HighFDA (Devices)·Z-0759-2026·2025-12-10
[pending] Food Allergy Panel Test (IgE)
Pending LLM rewrite. Source: FDA_DEVICE Z-0759-2026.
- Product
- Food Allergy Panel Test (IgE)
- 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
1426–1450 of 13463
- 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-0795-2026·2025-12-10
[pending] PSA Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0795-2026.
- Product
- PSA Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0725-2026·2025-12-10
[pending] InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack
Pending LLM rewrite. Source: FDA_DEVICE Z-0725-2026.
- Product
- InSure ONE Fecal Immunochemical Test. Labeled as follows: 1. Insure ONE POL Patient Kit - 10 pack. Model Number: 90010. 2. Insure ONE POL Patient Kit - 25 Pack. Model Number: 90025. 3. InSure ONE POL Combo Pack. Model Number: 90030. InSure ONE is a fecal immunochemica
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0787-2026·2025-12-10
[pending] Leaky Gut Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0787-2026.
- Product
- Leaky Gut Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0742-2026·2025-12-10
[pending] Iron Deficiency Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0742-2026.
- Product
- Iron Deficiency Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0848-2026·2025-12-10
[pending] Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Pending LLM rewrite. Source: FDA_DEVICE Z-0848-2026.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0772-2026·2025-12-10
[pending] Adrenal Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0772-2026.
- Product
- Adrenal Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0768-2026·2025-12-10
[pending] Vitamin D2 and D3 Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0768-2026.
- Product
- Vitamin D2 and D3 Test
- 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-0815-2026·2025-12-10
[pending] Serotonin Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0815-2026.
- Product
- Serotonin Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0865-2026·2025-12-10
[pending] IntelliVue Patient Monitor MX550. Product Number: 866066.
Pending LLM rewrite. Source: FDA_DEVICE Z-0865-2026.
- Product
- IntelliVue Patient Monitor MX550. Product Number: 866066.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- 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
- HighFDA (Devices)·Z-0850-2026·2025-12-10
[pending] IntelliVue MP5. Product Number: M8105A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0850-2026.
- Product
- IntelliVue MP5. Product Number: M8105A.
- 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-0851-2026·2025-12-10
[pending] IntelliVue MP20. Product Number: M8001A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0851-2026.
- Product
- IntelliVue MP20. Product Number: M8001A.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0867-2026·2025-12-10
[pending] IntelliVue Patient Monitor MX700. Product Number: 865241.
Pending LLM rewrite. Source: FDA_DEVICE Z-0867-2026.
- Product
- IntelliVue Patient Monitor MX700. Product Number: 865241.
- 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-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-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-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-0876-2026·2025-12-10
[pending] KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, C
Pending LLM rewrite. Source: FDA_DEVICE Z-0876-2026.
- Product
- KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
- Category
- Medical Device
- Distribution
- 0 states
- HighFDA (Devices)·Z-0814-2026·2025-12-10
[pending] Pollen Allergy Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0814-2026.
- Product
- Pollen Allergy Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0780-2026·2025-12-10
[pending] Gut Microbiome Test Mega
Pending LLM rewrite. Source: FDA_DEVICE Z-0780-2026.
- Product
- Gut Microbiome Test Mega
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0858-2026·2025-12-10
[pending] IntelliVue MP90. Product Number: M8010A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0858-2026.
- Product
- IntelliVue MP90. Product Number: M8010A.
- Category
- Medical Device
- Distribution
- Distributed nationwide