[pending] GEM Premier 5000 PAK; Part No. 00055407508.
Pending LLM rewrite. Source: FDA_DEVICE Z-1529-2026.
- Product
- GEM Premier 5000 PAK; Part No. 00055407508.
- Category
- Medical Device
- Distribution
- Distributed nationwide
Severity 3 of 5
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.
The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.
Pending LLM rewrite. Source: FDA_DEVICE Z-1529-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1554-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1508-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1558-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1526-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1510-2026.
House of Flavors 4893 Chicago Vanilla Naturally Flavored Ice Cream (3 gallon tubs) is being recalled because it contains undeclared egg, a common allergen. The recall affects 4,880 tubs distributed in Illinois.
Pending LLM rewrite. Source: FDA_DEVICE Z-1515-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1559-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1541-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1503-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1550-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1513-2026.
Coco's Italian Market Cannoli Making Kit is recalled because the label lists flour and ricotta cheese as sub-ingredients but fails to declare wheat and milk allergens. Consumers with wheat or milk allergies may be at risk if they consume the product.
Pending LLM rewrite. Source: FDA_DEVICE Z-1496-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1548-2026.
CNC Noodle Corporation is recalling ZHONG HUA CHAO MIAN fresh noodles due to undeclared wheat and Yellow #6 food coloring on the label. Consumers with wheat allergies or sensitivities to the colorant may be at risk.
Pending LLM rewrite. Source: FDA_DEVICE Z-1507-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1524-2026.
Willamette Valley Pie Company is recalling Frozen Raw Bulk 9 inch Blueberry Crumble Pie due to potential contamination with listeria monocytogenes. The frozen pies were sold to grocery retailers' in-store bakeries in Illinois and Oregon.
Palmetto Gourmet Foods Inc. is recalling Vegetarian Chicken Flavor Ramen Express because the product contains undeclared Yellow #5 food coloring, a major allergen for some consumers.
Pending LLM rewrite. Source: FDA_DRUG D-0400-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1509-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1542-2026.
Pending LLM rewrite. Source: FDA_DEVICE Z-1498-2026.