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 |
|---|---|---|---|---|---|
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Brand Name: LEASEIR Product Name: LEASEIR MHR XCELL Model/Catalog Number: MHR 110-b Software Version: 1.5.0.0 Product Description: The Leaseir MHR Xcell is a surgical laser instrument for use in general and plastic surgery and dermatology, intended for hair removal and treatment of pseudo folliculitis barbae on all skin types (Fitzpatrick I-VI). The process implies the generation of intense light pulses at specific wavelengths. The specific nature of the energies and pulse durations cause the desired effect (in the hair follicles and oxyhemoglobin in the blood) heating them sufficiently and de
The console label for affected devices is missing the "DANGER" symbol.
|
FDA
Z-1130-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 15, 2025
|
Details |
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Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3 Product Description: The iM3 has three work modes, Monitor, Spot and Round, to measure physiological parameters, including non-invasive blood pressure (NIBP), oxygen saturation of the blood (SpO2), pulse rate (PR), and Quick TEMP/Infrared TEMP (TEMP). iM3 capabilities include storing, displaying measuring data. When necessary, alarms will be produced so that doctors and nurses can manage patient care appropriately. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1143-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
RayStation/RayPlan. Model/Catalog Numbers: 11.0.0, 11.0.1, 11.0.3, 11.0.4. Software Version: RayStation 11A, RayStation 11A SP1, RayStation 11A SP2, RayStation 11A SP3. Radiation Therapy Treatment Planning System
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
|
FDA
Z-1103-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 28, 2025
|
Details |
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM8, iM8A, iM8B Product Description: iM8 Series Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The patient monitor supports software upgrade online and networking and build-in battery power is available for all the models. iM8 Series Patient Monitor can monitor physiological parameters inclu
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1154-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
Rifton Equipment, E-Pacer. Model/Catalog Number: K660. The E-Pacer is a gait training device with power height adjustment that facilitates the sit-to-stand motion.
Potential for fraying on the body support strap.
|
FDA
Z-1139-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 18, 2025
|
Details |
|
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
The supplier manufactured anatomical left plates with an incorrect thread orientation.
|
FDA
Z-1132-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 19, 2025
|
Details |
|
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 13.0.0.1547, 13.1.0.144, 13.1.1.89 Software Version: RayStation 12A, RayStation 12A SP1, RayStation 12A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
|
FDA
Z-1105-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 28, 2025
|
Details |
|
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Inflation device handle may detach from the syringe during procedure.
|
FDA
Z-1125-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 4, 2025
|
Details |
|
Merit Medical , Custom Manifold Kit REF: K09-13203A
Inflation device handle may detach from the syringe during procedure.
|
FDA
Z-1127-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 4, 2025
|
Details |
|
RayStation/RayPlan. Model/Catalog Numbers: 12.0.0, 12.1.0, 12.0.3, 12.0.4, 12.3.0. Software Version: RayStation 11B, RayStation 11B SP1, RayStation 11B SP2, RayStation 11B SP3, RayStation 11B SPT1. Radiation Therapy Treatment Planning System
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 contours and either have a material override defined, or are of type Bolus, Fixation, or Support. In these cases, adding geometry to the ROI, subsequently modifying geometry, or removing the material override does not invalidate dose as intended.
|
FDA
Z-1104-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 28, 2025
|
Details |
|
Rifton Equipment, TRAM. Model/Catalog Number: K310. The TRAM is a powered lift device for transferring clients in a seated position or assisting in a sit-to-stand transfer and gait training.
Potential for fraying on the body support strap.
|
FDA
Z-1137-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 18, 2025
|
Details |
|
MEDLINE beds labeled as: 1) Full Electric Basic Homecare Bed, REF MDR107003E; 2) Full Electric Basic Homecare Bed, 4-pack,REF MDR107003E-4.
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
|
FDA
Z-1013-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 26, 2025
|
Details |
|
GE Healthcare Omni Legend, sold under the following names: OMNI Legend 16, Omni Legend 21, OMNI Legend 32, Omni Legend PET Gantry 16cm - MEA, Omni Legend PET Gantry 16cm Haifa LM, Omni Legend PET Gantry 16cm Mobile, Omni Legend PET Gantry 21cm - BJ for Global, Omni Legend PET Gantry 21cm - Global Haifa LM, Omni Legend PET Gantry 21cm - Mobile, Omni Legend PET Gantry 21cm WSO LM, Omni Legend PET Gantry 32cm - MEA, Omni Legend PET Gantry 32cm Haifa LM, Omni Legend PET Gantry 32cm Mobile, OMNI PET Gantry 15cm, Omni PET Gantry 15cm - WSO, OMNI PET Gantry 15cm Cardiac- WSO, OMNI PET Gantry 15cm ES
There is a potential intermittent issue on certain Omni Legend systems that can result in a streaking artifact in the PET clinical scan images. This streaking artifact is most easily identified in transaxial slices on the acquisition console (both corrected and non-corrected for attenuation).
|
FDA
Z-1112-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 24, 2025
|
Details |
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: elite V5, elite V6, elite V8 Product Description: V series Patient Monitor including elite V5, elite V6 and elite V8 which can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time. The V series Patient Monitor realize the monitoring of physiological parameters by configuration with different parameter modules which in
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1146-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
ICU Medical Plum Solo Precision IV Pump, List Numbers: 400010401 (US), 400011001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
|
FDA
Z-1120-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 15, 2025
|
Details |
|
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Needle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a silicone seal which may bulge at the top, separate from the body, tear; may result in fluid leaks, occluded fluid flow, inability to inject/withdraw blood product, delayed/interrupted therapy, exposure to biological contaminants, air infused into the body
|
FDA
Z-1111-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 19, 2025
|
Details |
|
ICU Medical Plum Duo Infusion Pump, List Numbers: 400020401 (US), 400021001 (Philippines)
Plum Solo and Duo Infusion pumps include a feature, that when selected, automatically flushes the downstream line after a piggyback therapy. The programmed flush volume is delivered from the primary line container at the piggyback therapy rate after the piggyback therapy is complete. In certain cases, as described below, the clinician may receive an Upper Hard Limit (UHL) or Lower Hard Limit (LHL) Violation message when programming a piggyback flush, which prevents the flush from being programmed.
|
FDA
Z-1118-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 15, 2025
|
Details |
|
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iX10, iX12, iX15 Product Description: The iX series Patient Monitors including iX10, iX12, iX15 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormalities so that doctors and nurses can respond to the patient's situation as appropriate. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1149-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
MEDLINE beds labeled as: Full Electric Low Basic Homecare Bed, REF MDR107003ELO
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
|
FDA
Z-1014-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 26, 2025
|
Details |
|
Brand Name: EDAN Product Name: Telemetry Transmitter Model/Catalog Number: iT20 Product Description: iT20 collects physiological parameters by ECG cables and SpO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM-CMS via Wi-Fi. The parameters supported are ECG, SpO2 and PR. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1155-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference Numbers: ENDO-AN2030/B IN4130/CNK IN4130/H IN4130/JPH IN4130/K IN4130/KRK IN4130/L IN4130/T IN4230/JPH IN4230/K IN4330/CNK IN4330/K IN4352/K IN4430/K IN4530/CNK IN4530/K IN4530/T IN4802/K IN4802/T IN4852/K IN4901/A IN4902/A IN4903/A IN4904/A IN4905/A IN4906/A IN4907/A IN4908 IN4909 IN4910 IN4911/A IN4912 IN4913/A IN4914/A IN4915 IN4916/A IN4917/A IN4918/A IN4919/A
Inflation device handle may detach from the syringe during procedure.
|
FDA
Z-1123-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 4, 2025
|
Details |
|
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3A Product Description: The Vital Signs Monitor is a portable device intended for use by health care professionals. The monitor could provide the monitoring of physiological parameters such as the non-invasive blood pressure (NIBP), the oxygen saturation of the blood (SpO2) and Rectal/Oral/Auxiliary/Ear temperature measurement. Component: No
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1153-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Medline Industries has identified a potential hazard involving the hand control pendant and associated wires. In rare and atypical scenarios such as operating the bed above its specified weight limit, encountering an obstruction to bed movement, or experiencing jammed components/motor the hand pendant and pendant cords may overheat and, in rare instances, pose a risk of fire. Medline Industries, LP has received a total of (58) complaints associated with reports of pendant sparking, burning, melting, smoking or fire.
|
FDA
Z-1015-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Nov 26, 2025
|
Details |
|
Brand Name: EDAN Product Name: Central Monitoring System Model/Catalog Number: MFM-CNS, MFM-CNS Lite Product Description: The MFM-CNS and MFM-CNS Lite are clinical data managing software applications. Both applications manage clinical data of fetal monitoring and uterine activity, and the MFM-CNS additional monitors maternal vital signs. Data are automatically acquired from bedside monitors, for the purpose of collecting. processing and saving the patient and/or clinical data that is normally provided on record papers and/or separate bedside monitors. They provide electronic medical records an
As a result of receiving an FDA It Has Come to Our Attention Letter (IHCTOA Letter) regarding potential cybersecurity issues with various of the firm device.
|
FDA
Z-1151-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Oct 24, 2025
|
Details |
|
Allwell Inflation Device, for angiographic use REF: IS-30-A
Inflation device handle may detach from the syringe during procedure.
|
FDA
Z-1124-2026
|
Medical Device | High |
Jan 28, 2026
Recall: Dec 4, 2025
|
Details |
Use brand, product name, UPC, lot code, best-by date, package size, allergen, contamination issue or distribution state.
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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.
A similar brand or product name is not enough. UPCs, lot codes, dates, model numbers, serial ranges and distribution areas determine whether your item is included.
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.