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 |
|---|---|---|---|---|---|
|
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 Cartridges (IRC): Lumipulse G pTau 217 Plasma is an assay system, including a set of immunoassay reagents (Lumipulse G pTau 217 Plasma IRC), for the quantitative measurement of pTau 217 in K2EDTA plasma specimens based on chemiluminescent enzyme immunoassay (CLEIA) technology by a specific two-step immunoassay method on the LUMIPULSE G System. 3 ¿ 14 Tests: 3 racks, 14 IRCs per rack, 1 test per IRC. Each
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-1302-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 11, 2025
|
Details |
|
Brand Name: Molift Product Name: Molift Mover 300 Model/Catalog Numbers: (1) M1501, (2) M1502, (3) M1504, (4) M15050, (5) M15151, (6) M15001, (7) M15002; Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength. Component: The deformation occurs between the bolt and the fork
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
|
FDA
Z-1309-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 17, 2025
|
Details |
|
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 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-1283-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
Product Name: Nasal Jejunal Feeding Tube REF: NJFT-10
Nasal feeding tube packaged without the nasal transfer tube component.
|
FDA
Z-1298-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 15, 2025
|
Details |
|
EMPOWR Acetabular System: Liner, 10 degree Hooded, HXe+, 36H, REF: 942-01-36H; Liner, 10 degree Hooded, HXe+, 36J, REF: 942-01-36J; Liner, 10 degree Hooded, HXe+, 40G, REF: 942-01-40G; Liner, 10 degree Hooded, HXe+, 32C, REF: 942-01-32C
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-1234-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 5, 2026
|
Details |
|
Rumex Disposable Diamond Dusted ILM Elevator, 12-7523
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-1253-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 16, 2025
|
Details |
|
NAEOTOM Alpha.Prime 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-1241-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 19, 2025
|
Details |
|
Brand Name: Molift Product Name: Molift 2-point sling bars (Accessory to mobile hoists) Model/Catalog Numbers: (1) 1530101, (2) 1530102 Product Description: The mobile hoist is an assistive device intended for alleviation of, or compensation for, a functional, impairment due to an injury or disability. The device is designed for an individual lacking the ability to stand up and transfer themselves to / from a bed, the floor, a wheelchair, a chair, a toilet or similar due to reduced mobility or physical strength.
A customer experienced that during assembly and load testing of the device, the bolt for mounting the lifting bar broke. Upon further investigation of this customer complaint, it became clear that the defect occurs as a result of deformation of the materials involved between the lifting bar and the arm of the device. Such deformation can lead to limited mobility in the joint, which prevents proper functionality of the equipment.
|
FDA
Z-1310-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 17, 2025
|
Details |
|
Volk Single Use Vitrectomy Lenses 1. Flat Vitrectomy Lens, Catalog VFD 2. Volk Magnifying Lens, Catalog VMD
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-1244-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 16, 2025
|
Details |
|
Bubble Sensor for 3/8" x 3/32" tubing; Model Number: 701055720;
Internal investigations have identified an issue with the durability of the connecting cable near the connection to the Venous Bubble Sensor. Excessive bending of the connecting cable can lead to full damage of the Venous Bubble Sensor or loose cable contact, which may trigger the errors Ven. bubble sensor defective or Ven. bubble sensor disconnected on the connected medical device. These errors can occur temporarily when the connecting cable is moved or permanently if the connection is fully compromised.
|
FDA
Z-1300-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 9, 2026
|
Details |
|
LH One Step Ovulation Test Device (Urine)
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-1259-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 22, 2025
|
Details |
|
AXIOS Stent and Electrocautery-Enhanced Delivery System - 8mm x 8mm; Material Number (UPN): M00553690;
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-1160-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 19, 2025
|
Details |
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-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-1272-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0725 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-1294-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
*HOT AXIOS Stent and Electrocautery-Enhanced Delivery System 8mm x 8mm; Material Number (UPN): M00553530;
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-1162-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 19, 2025
|
Details |
|
Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-1530 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-1291-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
Product Name: Single Use Sphincterotome V (Distal Wire guided) Model/Catalog Number: KD-VC431Q-0720 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-1269-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
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: The ¿-Amyloid 1-42 plasma concentration of a specimen is automatically calculated from the calibration curve, which is automatically calculated from calibration data. The result of the calculation is reported in pg/mL. Lumipulse G ¿-Amyloid 1-42-N Plasma Calibrators: Liquid (Frozen), 1 ¿ 1.5 mL (4 Concentrations) CAL 1 0 pg/mL ¿-Amyloid 1-42-N Plasma Calibrator CAL 2 30 pg/mL ¿-Amyloid 1-42-N Plasma Cal
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-1306-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 11, 2025
|
Details |
|
Vortex Disposable Forceps and Cannula 1. 23GA ACTU8 Forceps Adaptive VS0740.23 2. 25GA ACTU8 Forceps Adaptive VS0740.25 3. 25GA ACTU8 Forceps ILM VS0744.25 4. 25GA ACTU8 Forceps ILM -Myopic VS0744.25-35 5. 25GA ACTU8 Forceps Pro-Grip VS0713.25 6. 25GA ACTU8 Talon Forceps ILM VS0752.25 7. 25GA ACTU8 Talon Forceps Pro-Grip VS0751.25 8. 27GA ACTU8 Forceps ILM VS0744.27 9. 23GA Soft Tip Cannula VS0200.23 10. 23GA Soft Tip Cannula - 0.5mm VS0205.23 11. 25GA Soft Tip Cannula VS0200.25 12. 25GA Soft Tip Cannula - 0.5mm VS0205.25 13. 25GA Soft Tip Cannula - 0.5mm - Bulk VS0205.25B 14. 25GA Soft Tip Ca
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-1247-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 16, 2025
|
Details |
|
CellMek SPS Sample Preparation System, REF: C44603, with software
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 could dislodge fluid line, result in sample loss, spillage, make instrument inoperable and will lead to unintentional removal of 60-100 microliters from final sample, may lead to incorrect diagnosis or patient management.
|
FDA
Z-1235-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 23, 2025
|
Details |
|
PRISMAFLEX HF1000 SET, Product Code 107142; 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-1230-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 6, 2026
|
Details |
|
25GA Subretinal Injection Cannula VS0220.25
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-1248-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Dec 16, 2025
|
Details |
|
Vivoo Sodium Test; Vivoo Vitamin C Test; Vivoo Hydration 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-1267-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 22, 2025
|
Details |
|
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 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-1282-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Jan 7, 2026
|
Details |
|
Vivoo pH 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-1264-2026
|
Medical Device | High |
Feb 11, 2026
Recall: Nov 22, 2025
|
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.
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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.
Yes. Lot codes are especially useful for food, drug, cosmetic and pet food recalls because only certain production batches may be affected.
No. This tool helps find vehicle recall campaigns and NHTSA numbers. Use the official NHTSA VIN or license plate lookup for vehicle-specific unrepaired recall status.
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.