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.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means deaths or serious injuries are reported, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Agency

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

1451–1475 of 27346

HighFDA (Devices)·Z-1109-2026·2026-01-28
RayStation 2024B treatment planning recalled over dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 16.0.0 because calculated radiation dose is not invalidated as intended for certain regions of interest.
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-1107-2026·2026-01-28
Blood transfusion filters recalled over unconfirmed sterility assurance before release
GVS TM is recalling 2,720 SQ40S Blood Transfusion Filters from one lot because they were released for distribution before the required quality control release process was completed.
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-1125-2026·2026-01-28
Waste management vascular trays recalled over inflation handles that may detach
Merit Medical Systems is recalling 864 units of its Custom Waste Management Kit Vascular Tray because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Waste Management Kit Vascular Tray REF: K10T-05261
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1129-2026·2026-01-28
Angioplasty packs recalled over inflation handles that may detach
Merit Medical Systems is recalling 328,000 units of the Allwell Angioplasty Pack because the inflation device handle may detach from the syringe during a procedure.
Product
Allwell Angioplasty Pack REF: IS-30-B1/B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1015-2026·2026-01-28
Red lentil dal soup recalled over undeclared milk and wrong contents
Bakkavor is recalling 291 cases of H-E-B Meal Simple Red Lentil Dal Soup over undeclared milk, with the record citing the wrong product in the container.
Product
MEDLINE beds labeled as: Full Electric Lightweight Homecare Bed, REF MDR107003L
Category
Food
Distribution
4 states
HighFDA (Devices)·Z-1128-2026·2026-01-28
Custom procedure kits recalled over inflation handles that may detach
Merit Medical Systems is recalling its Custom Procedure Kit because the inflation device handle may detach from the syringe during a procedure.
Product
Merit Medical , Custom Procedure Kit Reference Numbers: K12T-04270A K12T-07956 K12T-10922B
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1135-2026·2026-01-28
LDL cholesterol assays recalled over triglyceride interference causing biased results
Beckman Coulter is recalling 34,451 units of the LDL Cholesterol OSR6x96 assay because triglyceride interference may cause a positive bias of up to 28.8% in low LDL cholesterol 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-1145-2026·2026-01-28
Endoluminal vision probe bags recalled over compromised sterile pouch seals
Intuitive Surgical is recalling 110,580 Ion Vision Probe Bags because the probe bags may have a compromised or incomplete sterile pouch seal.
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-1111-2026·2026-01-28
Needle free access connectors recalled over silicone seals that may tear
ICU Medical is recalling 14,684,607 Tego Connectors because the silicone seal may bulge, separate from the body or tear, which can cause fluid leaks, occluded flow or air infused into the body.
Product
Tego Connector: REF: 011-D1000, 01C-D1000, 055-D1000, D1000; Conector Tego: REF: LAT-D1000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1157-2026·2026-01-28
RayStation 10B SP1 recalled over radiation dose that fails to invalidate
RaySearch Laboratories is recalling RayStation/RayPlan model 10.1.1 because calculated radiation dose is not invalidated as intended for certain regions of interest.
Product
SQ40S Blood Transfusion Filter
Category
Medical Device
Distribution
28 states
CriticalFDA (Devices)·Z-1020-2026·2026-01-21
Glucose monitoring sensors recalled over carbon build up causing low readings
Abbott Diabetes Care is recalling 1,060,723 FreeStyle Libre 3 sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
Product
FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The FreeStyle Libre 3 sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
CriticalFDA (Devices)·Z-1022-2026·2026-01-21
Libre 3 Plus sensors, REF 78769-01, recalled over carbon build up
Abbott Diabetes Care is recalling 258,913 FreeStyle Libre 3 Plus sensors, REF 78769-01, because carbon build up in the sensor may result in incorrect low glucose results.
Product
FreeStyle Libre 3 Plus Sensor REF 78769-01 UDI-DI code: 00357599843014 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
CriticalFDA (Devices)·Z-1021-2026·2026-01-21
Libre 3 Plus sensors recalled in a second lot over carbon build up
Abbott Diabetes Care is recalling 1,663,241 FreeStyle Libre 3 Plus sensors, REF 78768-01, because carbon build up in the sensor may result in incorrect low glucose results.
Product
FreeStyle Libre 3 Plus Sensor REF 78768-01 UDI-DI code: 00357599844011 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
CriticalFDA (Devices)·Z-1023-2026·2026-01-21
Libre 3 Plus sensors recalled over carbon build up causing low readings
Abbott Diabetes Care is recalling 8,062 FreeStyle Libre 3 Plus sensors because a manufacturing process issue may cause carbon build up that results in incorrect low glucose results.
Product
FreeStyle Libre 3 Plus Sensor REF 72080-01 UDI-DI code: 00357599819002 The FreeStyle Libre 3 Plus sensor is a component of the FreeStyle Libre 3 Continuous Glucose Monitoring System.
Category
Medical Device
Distribution
36 states
CriticalFDA (Devices)·Z-1052-2026·2026-01-21
Holiday cookie tins recalled over undeclared almond, pecan and walnut
One Roof LLC is recalling 197 Atwater's Holiday Cookie Tins over undeclared tree nut allergens: almonds, pecans and walnuts.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) RR-LE FORT MANDIBLE PACK-LF, Medline Kit SKU DYNJ0785864R; 2) RR-ASC EAR PACK-LF, Medline Kit SKU DYNJ0792607R.
Category
Food
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1092-2026·2026-01-21
Patient positioning systems recalled over stereotactic radiosurgery tolerance errors
C-RAD Positioning is recalling 189 Catalyst and Catalyst+ systems because the system may indicate a patient as correctly positioned at the isocenter when it is outside tolerance.
Product
Brand Name: Catalyst+ Product Name: Catalyst, Catalyst+ Model/Catalog Number: SP001-0026, SP003-0002 Software Version: cSRS module in combination with cMotion module Product Description: GMDN: 40893 Patient positioning device, diagnostic imaging/radiotherapy, laser Component
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1071-2026·2026-01-21
MRI systems recalled over ice that may block the magnet venting system
Canon Medical Systems is recalling 34 Vantage Galan 3T MRI systems because ice may form in the venting system, and a quench in that condition could rupture the helium vessel.
Product
Allura Xper FD20 Biplane; Model Number: 722013;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1047-2026·2026-01-21
Motrin dispensers recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Motrin 2's dispensers over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
MAXXUS, System, Tomography, Computed, Emission
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1078-2026·2026-01-21
Oncology information system recalled over a potential for overtreatment
Elekta is recalling a MOSAIQ Oncology Information System with Particle Therapy License because a specific sequence can result in a partial treatment being delivered twice.
Product
MOSAIQ Oncology Information System with Particle Therapy License (License Kit 45700000000IQRO)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1024-2026·2026-01-21
Pepto Bismol recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Pepto Bismol over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
MAVERICK¿ Measurement Module Spectrometer PN 820-01367 (originally part of a kit PN 820-01519) Finished Goods PN 820-01496
Category
Drug
Distribution
0 states
HighFDA (Devices)·Z-1079-2026·2026-01-21
Azurion interventional systems recalled over nine identified software issues
Philips Medical Systems Nederland is recalling 990 Azurion R3.0 systems over nine identified software issues, including loss of X-ray after a pedal tap and continuous restart.
Product
Philips Azurion Systems R3.0. Includes the following label descriptions and corresponding models: 1. Azurion 3 M12. Model Number: 722229. 2. Azurion 3 M15. Model Number: 722230. 3. Azurion 5 M12. Model Number: 722231. 4. Azurion 5 M20. Model Number: 722232. 5.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1084-2026·2026-01-21
Lucky Ice mouthwash recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Lucky Ice Cool Mouthwash over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
Asserachrom HPIA. Model/Catalog Number: 00615. The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated during the type II heparin-induced thrombocytopenia (HIT type II) by ELISA.
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1018-2026·2026-01-21
MRI systems recalled over ice that may block magnet venting
Canon Medical Systems is recalling 22 Vantage Titan 3T MRI systems because ice in the magnet venting system could lead to a helium vessel rupture during a quench.
Product
VANTAGE TITAN 3T Model MRT-3010/MEXL-3010
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1096-2026·2026-01-21
Surgical access port kits recalled over trays that may crack
Intuitive Surgical is recalling 41,526 da Vinci SP Access Port Kits because the Access Port System tray may develop cracks, potentially resulting in a sterility breach.
Product
da Vinci SP, SP Access Port Kit, Large Incision Reference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-1058-2026·2026-01-21
Children's NyQuil recalled over insanitary conditions at a distribution center
Gold Star Distribution is recalling Children's NyQuil Cold & Flu over CGMP deviations, citing insanitary conditions including rodent exposure and activity at its distribution center.
Product
Medline Kits containing B. Braun IV Administration Sets and Pump Administration Sets, labeled as: 1) ADMIN KIT, Medline kit SKU DYKS1339B; 2) ADMIN KIT, Medline kit SKU DYKS1339C; 3) QCASC WELCOME KIT, Medline kit SKU DYKS1359B; 4) ADMISSION KIT, Medline kit SKU DYKS
Category
Drug
Distribution
Distributed nationwide

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1451–1475 of 27346