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.
Hill-Rom is recalling 3,556 SlingBar 350 patient lifting devices because a retrospective review found four units may present a potential for impalement if a person falls onto the hooks.
Cordis is recalling 1,357 FLEXSTENT Biliary Self-Expanding Stent Systems because holes or tears can form in the inner or outer pouches.
Hill-Rom is recalling 726 SlingBar Standard units because a retrospective review found a potential for impalement if a person falls onto the hooks.
AGFA Corp. is recalling 104 DX-D 100 digital radiography systems because they may experience intermittent, unintended, and illogical movement during use.
Combi USA is recalling specific child seats because the harness webbing fails to meet minimum breaking strength requirements, increasing injury risk in crashes.
PACCAR is recalling 2013-2014 Kenworth T440 trucks because the entry step tread plate is misaligned, creating a slip hazard.
Mitsubishi is recalling replacement lithium-ion batteries for 2012 i-MiEV vehicles due to internal contamination that may cause reduced voltage or short-circuits.
Adobe is recalling high-powered magnets distributed in a promotional package due to the risk of serious internal injury if swallowed by children.
Kuryakyn is recalling specific motorcycle backrests because pivot screws may loosen, causing the backrest to separate and potentially leading to loss of control.
Gerber is recalling Bear Grylls Parang Machetes with stitched sheaths because the blade can cut through the stitching, posing a laceration hazard.
Philips is recalling about 8,100 metal halide lamps because internal wiring can arc, posing fire and laceration risks. Consumers should stop using them and contact Philips for a refund or replacement.
IKEA is recalling LYDA jumbo coffee and tea cups because they can break when hot liquid is poured into them, posing a burn hazard.
Country Life LLC is recalling Target-Mins Iron Supplement Bottles because the packaging is not child-resistant, posing a risk of serious injury or death to young children.
Zimmer, Inc. is recalling 69 units of NEXGEN Complete Knee Solution Tibial Drills because the outside diameter may be oversized, preventing them from passing through the drill guide.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and the assurance of sterility.
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because the packaged micro Introducer may be the wrong French size.
Intuitive Surgical is recalling 8mm Precise Bipolar Forceps used with the da Vinci Surgical System because a component may dislodge, preventing proper cautery connection and causing loss of function.
Stryker Orthobiologics is recalling 17 units of the Aliquot Plunger, 8", due to reported catheter breakage during vertebroplasty procedures.
Nora Apothecary is recalling PHMB Ophthalmic Solution 0.02% because FDA inspections raised concerns about quality control and sterility assurance.
Nora Apothecary is recalling Trimix penile injections because FDA inspections raised concerns about quality control and sterility assurance.
Stryker Orthobiologics is recalling 12 units of the Aliquot Beveled Needle due to reported catheter breakage during vertebroplasty procedures.
Talenti Gelato is recalling 16 fl oz Roman Raspberry Sorbetto containers in Indiana due to undeclared pecans.
AngioDynamics is recalling Micro Introducer Kits because the packaged sheath or dilator may be the incorrect French size.
RaySearch Laboratories AB is recalling RayStation Therapy Treatment Planning System software versions 2.0, 2.5, and 3.0 because imported medical images may be offset by one pixel, potentially leading to incorrect dose calculations.
Ideations DiveAlert is recalling specific scuba signaling devices that may malfunction and restrict air flow, posing a drowning risk to divers.