HighFDA (Devices)·Z-0778-2026·2025-12-10
[pending] Gut Microbiome Test Large
Pending LLM rewrite. Source: FDA_DEVICE Z-0778-2026.
- Product
- Gut Microbiome Test Large
- 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
3176–3200 of 27093
- HighFDA (Devices)·Z-0791-2026·2025-12-10
[pending] Neurotransmitters XL
Pending LLM rewrite. Source: FDA_DEVICE Z-0791-2026.
- Product
- Neurotransmitters XL
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0760-2026·2025-12-10
[pending] Food Sensitivity Test Large
Pending LLM rewrite. Source: FDA_DEVICE Z-0760-2026.
- Product
- Food Sensitivity Test Large
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0779-2026·2025-12-10
[pending] Gut Microbiome Test Medium
Pending LLM rewrite. Source: FDA_DEVICE Z-0779-2026.
- Product
- Gut Microbiome Test Medium
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0727-2026·2025-12-10
[pending] Alcohol (ALC) Test Saliva
Pending LLM rewrite. Source: FDA_DEVICE Z-0727-2026.
- Product
- Alcohol (ALC) Test Saliva
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0789-2026·2025-12-10
[pending] Neurotransmitters Basic
Pending LLM rewrite. Source: FDA_DEVICE Z-0789-2026.
- Product
- Neurotransmitters Basic
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0794-2026·2025-12-10
[pending] Peptic Ulcer Test (H, pylori)
Pending LLM rewrite. Source: FDA_DEVICE Z-0794-2026.
- Product
- Peptic Ulcer Test (H, pylori)
- 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-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 (Food)·H-0234-2026·2025-12-10
[pending] Sonex brand aluminum pot; ISO 9001:2000; Made in Pakistan
Pending LLM rewrite. Source: FDA_FOOD H-0234-2026.
- Product
- Sonex brand aluminum pot; ISO 9001:2000; Made in Pakistan
- Category
- Food
- Distribution
- 1 state
- 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-0852-2026·2025-12-10
[pending] IntelliVue MP30. Product Number: M8002A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0852-2026.
- Product
- IntelliVue MP30. Product Number: M8002A.
- 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
- HighFDA (Devices)·Z-0878-2026·2025-12-10
[pending] MAMMOMAT Inspiration;
Pending LLM rewrite. Source: FDA_DEVICE Z-0878-2026.
- Product
- MAMMOMAT Inspiration;
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0731-2026·2025-12-10
[pending] D-Dimer Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0731-2026.
- Product
- D-Dimer Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0810-2026·2025-12-10
[pending] Iodine Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0810-2026.
- Product
- Iodine 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 (Drugs)·D-0216-2026·2025-12-10
[pending] DULOXETINE (DULOXETINE HYDROCHLORIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0216-2026.
- Product
- DULOXETINE — DULOXETINE (DULOXETINE HYDROCHLORIDE)
- Category
- Drug
- 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 (Drugs)·D-0207-2026·2025-12-10
[pending] DYNASHIELD (ZINC OXIDE)
Pending LLM rewrite. Source: FDA_DRUG D-0207-2026.
- Product
- DYNASHIELD — DYNASHIELD (ZINC OXIDE)
- Category
- Drug
- 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-0884-2026·2025-12-10
[pending] Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Out
Pending LLM rewrite. Source: FDA_DEVICE Z-0884-2026.
- Product
- Reagent Kits/ containing flow cells, components of NextSeq 550Dx Instrument: NextSeq 550Dx High Output Reagent Kit v2.5 (75 cycles) IVD, REF: 20028870/NextSeq 550Dx HO FC Cart v2.5, 75 Cycles, REF: 20031098; NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD, REF: 2002
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0864-2026·2025-12-10
[pending] IntelliVue Patient Monitor MX500. Product Number: 866064.
Pending LLM rewrite. Source: FDA_DEVICE Z-0864-2026.
- Product
- IntelliVue Patient Monitor MX500. Product Number: 866064.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0766-2026·2025-12-10
[pending] NAD Profile Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0766-2026.
- Product
- NAD Profile Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0798-2026·2025-12-10
[pending] Women s Hormone Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0798-2026.
- Product
- Women s Hormone Test
- Category
- Medical Device
- Distribution
- Distributed nationwide