HighFDA (Devices)·Z-0733-2026·2025-12-10
[pending] Illegally Marketed
Pending LLM rewrite. Source: FDA_DEVICE Z-0733-2026.
- Product
- Illegally Marketed
- Category
- Medical Device
- Distribution
- Distributed nationwide
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.
Filters
Minimum severity
1451–1475 of 13463
- HighFDA (Devices)·Z-0854-2026·2025-12-10
[pending] IntelliVue MP50. Product Number: M8004A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0854-2026.
- Product
- IntelliVue MP50. Product Number: M8004A.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0756-2026·2025-12-10
[pending] Vitamin D-Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0756-2026.
- Product
- Vitamin D-Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0755-2026·2025-12-10
[pending] Vaginal PH Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0755-2026.
- Product
- Vaginal PH Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0807-2026·2025-12-10
[pending] Food Intolerance Test Medium
Pending LLM rewrite. Source: FDA_DEVICE Z-0807-2026.
- Product
- Food Intolerance Test Medium
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0734-2026·2025-12-10
[pending] Drug Test Small (4 substances)
Pending LLM rewrite. Source: FDA_DEVICE Z-0734-2026.
- Product
- Drug Test Small (4 substances)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0777-2026·2025-12-10
[pending] Fructose Intolerance Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0777-2026.
- Product
- Fructose Intolerance Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0790-2026·2025-12-10
[pending] Neurotransmitters Plus
Pending LLM rewrite. Source: FDA_DEVICE Z-0790-2026.
- Product
- Neurotransmitters Plus
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0726-2026·2025-12-10
[pending] Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrilla
Pending LLM rewrite. Source: FDA_DEVICE Z-0726-2026.
- Product
- Aurora EV-ICD and Clinical EV-ICD, single chamber, extravascular implantable cardioverter defibrillators (ICD), Product Number DVEA3E4
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0728-2026·2025-12-10
[pending] Blood Type Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0728-2026.
- Product
- Blood Type Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0743-2026·2025-12-10
[pending] Lyme Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0743-2026.
- Product
- Lyme Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0741-2026·2025-12-10
[pending] HPV Antigen Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0741-2026.
- Product
- HPV Antigen Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0796-2026·2025-12-10
[pending] SIBO Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0796-2026.
- Product
- SIBO Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0757-2026·2025-12-10
[pending] Sperm Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0757-2026.
- Product
- Sperm Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0771-2026·2025-12-10
[pending] Cholesterol Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0771-2026.
- Product
- Cholesterol Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0866-2026·2025-12-10
[pending] IntelliVue Patient Monitor MX600. Product Number: 865242.
Pending LLM rewrite. Source: FDA_DEVICE Z-0866-2026.
- Product
- IntelliVue Patient Monitor MX600. Product Number: 865242.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0855-2026·2025-12-10
[pending] IntelliVue MP60. Product Number: M8005A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0855-2026.
- Product
- IntelliVue MP60. Product Number: M8005A.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0754-2026·2025-12-10
[pending] Urinary Tract Infection Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0754-2026.
- Product
- Urinary Tract Infection Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0797-2026·2025-12-10
[pending] Sorbitol Intolerance Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0797-2026.
- Product
- Sorbitol Intolerance Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0730-2026·2025-12-10
[pending] Chlamydia Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0730-2026.
- Product
- Chlamydia Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0745-2026·2025-12-10
[pending] MPOX Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0745-2026.
- Product
- MPOX Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0806-2026·2025-12-10
[pending] Food Intolerance Test Large
Pending LLM rewrite. Source: FDA_DEVICE Z-0806-2026.
- Product
- Food Intolerance Test Large
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0770-2026·2025-12-10
[pending] Continuous Glucose Monitor (CGM)
Pending LLM rewrite. Source: FDA_DEVICE Z-0770-2026.
- Product
- Continuous Glucose Monitor (CGM)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0776-2026·2025-12-10
[pending] DHEA Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0776-2026.
- Product
- DHEA Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0804-2026·2025-12-10
[pending] Allergy test Small
Pending LLM rewrite. Source: FDA_DEVICE Z-0804-2026.
- Product
- Allergy test Small
- Category
- Medical Device
- Distribution
- Distributed nationwide