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

2551–2575 of 30649

HighFDA (Devices)·Z-1130-2026·2026-01-28
Surgical Laser Device Missing Required Danger Symbol on Console
The Leaseir MHR Xcell surgical laser is missing a required 'DANGER' symbol on its console label. This labeling deficiency may prevent operators from being adequately warned of the device's hazards.
Product
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 treatm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1121-2026·2026-01-28
SIGMA Spectrum Infusion Pump defective grease may cause over-infusion
Certain SIGMA Spectrum Infusion Pumps (Model 35700BAX2) contain defective grease on internal gears that may cause insufficient lubrication, leading to premature wear and potential over-infusion or free-flow. Baxter is recalling 585 units distributed nationwide.
Product
SIGMA Spectrum Infusion Pump, Model/Catalog Number: 35700BAX2
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1126-2026·2026-01-28
Merit Medical Custom Inflation Kit handle detachment during medical procedure
Merit Medical is recalling 18,897 Custom Inflation Kits because the inflation device handle may detach from the syringe during use, potentially affecting device function.
Product
Merit Medical , Custom Inflation Kit REF: K05-00761F K05-01717B K05-02080D K05-02090C K05-02221 K05-02338 K05-02470 K05-02954 K05-03094A K05T-00380C K05T-01674B K05T-01863 K05T-01915 K05T-01920F K05T-01955 K05T-02138 K05T-02138A K05T-02272G K05T-02272H K05T-02533 K05T-03153 K05T
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1107-2026·2026-01-28
Radiation therapy planning software recalled for dose calculation defect
RayStation radiation therapy planning software version 10B SP1 has a defect where dose calculations fail to invalidate properly when certain regions of interest are modified, potentially affecting treatment planning accuracy.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 10.1.1 Software Version: RayStation 10B SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1144-2026·2026-01-28
EDAN Vital Signs Monitors recalled for cybersecurity vulnerabilities
EDAN vital signs monitors (iM3s series) are being recalled due to potential cybersecurity issues identified by the FDA. Approximately 136 units distributed nationwide and in Mexico are affected.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: iM3s, iM3As, iM3Bs, iHM3s Product Description: The iM3s series vital signs monitors including iM3s/iM3As/iM3Bs/iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts fo
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1128-2026·2026-01-28
Custom Procedure Kit Inflation Device Handle Detachment Risk
Merit Medical custom procedure kits contain inflation devices whose handles may detach from the syringe during medical procedures, potentially compromising procedure execution.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1136-2026·2026-01-28
TS-10 and TS-10H Tube Sorters recalled due to lift disengagement risk
Sysmex America is recalling 44 TS-10/TS-10H Tube Sorters nationwide due to a mechanical defect where the electromagnetic holding force may disengage unexpectedly, causing the lift to drop.
Product
TS-10/TS-10H Tube Sorter, automatic sorting system for sorting barcoded sample tubes, Catalog Number BN168792, running software versions 00-17
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1131-2026·2026-01-28
VOLT Wrist System Surgical Plate Recalled Due to Incorrect Thread Orientation
Tyber Medical is recalling a distal radius surgical plate due to incorrect thread orientation in anatomical left plates. This manufacturing defect may affect proper placement or stability of the implant.
Product
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1122-2026·2026-01-28
Mazor X Robotic Guidance System Recalled for Software Positioning Errors
Mazor Robotics is recalling the Mazor X robotic guidance system due to software errors that can cause incorrect surgical instrument positioning during spinal surgery. The recall affects approximately 549 systems distributed worldwide.
Product
Mazor X robotic guidance system REF: TPL0059
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2026·2026-01-28
LDL-Cholesterol Assay Performance Deviation Due to Triglyceride Interference
Beckman Coulter is recalling LDL-Cholesterol assay reagent that shows clinically significant interference from high triglyceride levels, causing measurement bias up to 28.8% in low samples and 11.02% in high samples.
Product
The LDL-Cholesterol assay is comprised of two distinct phases. In phase one a unique detergent solubilizes cholesterol from non-LDL- lipoprotein particles. This cholesterol is consumed by cholesterol esterase, cholesterol oxidase, peroxidase and 4- aminoantipyrine to generate a c
Category
Medical Device
Distribution
52 states
HighFDA (Devices)·Z-1134-2026·2026-01-28
Ion Vision Probe Bag Recalled for Compromised Sterile Seals
Intuitive Surgical recalls 110,580 Ion Vision Probe Bags that may have compromised or incomplete sterile seals. Non-sterile devices used in surgical procedures could pose an infection risk.
Product
Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software Version: N/A Product Description: The Ion Endoluminal System is a robotically assisted platform for minimally invasive peripheral lung biopsy. Ion consists of a System
Category
Medical Device
Distribution
51 states
HighFDA (Devices)·Z-1138-2026·2026-01-28
Rifton Low Base TRAM Patient Lift Device Recalled for Body Support Strap Fraying
Rifton Equipment is recalling approximately 1,096 Low Base TRAM powered lift devices (Model K320) due to potential fraying of the body support strap. The affected devices were distributed worldwide.
Product
Rifton Equipment, Low Base TRAM. Model/Catalog Number: K320. 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. The low base variant includes smaller casters and lower base frame so that th
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1147-2026·2026-01-28
EDAN iM20 Patient Monitor recalled due to potential cybersecurity issues
Edan Diagnostics is recalling approximately 377 EDAN iM20 Patient Monitors due to potential cybersecurity vulnerabilities identified by the FDA. No injuries have been reported.
Product
Brand Name: EDAN Product Name: Patient Monitor Model/Catalog Number: iM20 Product Description: The iM20 Patient Monitor System (hereinafter called iM20) can perform long-time continuous monitoring of multiple physiological parameters, including ECG, respiration (RESP), non-inv
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
Blood Transfusion Filter Recall Due to Unconfirmed Sterility
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters because they were released before completing required quality control testing. Sterility assurance cannot be confirmed.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
HighFDA (Food)·H-0406-2026·2026-01-28
Frozen Australian Greenlip Abalone Recalled for Potential Listeria Contamination
Frozen Australian Greenlip Abalone from Southern Rocklobster LTD USA is being recalled due to potential Listeria monocytogenes contamination. The affected product was distributed to multiple locations in California.
Product
Australian Greenlip Abalone, Frozen, 9 pieces, Net Wt. 23.5 OZ UPC: 9335533013342
Category
Food
Distribution
0 states
HighFDA (Food)·H-0411-2026·2026-01-28
Multiple food products from GOLD STAR DISTRIBUTION recalled for potential rodent contamination
GOLD STAR DISTRIBUTION INC is recalling all human food products distributed from its facility due to potential rodent exposure and activity. Affected products were distributed to Indiana, Minnesota, and North Dakota.
Product
All human food products distributed from the firm. Including but not limited to: snack foods, candy, gum, cooking oil, canned fruit and beans, honey, Dietary supplements, peanut butter, oatmeal, rice, dry peas and beans, ramen, cold cereal, hot sauce, lemon juice, crackers, can
Category
Food
Distribution
3 states
HighFDA (Food)·H-0457-2026·2026-01-28
Meal Simple Red Lentil Dal Soup Recalled for Undeclared Milk
Bakkavor's Meal Simple Red Lentil Dal Soup is being recalled due to undeclared milk and wrong product in containers. Consumers with milk allergies should not consume this product.
Product
MEAL SIMPLE RED LENTIL DAL SOUP NET WT. 16 OZ (1 LB) 454g UPC 1 97870 07333 0 MADE WITH PRIDE AND CARE FOR H-E-B-, SAN ANTONIO, TEXAS 78204
Category
Food
Distribution
1 state
HighFDA (Drugs)·D-0293-2026·2026-01-28
Prescription Furosemide Tablets Recalled for Foreign Substance Contamination
Graviti Pharmaceuticals recalls Furosemide 40 mg tablets nationwide. Affected lot FUB125042G (expires 05/13/2027) contains a foreign substance. Patients taking this medication should contact their pharmacist or doctor immediately.
Product
FUROSEMIDE — FUROSEMIDE (FUROSEMIDE)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Food)·H-0413-2026·2026-01-28
Gaceniga Authentic Cuban Loaf Cake Recalled for Undeclared Food Coloring
CATAO MARKET LLC is recalling Gaceniga Authentic Cuban Loaf Cake Raisins due to undeclared FD&C Yellow #5. Affected packages with Best By dates from 12/18/2025 to 03/18/2026 were distributed in Florida.
Product
Gaceniga Authentic Cuban Loaf Cake Raisins (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
HighFDA (Drugs)·D-0294-2026·2026-01-28
FDA Recalls Subpotent Thyroid Drug Ingredient from Specialty Process Labs
Specialty Process Labs is recalling thyroid USP ingredient due to subpotency—the active ingredient is below the required strength. The affected batch was distributed nationwide and is used in manufacturing, processing, or repackaging.
Product
Thyroid, USP, Rx only, Net Wt: 0.50kg, For Manufacturing, Processing or Repackaging Use Only, Specialty Process Labs, Phoenix, AZ 85034, NDC 81305-100-02
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1153-2026·2026-01-28
EDAN Vital Signs Monitor recalled for potential cybersecurity vulnerabilities
Edan Diagnostics is recalling EDAN Vital Signs Monitor Model M3A devices due to potential cybersecurity vulnerabilities identified by the FDA.
Product
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-in
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1139-2026·2026-01-28
E-Pacer gait training devices recalled for potential body support strap fraying
Rifton E-Pacer gait training devices (Model K660) are being recalled because their body support straps may fray during use. This could affect patients' safety during gait training activities.
Product
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.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-0415-2026·2026-01-28
Undeclared Food Coloring Found in Mini Gaceniga Cuban Loaf Cake Recall
Mini Gaceniga Authentic Cuban Loaf Cake Classic is being recalled because it contains undeclared FD&C Yellow #5, a food coloring. The recall affects 385 master cases distributed in Florida.
Product
Mini Gaceniga Authentic Cuban Loaf Cake Classic (Net Wt. 12 oz (340g)) packaged in wax paper, placed in clear bag and packed in cardboard carton. 12/ 12 oz per master case.
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-1110-2026·2026-01-28
RayStation radiation therapy treatment planning software dose invalidation defect
RayStation v17.0.0 and v17.0.1 fail to properly invalidate dose calculations for certain regions of interest. The system may not recalculate radiation doses when geometry changes or material overrides are removed.
Product
Brand Name: RayStation Product Name: RayStation/RayPlan Model/Catalog Number: 17.0.0, 17.0.1 Software Version: RayStation v2025, RayStation v2025 SP1 Product Description: Radiation Therapy Treatment Planning System Component: No
Category
Medical Device
Distribution
0 states
HighFDA (Devices)·Z-1142-2026·2026-01-28
EDAN Vital Signs Monitor M3 Recalled Due to Cybersecurity Vulnerability
Edan Diagnostics is recalling the EDAN Vital Signs Monitor Model M3 following an FDA letter regarding potential cybersecurity issues. Approximately 13,934 units were distributed in 14 U.S. states and Mexico.
Product
Brand Name: EDAN Product Name: Vital Signs Monitor Model/Catalog Number: M3 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-inv
Category
Medical Device
Distribution
Distributed nationwide

Filters

2551–2575 of 30649