Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

Agency

All agencies FDA (Food)FDA (Drugs)FDA (Devices)USDA FSIS CPSC NHTSA EPA

2576–2600 of 30649

HighFDA (Devices)·Z-1108-2026·2026-01-28
Radiation Therapy Treatment Planning Software Dose Invalidation Bug
RayStation radiation therapy software may fail to invalidate calculated doses in certain cases. The issue affects Regions of Interest without contours that have material overrides or specific types.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 15.2.0, 15.1.3 Software Version: RayStation 2024A SP1, RayStation 2024A SP2 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1109-2026·2026-01-28
RayStation radiation therapy planning system dose invalidation software defect
RayStation treatment planning system version 16.0.0 has a software defect preventing dose recalculation for certain region of interest configurations. The defect affects dose invalidation when specific ROI types lack contours combined with material overrides or bolus classifications.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 16.0.0 Software Version: RayStation 2024B Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1124-2026·2026-01-28
Angiographic Inflation Device Handle May Detach During Procedures
Merit Medical Systems is recalling 173,645 units of the Allwell Inflation Device (Model IS-30-A) due to risk that the handle may detach from the syringe during angiographic procedures.
Product
Allwell Inflation Device, for angiographic use REF: IS-30-A
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1149-2026·2026-01-28
EDAN Patient Monitors Recalled for Cybersecurity Vulnerabilities
Edan Diagnostics is recalling EDAN iX series patient monitors (models iX10, iX12, iX15) due to potential cybersecurity vulnerabilities identified by the FDA.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1155-2026·2026-01-28
EDAN iT20 Telemetry Transmitter Recalled Due to Cybersecurity Vulnerabilities
The FDA has recalled the EDAN iT20 Telemetry Transmitter due to potential cybersecurity vulnerabilities. Approximately 1,457 units were distributed across the United States and Mexico.
Product
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 para
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1113-2026·2026-01-28
Philips Azurion X-Ray System Recalled for Software Malfunction Issues
Philips has recalled the Azurion imaging system (Software Version R3.1) in 228 units worldwide due to two software issues that may cause loss of imaging functionality, motorized movement, incorrect image content, or data loss.
Product
Philips Azurion system; Software Version Number: R3.1;
Category
Medical Device
Distribution
9 states
HighFDA (Devices)·Z-1123-2026·2026-01-28
Merit Medical Inflation Device Handle May Detach During Procedures
Merit Medical Systems is recalling inflation device units because the handle may detach from the syringe during medical procedures. Affected units: 4,163,123 worldwide.
Product
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 IN4
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1105-2026·2026-01-28
Radiation Therapy Planning Software May Not Recalculate Doses When Regions Are Modified
RayStation radiation therapy planning software may fail to invalidate radiation dose calculations when certain regions of interest are modified. This could cause patients to be treated using outdated or incorrect dose values.
Product
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
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1152-2026·2026-01-28
EDAN M3B Vital Signs Monitor Recalled for Potential Cybersecurity Issues
The FDA is recalling EDAN M3B Vital Signs Monitors due to potential cybersecurity vulnerabilities. Approximately 354 units were distributed in hospitals across the U.S. and Mexico.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3B Product Description: M3B Vital Signs Monitor is a patient monitoring device providing the patient with a continuous vital physiological monitoring of arterial blood oxygen saturation (SpO2), Pulse Rat
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1133-2026·2026-01-28
MicroPort hip trial component recalled for missing FDA authorization
MicroPort Orthopedics is recalling its HIPTURN FEM HEAD TRIAL 36MM REUSABLE hip trial component due to distribution without FDA premarket authorization required in the United States.
Product
Brand Name: MicroPort Product Name: HIPTURN FEM HEAD TRIAL 36MM REUSABLE Model/Catalog Number: HTHT0036 Software Version: N/A Product Description: HIPTURN FEM HEAD TRIAL 36MM REUSABLE
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1102-2026·2026-01-28
Radiation Therapy Planning Software Dose Calculation Error in RayStation
RayStation radiation therapy planning software version 10.1 may fail to properly invalidate radiation dose calculations when regions of interest lack contours but have material overrides or are bolus/fixation/support types.
Product
RayStation/RayPlan. Model/Catalog Number: 10.1. Software Version: RayStation/RayPlan 10B. Radiation Therapy Treatment Planning System
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1141-2026·2026-01-28
FDA Recalls EDAN Fetal and Maternal Monitors for Cybersecurity Issues
Edan Diagnostics is recalling EDAN fetal and maternal monitors (models F6, F9, F6 Express, F9 Express) affecting 3,518 units due to potential cybersecurity vulnerabilities.
Product
Brand Name: EDAN Product Name: Fetal & Maternal Monitor Model/Catalog Number: F6, F9, F6 Express, F9 Express Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus f
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1145-2026·2026-01-28
EDAN Patient Monitors Recalled Due to Potential Cybersecurity Vulnerabilities
EDAN patient monitors (models iM50, iM60, iM70, iM80) are being recalled for potential cybersecurity vulnerabilities identified by the FDA.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM50, iM60, iM70, iM80 Product Description: The iM series Patient Monitor including iM50, iM60, iM70 and iM80 can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capa
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1125-2026·2026-01-28
Merit Medical Vascular Waste Kit Inflation Handle May Detach During Procedure
Merit Medical Custom Waste Management Kit Vascular Tray inflation device handles may detach from syringes during medical procedures. This Class II recall affects 864 units distributed worldwide.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1140-2026·2026-01-28
EDAN Fetal Monitors F2 and F3 Recalled for Cybersecurity Vulnerabilities
Edan Diagnostics recalls EDAN fetal monitor models F2 and F3 due to potential cybersecurity issues identified by the FDA. No injuries or illnesses have been reported.
Product
Brand Name: EDAN Product Name: Fetal Monitor Model/Catalog Number: F2, F3 Product Description: The devices are bedside fetal and maternal monitors, which are used to monitor the physiological parameters of pregnant women including the fetus from 28 weeks gestation. The devices
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0458-2026·2026-01-28
Cuban Crackers Recalled for Undeclared Artificial Food Dyes
Cuban Crackers Galletas Cubanas distributed by Best Floridian, LLC have been recalled for undeclared FD&C food dyes: yellow #5, yellow #6, and red 40. The product was distributed only in Florida.
Product
Cuban Crackers Galletas Cubanas, Net Wt 8Oz (226g). Distributed by Best Floridian, LLC. UPC 5700300060
Category
Food
Distribution
0 states
HighFDA (Devices)·Z-1106-2026·2026-01-28
RayStation Radiation Therapy Treatment Planning System Dose Invalidation Error Recall
RayStation radiation therapy treatment planning software (versions 14.0.0, 15.0.0, and 15.1.3) may fail to properly invalidate calculated radiation doses for certain region types. This could result in use of outdated dose calculations in patient treatment planning.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 14.0.0, 15.0.0, 15.1.3 Software Version: RayStation 2023B, RayStation 2024A, RayStation 2024A SP3 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1151-2026·2026-01-28
EDAN Central Monitoring System Recalled for Potential Cybersecurity Vulnerabilities
EDAN Diagnostics is recalling 395 units of its MFM-CNS and MFM-CNS Lite central monitoring systems following an FDA letter regarding potential cybersecurity issues.
Product
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 activ
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1111-2026·2026-01-28
Tego Needle-Free Connectors Recalled for Silicone Seal Separation Risk
ICU Medical is recalling Tego needle-free connectors used in hemodialysis and IV administration because the silicone seal may separate or tear, potentially causing fluid leaks, therapy delays, or exposure to harmful contaminants.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0291-2026·2026-01-28
Diclofenac Sodium Topical Gel Recalled for Failed pH Specifications
Cipla USA is recalling 92,376 tubes of Diclofenac Sodium Topical Gel nationwide due to failed pH specifications. Affected batch XHBG expires August 31, 2027.
Product
DICLOFENAC SODIUM — DICLOFENAC SODIUM (DICLOFENAC SODIUM)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1112-2026·2026-01-28
GE Healthcare Omni Legend PET Systems Streaking Artifact Recall
GE Healthcare Omni Legend PET systems may produce intermittent streaking artifacts in clinical scan images visible on the acquisition console. Approximately 364 units are affected worldwide.
Product
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
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0295-2026·2026-01-28
Icosapent Ethyl Capsules Recalled for Subpotency Due to Capsule Leakage
Zydus Pharmaceuticals is recalling Icosapent Ethyl capsules nationwide due to oxidation caused by capsule leakage, which reduces drug potency. Approximately 22,896 bottles are affected.
Product
Icosapent Ethyl capsules, 1 gram, 120-count bottles, Rx only, Manufactured by: Softgel Healthcare Pvt. Ltd., India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534, NDC 70710-1592-07
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1137-2026·2026-01-28
Rifton TRAM Powered Lift Device Recalled for Fraying Body Support Strap
Community Products recalls the Rifton TRAM (Model K310) powered lift device due to potential fraying on the body support strap. Approximately 3,238 units were distributed worldwide.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1154-2026·2026-01-28
EDAN iM8 Series Patient Monitors Recalled for Potential Cybersecurity Vulnerabilities
FDA has issued a recall for EDAN iM8 series patient monitors due to potential cybersecurity vulnerabilities identified in an IHCTOA letter. Approximately 3,141 units are affected across multiple U.S. states and Mexico.
Product
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 cont
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·H-0412-2026·2026-01-28
Gacen¿iga Authentic Cuban Loaf Cake recalled for undeclared food color
CATAO MARKET LLC is recalling Gacen¿iga Authentic Cuban Loaf Cake (24 oz) due to undeclared FD&C Yellow #5. The product was distributed in Florida with Best By dates from 12/18/2025 through 03/18/2026.
Product
Gacen¿iga Authentic Cuban Loaf Cake Classic (Net Wt. 24 oz (680g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 24 oz per master case.
Category
Food
Distribution
1 state

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