Hazard
536 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.
Of the 536 regulatory non compliance recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 56 (10%) are Severe.
Which agencies issued them
Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all regulatory non compliance recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.
A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.
Adept Medical Ltd is recalling 13,070 Otological Ventilation Tubes because they were distributed without FDA 510(k) clearance. Over 9,000 units were distributed in the US and 3,980 internationally.
Adept Medical Ltd is recalling 310 units of Otological Ventilation Tubes (Product Code NZ3312-2) distributed in the US and internationally due to lack of FDA 510(k) regulatory clearance. The devices were distributed without required FDA pre-market approval.
Adept Medical Ltd is recalling 2,010 units of T-Tube 6mm Double Silicone otological ventilation tubes distributed without required FDA 510(k) clearance. The recall affects 630 US units and 1,380 international units.
Nihon Kohden America Inc. is recalling 64 Adult Ear Clip SpO2 Sensors (Model 809030007) due to lack of FDA market approval and clearance for U.S. distribution.
King Systems Corp. is recalling 31,457 units of King LTSD oropharyngeal airways because the device exceeded 510(k) exemption limitations by introducing a new pediatric indication.
King Systems Corp. dba Ambu, Inc. is recalling 42,605 units of King LTSD Oropharyngeal Airways due to exceeding 510(k) exemption limitations.
Blue Ortho is recalling 136 units of Predict+ software because it lacks FDA pre-market clearance or approval.
Sol-Millennium Medical Inc. recalls SOL-M eccentric tip syringes (10ml, 20ml, 60ml) worldwide due to substantial differences from FDA-cleared specifications and major modifications to intended use.
Sol-Millennium Medical Inc. is recalling certain Syringe Tip Cap models because they were modified without proper FDA clearance. The modified devices differ from their approved specifications.
Farmalac powdered infant formula was recalled because the manufacturer failed to submit required premarket notification to the FDA. The product was never evaluated for safety or nutritional standards.
Jiangsu Shenli is recalling Medline non-sterile 3mL syringes (Model 91820) nationwide because their configurations exceed FDA clearance scope. Users should discontinue use immediately.
Jiangsu Shenli Medical is recalling Wolf Medical 60 mL Luer Lock piston syringes because they were manufactured outside the scope of the firm's FDA 510(k) clearance.
Jiangsu Shenli Medical has recalled over 1 million Wolf Medical WOLF-PAK 1 mL disposable syringes because piston syringe sizes and configurations exceed those cleared under the company's 510(k) approval.
Medline 3-mL non-sterile syringes are being recalled because their actual sizes and configurations fall outside the FDA-approved range for the manufacturer's 510(k) clearance. 20,000 units were distributed nationwide across six U.S. states.
Jiangsu Shenli Medical is recalling MEDLINE non-sterile 5ML syringes (Model 91826) because certain sizes and configurations exceed the range cleared by the FDA. The company is notifying customers and arranging product retrieval.
Medline non-sterile syringes are being recalled because configurations and sizes sold exceeded the FDA's approved 510(k) scope. Approximately 502,250 units were distributed nationwide.
The FDA is recalling 98,700 GMAX non-sterile syringes (Model TS2212L-M) because their sizes and configurations exceed FDA-cleared specifications. Affected units were distributed in California, Florida, Georgia, Illinois, Tennessee, and Virginia.
Jiangsu Shenli Medical Production Co. recalls approximately 30,800 non-sterile Medline 10mL syringes because their sizes and configurations fall outside FDA-cleared scope. No injuries reported.
GMAX SYR 20ML/LS non-sterile syringes do not meet FDA-cleared specifications. The recall affects approximately 62,000 units distributed nationwide across 14 lot codes.
Jiangsu Shenli Medical Production is recalling approximately 724,500 Wolf Medical 12 mL syringes because the product configurations exceed the scope of FDA clearance. Units distributed nationwide should be returned.
Jiangsu Shenli Medical has recalled Medline non-sterile syringes because manufactured sizes and configurations exceed the FDA-cleared scope. No illnesses or injuries have been reported.
Jiangsu Shenli Medical Production Co. is recalling GMAX SYR 60ML/LL blue syringes because the manufactured sizes and configurations fall outside the range cleared by the FDA. Approximately 116,160 units were distributed nationwide.
Medline non-sterile syringes (Model 91876) are being recalled because certain lot codes contain sizes and configurations that exceed the range cleared by the FDA. No injuries or illnesses have been reported.
GMAX SYR 30ML/LL syringes manufactured by Jiangsu Shenli Medical have been recalled because their sizes and configurations exceed the FDA 510(k) specifications approved for these devices. The recall affects 1,117,500 units distributed nationwide.
FDA recalls 60,000 GMAX SYR 5ML/LL non-sterile syringes manufactured by Jiangsu Shenli Medical Production because the piston syringe sizes and configurations were not cleared under the firm's FDA 510(k) application.