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.
A batch of I.B.S compression screws may have incorrect dimensions compared to their labels due to a batch mix-up. The 59 affected units were distributed nationwide in Tennessee.
Angiodynamics is recalling 58 units of its MINI STICK MAX guidewire introducer due to voids in the internal lumen that may prevent proper guidewire passage. Users may experience procedural delay requiring device exchange.
Siemens is recalling its DCA HbA1c Reagent Kit because the device displays falsely elevated readings without alerting the user. This could lead to incorrect patient management of glucose levels.
A vascular guidewire introducer is recalled because internal voids in the hub may prevent proper guidewire passage, potentially delaying surgical procedures.
Novitium Pharma LLC recalls Digoxin 125mcg tablets nationwide due to cross contamination with mycophenolate mofetil, a different medication. Patients receiving contaminated tablets could experience unintended drug effects.
Baxter Healthcare is recalling HDS Traction Boot II units due to incorrect assembly. The boot key socket locking ridge faces upward, preventing proper attachment to the traction system.
Eugia US LLC is recalling Nicardipine Hydrochloride Injection nationwide due to failed impurity specifications. The 335,940 affected vials contain organic impurities exceeding acceptable standards.
Angiodynamics is recalling MINI STICK MAX guidewire introducers (155 units) due to manufacturing defects in the sheath hub that may prevent guidewire passage.
Beckman Coulter recalls Access Total T4 thyroxine assay due to imprecision that may cause erroneous or delayed diagnostic results.
Dole Fresh Vegetables Inc is recalling Dole Premium Kit Endless Summer salad kits due to potential Listeria monocytogenes contamination. Affected products have specific production codes dated February 2024.
A Class II medical device recall has been issued for Directional Laser Probes due to potential difficulties extending, retracting, and directing the laser fiber tip. The issue affects 126 units distributed across multiple US states.
Hikma Pharmaceuticals is recalling Infumorph 200 (morphine sulfate) ampuls because the sterile filter in the carton has an earlier expiration date than the medication, potentially compromising sterility.
D.O.R.C. recalls 78 directional laser probes with Alcon/Lumenis connectors due to difficulties extending, retracting, or directing the laser fiber. The Class II recall affects units distributed across multiple U.S. states and Puerto Rico.
Albertsons is recalling Signature Select, Athens, and Cal Pia brand Bread Butter White Bread due to possible metal and plastic shavings in the product. The recall affects approximately 13,550 units distributed in California and Nevada.
Bob Evans Original Mashed Potatoes (2 lbs) with UPC 75900005349 from batch KCL1 are being recalled due to potential red plastic contamination. No illnesses have been reported.
ConvaTec is recalling specific lots of EsteemBody Soft Convex Drainable Pouches due to inconsistency in filter weld strength, affecting 6709 units distributed in the US and internationally.
El Chilar ground cinnamon (1.25 oz bags) is being recalled due to elevated levels of lead. Affected products were distributed in Maryland; consumers should not use them.
Covidien is recalling Situate Laparotomy Sponges because some packs may contain improperly sterilized units lacking required RF detection features. Non-sterile sponges could cause infection, tissue trauma, and sepsis during surgery.
Eugia US LLC is recalling 43,920 vials of Nicardipine Hydrochloride Injection nationwide due to failure to meet organic impurity specifications. No illnesses have been reported.
Angiodynamics recalls the MINI STICK MAX vascular guidewire introducer due to internal defects in the sheath hub that may prevent guidewire insertion during surgery, potentially requiring equipment exchange.
Preat Corp is recalling 561 units of RP Titanium Abutment Blanks due to a manufacturing defect where the screw seat location may be too high, resulting in shortened screw engagement into the implant.
Mc3 Inc recalls Nautilus ECMO Oxygenator units due to heat exchanger water path restriction that degrades temperature control performance. Inadequate heat transfer may lead to hypothermia risk.
Ethos Bakery is recalling Vegan Pecan Oat Scones distributed in Washington because the product label fails to declare wheat as an allergen, despite wheat flour being present in the product.
Curaplex Nasal Intubation Kit recalled because the included endotracheal tube holder is incompatible with nasal intubation procedures, preventing practitioners from properly securing the tube.
A precision component in Think Surgical's TMINI robotic knee system may bind due to insufficient clearance. The binding could occur during surgical drilling.