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
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
3376–3400 of 30780
- 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-0788-2026·2025-12-10
[pending] Men s Hormone Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0788-2026.
- Product
- Men s Hormone Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0746-2026·2025-12-10
[pending] Mycoplasma test, IgG and IgM
Pending LLM rewrite. Source: FDA_DEVICE Z-0746-2026.
- Product
- Mycoplasma test, IgG and IgM
- 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-0762-2026·2025-12-10
[pending] Food Sensitivity Test Small
Pending LLM rewrite. Source: FDA_DEVICE Z-0762-2026.
- Product
- Food Sensitivity Test Small
- 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-0800-2026·2025-12-10
[pending] Kidney Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0800-2026.
- Product
- Kidney 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-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-0809-2026·2025-12-10
[pending] Heavy Metals Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0809-2026.
- Product
- Heavy Metals Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0758-2026·2025-12-10
[pending] Environmental Pollutants Profile Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0758-2026.
- Product
- Environmental Pollutants Profile Test
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0859-2026·2025-12-10
[pending] IntelliVue Multi Measurement Server X2. Product Number: M3002A.
Pending LLM rewrite. Source: FDA_DEVICE Z-0859-2026.
- Product
- IntelliVue Multi Measurement Server X2. Product Number: M3002A.
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0783-2026·2025-12-10
[pending] Hair Mineral Analysis
Pending LLM rewrite. Source: FDA_DEVICE Z-0783-2026.
- Product
- Hair Mineral Analysis
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Food)·H-0219-2026·2025-12-10
[pending] Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar che
Pending LLM rewrite. Source: FDA_FOOD H-0219-2026.
- Product
- Pizza style shredded cheese blend (containing low-moisture part-skim mozzarella and mild cheddar cheeses), individually packaged in a plastic bag as: 1) Econo Pizza - Shredded, 8 oz., UPC 893800297, 12/case 2) Food Club Pizza Style Two Cheese Blend - Finely Shredded, 8 oz., UPC
- Category
- Food
- Distribution
- 31 states
- HighFDA (Devices)·Z-0873-2026·2025-12-10
[pending] Olympus OER-Pro
Pending LLM rewrite. Source: FDA_DEVICE Z-0873-2026.
- Product
- Olympus OER-Pro
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0747-2026·2025-12-10
[pending] Ovulation Test (5 tests)
Pending LLM rewrite. Source: FDA_DEVICE Z-0747-2026.
- Product
- Ovulation Test (5 tests)
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Drugs)·D-0203-2026·2025-12-10
[pending] SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
Pending LLM rewrite. Source: FDA_DRUG D-0203-2026.
- Product
- SALINE ENEMA — SALINE ENEMA (SODIUM PHOSPHATE MONOBASIC, SODIUM PHOSPHATE DIBASIC)
- Category
- Drug
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0763-2026·2025-12-10
[pending] GI Microbiome Profile Small
Pending LLM rewrite. Source: FDA_DEVICE Z-0763-2026.
- Product
- GI Microbiome Profile Small
- Category
- Medical Device
- Distribution
- Distributed nationwide
- HighFDA (Devices)·Z-0751-2026·2025-12-10
[pending] Syphilis Test
Pending LLM rewrite. Source: FDA_DEVICE Z-0751-2026.
- Product
- Syphilis 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-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-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 (Drugs)·D-0201-2026·2025-12-10
[pending] Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Or
Pending LLM rewrite. Source: FDA_DRUG D-0201-2026.
- Product
- Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
- Category
- Drug
- Distribution
- Distributed nationwide