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.
Medline is recalling CV Neonatal Pack procedure kits (Pack Number DYNJ67356) because the plastic syringes may leak or break, potentially harming patients. The recall affects 96 units distributed nationwide and in Canada.
Medline Industries recalls 3,860 surgical procedure kits with defective plastic syringes that may leak or break during use. The affected kits are distributed in the US and Canada.
Medline procedure kits containing plastic syringes are being recalled due to leaks, breakage, and quality issues that may compromise sterile medical procedures. Approximately 14,589 units were distributed nationwide in the US and Canada.
Baxter Healthcare is recalling 93 TruSystem 7500 Hybrid Plus units for a software issue that renders the upper back section inoperable when emergency mode is enabled.
Medline Industries is recalling 1,711 procedure kits containing plastic syringes affected by manufacturing defects. The syringes may leak or break, posing a risk to patient safety during medical procedures.
Medline is recalling certain arterial pressure monitoring line kits due to excess material on female luer fittings. The affected kits were distributed worldwide, including the United States.
Baxter is recalling 2 units of TruSystem 7500 Hybrid (MC) due to a software issue that disables the upper back section adjustment when emergency mode is activated.
American Contract Systems is recalling 500 Lap Pack - 170307 convenience kits distributed in Arizona due to sterility assurance concerns with procedure trays.
Premier Dental Products Co is recalling Premier Solo Diamond Large dental burs because the material hardness does not meet specifications and may cause the burs to bend during use. 77 units in six U.S. states are affected.
Medline is recalling angiography and catheterization procedure kits containing plastic syringes that may leak or break. The recalled kits affect 1939 units distributed nationwide and in Canada.
Medline is recalling 4400 Namic convenience kits with Pressure Monitoring Lines because the female luer fittings were manufactured with excess material near the fluid pathway.
Medline is recalling 808 medical procedure kits containing plastic syringes with quality defects that may leak or break during use. Affected customers should stop using these kits and contact Medline for replacement instructions.
Baxter is recalling 48 TruSystem 7500 Hybrid Plus units due to a software issue that prevents the upper back section from being adjusted when emergency mode is enabled.
Medline Industries has recalled 11,774 surgical procedure kits with defective plastic syringes that may leak or break. The kits were distributed nationwide and in Canada.
American Contract Systems recalls 460 Cardiac Cath Lab Pack kits due to sterility assurance issues with procedure trays. Facilities should verify affected lots have been removed from clinical use.
Medline is recalling ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters used in cardiac procedures because the devices may contain higher than expected levels of bacterial endotoxin.
Strides Pharma is recalling Testosterone Gel 1% (195,952 cartons nationwide) due to benzene contamination. Consumers using affected lots should immediately contact their healthcare provider.
Strides Pharma is recalling Testosterone Gel 1% nationwide due to the presence of benzene, a toxic substance. Patients should contact their healthcare provider about alternative treatment options.
Baxter Healthcare is recalling 149 NovumIQ syringe infusion pumps with incorrectly installed gaskets that could allow fluid ingress during cleaning or after IV fluid spills.
Medline procedure kits containing plastic syringes are recalled for leaks, breakage, and other quality defects identified in an FDA Safety Alert. The recall affects 340 units distributed nationwide in the US and Canada.
BMW is recalling certain 2025 BMW vehicles because the electrical connection between the starter-generator and battery may come loose, potentially causing engine stall or fire.
Volkswagen is recalling certain 2021 Audi A6, A7, A8, Q7, Q8, RS and S models because a software error may cause the instrument panel display to fail.
BMW is recalling 2024-2025 M 1000 R and M 1000 XR motorcycles because a loose valve pin in the steering damper may cause increased steering effort and loss of control.
APOTHEKE's Pumpkin Ginger 3-wick candles can overheat and break their glass containers, posing fire and burn hazards. About 640 units were sold at Crate & Barrel from June 2024 through January 2025.
Specialized Vado and Como IGH e-bikes have defective chain/belt guards that do not fully cover the belt drive, allowing loose clothing to become entrapped and cause falls. About 32,400 units were sold in the US.