an official agency, retailer or manufacturer page.
Yes, when the official recall notice includes a UPC or product code. If no result appears, also search the brand, product name, package size, lot code and company name.
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The database combines multiple official U.S. sources, but agencies and companies can publish or update notices at different times. Always check the linked official notice before taking final action.