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

51–75 of 113671

HighFDA (Devices)·Z-3028-2026·2026-09-02
Medline Recalls 419 Surgical Kits Due to Contaminated Component
Medline Industries is recalling 419 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide.
Product
Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54362F; 2) EAST MAJOR LITHOTOMY, Medline Kit SKU DYNJ900957C; 3) GYN LAPAROTOMY, Medline Kit SKU DYNJ906804B; 4) UNIVERSAL GYN, Medline Kit SKU DYNJ910195A.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3020-2026·2026-09-02
Medline Recalls 263 Surgical Convenience Kits Due to Contamination
Medline Industries is recalling 263 surgical convenience kits because they contain a potentially contaminated component. The kits were distributed nationwide in 18 states.
Product
Medline convenience kits labeled as: 1) OPEN HEART PACK, Medline Kit SKU CDS840393P; 2) OPEN HEART PACK, Medline Kit SKU CDS840393Q; 3) OPEN HEART PROCEDURE, Medline Kit SKU CDS980895W; 4) VALVE CDS, Medline Kit SKU CDS981551G; 5) FEM POP, Medline Kit SKU CDS982028W;
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3024-2026·2026-09-02
Medline Recalls 663 Surgical Convenience Kits Due to Contamination
Medline Industries is recalling 663 surgical convenience kits distributed nationwide because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) MAJOR GYN PACK, Medline Kit SKU DYNJG001030C; 2) GYN LITHOTOMY PACK, Medline Kit SKU DYNJT8166; 3) OPEN HEART PACK, Medline Kit SKU DYNJ47638B; 4) EAST DAVINCI, Medline Kit SKU DYNJ900949C; 5) THORACIC, Medline Kit SKU DYNJ903470
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3037-2026·2026-09-02
GE Medical Systems Recalls Portrait Compute and Core Services Software
GE Medical Systems is recalling 4 units of Portrait Compute and Core Services V1.2 software due to a defect that may cause loss of patient monitoring and reset alarm settings to factory defaults.
Product
PORTRAIT COMPUTE AND CORE SERVICES V1.2, Ref# 5700592
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-2995-2026·2026-09-02
Medline Medical Convenience Kits Recalled for Endotoxin Levels
Medline is recalling 246 surgical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
Product
Medline medical convenience kits, labeled as: 1) CRANIOTOMY PACK, Medline Kit SKU DYNJT6545; 2) ORTHO SPINE PACK, Medline Kit SKU DYNJ88056A; 3) ENT SINUS PACK, Medline Kit SKU DYNJ89001; 4) THYROID ENT, Medline Kit SKU DYNJ908641.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3029-2026·2026-09-02
Medline Recalls Neurosurgical Convenience Kits Due to Contamination
Medline Industries is recalling 241 neurosurgical convenience kits distributed nationwide because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) NON MB MJR NEURO CRANI SM PK, Medline Kit SKU DYNJT6104; 3) CRANIOTOMY, Medline Kit SKU DYNJ903471I; 4) KIT CRANIOTOMY RFD, Medline Kit SKU DYNJ906496K.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3033-2026·2026-09-02
IMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
IMRIS Imaging Inc is recalling six ORT200 operating room tables because a mechanical failure could cause unintended movement and patient injury.
Product
ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned, Part Number 113821-600 and the ORT200 50/60Hz Covered Table Assy V2 Part Number 114148-000
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Food)·H-1258-2026·2026-09-02
Sura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
Sun Noodle is recalling Sura Tanmen Hot and Sour Flavor ramen kits because the soup packet contains fish but the label does not declare it.
Product
Sura Tanmen Hot and Sour Flavor Premium Japanese Noodles & Soup Base. Retail package net wt. 15.4oz. Product is ramen noodle kit which contains noodles and Soba soup packet. Item #05410 retail package, UPC 085315054108 Item #05410.1 cardboard box (12 packages per case), UPC 085
Category
Food
Distribution
1 state
HighFDA (Devices)·Z-3004-2026·2026-09-02
Merge Healthcare Recalls PACS Workstations Due to Inaccurate Measurements
Merge Healthcare is recalling 20 Merge PACS and Merge OrthoPACS workstations because a software issue may cause measurements to be displayed inaccurately.
Product
Merge PACS and Merge OrthoPACS, medical imaging diagnostic workstation
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3038-2026·2026-09-02
GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
GE Medical Systems is recalling 15 units of Portrait Core Services Software V1.0.5 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
Product
PORTRAIT CORE SERVICES SOFTWARE V1.0.5, Ref# 5697353
Category
Medical Device
Distribution
2 states
HighFDA (Devices)·Z-3039-2026·2026-09-02
GE Medical Systems Recalls Portrait Core Services Software Reload Unit
GE Medical Systems is recalling a software reload unit for the Portrait Core Services system due to a defect that may cause loss of patient monitoring and reset alarm settings.
Product
FRU (Field replaceable unit), PORTRAIT CORE SERVICES SW RELOAD V1.1, Ref# 5700225
Category
Medical Device
Distribution
2 states
HighFDA (Drugs)·D-0775-2026·2026-09-02
Accord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 25 mcg tablets nationwide because they are subpotent.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3031-2026·2026-09-02
Healthmark ProChek-II Medical Tests Recalled for Expired Ingredient
Healthmark Industries is recalling ProChek-II tests because they were manufactured with an expired ingredient, which may cause false negative or positive results.
Product
healthmark ProChek-II, Model Number PT-313, PT-201-12
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0784-2026·2026-09-02
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium tablets because they may contain less active ingredient than labeled.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3014-2026·2026-09-02
Canon Medical Alphenix X-ray Systems Recalled for Loose Ceiling Screws
Canon Medical System, USA, INC. is recalling 10 Alphenix digital radiography systems because fixing screws in the ceiling suspended arm may become loose.
Product
Alphenix Models INFX-8000C INFX-8000F INFX-8000V This device is a digital radiography/fluoroscopy system used in a diagnostic and interventional angiography configuration. The system is indicated for use in diagnostic and angiographic procedures for blood vessels in the he
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0777-2026·2026-09-02
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is voluntarily recalling specific lots of Levothyroxine Sodium 75 mcg tablets nationwide because they may contain less than the labeled amount of active ingredient.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2988-2026·2026-09-02
Philips Incisive CT Recalled for Potential Failure to Trigger Clinical Scan
Philips is recalling Incisive CT scanners with specific software versions due to a potential failure to trigger clinical scans during bolus tracking.
Product
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3036-2026·2026-09-02
GE Medical Systems Recalls Portrait Core Services Software Due to Monitoring Loss
GE Medical Systems is recalling Portrait Core Services Software V1.1 because a software issue may cause loss of patient monitoring and reset alarm settings to factory defaults.
Product
PORTRAIT CORE SERVICES SOFTWARE V1.1, Ref# 5700209
Category
Medical Device
Distribution
2 states
HighFDA (Food)·H-1278-2026·2026-09-02
Byron White Herbal Supplement Recalled for Undeclared Walnut Allergen
Byron White Formulas is recalling its A-FNG Herbal Supplement because the label fails to declare walnuts in English, posing a risk to consumers with nut allergies.
Product
Byron White FORMULAS A-FNG Herbal Supplement 1.0 fl. oz./30 mL May Contain Nuts (Juglans nigra hull) Byron White Formulas Inc. 3315 Chanate Rd. Suite 1C Santa Rosa, CA 95404
Category
Food
Distribution
50 states
HighFDA (Devices)·Z-3023-2026·2026-09-02
Medline Convenience Kits Recalled for Potentially Contaminated Component
Medline Industries is recalling 15 convenience kits (SKU CDS980375M) due to a potentially contaminated component. The kits were distributed in 18 US states.
Product
Medline convenience kits labeled as: LTP CDS-LF, Medline kit SKU CDS980375M
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3025-2026·2026-09-02
Medline Recalls Gynecologic Robotic Surgery Kits Due to Contamination
Medline Industries is recalling 1,349 gynecologic robotic surgery kits nationwide because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) GYN ROBOTIC CDS, Medline Kit SKU CDS982888Q; 2) GYN ROBOTIC ADD ON PACK, Medline Kit SKU DYNJ43837D; 3) OH GYN/LAP ROBOT PACK, Medline Kit SKU DYNJ89759; 4) GYN LAPAROSCOPY PACK, Medline Kit SKU DYNJ89781; 5) ROBOT ME RF, Medline
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Drugs)·D-0782-2026·2026-09-02
Accord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
Accord Healthcare is recalling specific lots of Levothyroxine Sodium 137 mcg tablets because they may contain less than the labeled amount of active ingredient.
Product
LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
Category
Drug
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3019-2026·2026-09-02
Medline Recalls 71 Convenience Kits Due to Contaminated Component
Medline Industries is recalling 71 FEMORAL PACK and FEVAR convenience kits because they contain a potentially contaminated component.
Product
Medline convenience kits labeled as: 1) FEMORAL PACK, Medline Kit SKU DYNJ909393A; 2) FEVAR, Medline Kit SKU DYNJ910295D.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-3017-2026·2026-09-02
Fresenius BlueStar Hemodialysis Machines Recalled for Alarm Defects
Fresenius Medical Care is recalling 1,140 BlueStar Hemodialysis machines due to reported flow, water, or temperature-related alarms.
Product
Fresenius Medical Care, 2008T BlueStar Hemodialysis Machine, Model Numbers: 191126, 191130.
Category
Medical Device
Distribution
Distributed nationwide
HighFDA (Devices)·Z-2994-2026·2026-09-02
Medline Medical Convenience Kits Recalled for Endotoxin Levels
Medline Industries is recalling 2,262 medical convenience kits containing neurosponges due to potential out-of-specification endotoxin levels.
Product
Medline medical convenience kits, labeled as: 1) SINUS PACK-LF, Medline Kit SKU DYNJ0966146F; 2) ENT PACK, Medline Kit SKU DYNJ40154D; 3) ENT PACK, Medline Kit SKU DYNJ40154F; 4) ENT SCOPE PACK, Medline Kit SKU DYNJ44480D; 5) ENT NASAL ORAL PACK MOSES, Medline Kit SKU
Category
Medical Device
Distribution
Distributed nationwide

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51–75 of 113671