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.
American Contract Systems Inc is recalling 144 CYSTO Model SACY80R kits due to inability to confirm sterilization requirements were met. Unsterilized devices may lose functionality and delay patient treatment.
The VERICIS Merge Cardio system may display inconsistent cardiovascular measurements in patient reports when specific workflows are used. This could affect clinical decisions based on the reported data.
Medline is recalling 880 medical convenience kits containing plastic syringes with potential leaks and breakage. The syringes were identified as defective and may pose health risks to patients.
American Contract Systems unable to confirm sterilization of 956 General Angio Pack kits distributed nationwide. Unsterile devices may lose functionality and delay patient treatment.
Chef's Line US Foods 3 Grain Slider buns are being recalled due to foreign material (a bolt) found in the product. Approximately 8,107 cases were distributed to IL, MD, NJ, PA, and DE.
Chef's Line US Foods black bean burgers are being recalled because a bolt was found in the product. The recalled product was distributed to Illinois, Maryland, New Jersey, Pennsylvania, and Delaware.
Microstream CO2 sampling lines and airway adapters may be difficult or impossible to disconnect from endotracheal tubes during clinical procedures, potentially causing treatment delays and unintended extubation with risk of serious complications.
Amgen recalls 258,750 vials of Neupogen (filgrastim) injection due to stability concerns. Stability data shows products may be out of specification at expiration; patients should consult healthcare providers about affected lots.
American Contract Systems Inc is recalling 106 SPINE LUMBAR PACK kits (Models UTSL72AA, UTSL72AB) because the manufacturer cannot confirm sterilization assurance requirements were met, potentially causing functionality loss and treatment delays.
Weight plates on FitRx SmartBell XL dumbbells can dislodge during use, causing impact injuries. More than 60 incidents reported, linked to 7 documented injuries including bruises and contusions.
GIKPAL 10 Drawer Dressers sold on Walmart.com are recalled for tip-over and entrapment hazards to children if not anchored to a wall. About 28,590 units were sold between September 2023 and January 2025.
Arsell is recalling Benadryl Liquid Elixir 100 mL bottles sold on Amazon because the packaging is not child-resistant as required by federal law. The medication could poison children if ingested.
VC Group recalls 89,500 MagSafe wireless power banks because lithium-ion batteries can overheat and ignite. The company received 19 fire reports resulting in 10 minor injuries.
Reckitt is recalling approximately 16,200 bottles of Woolite Delicates detergent sold exclusively on Amazon due to potential Pseudomonas bacteria contamination. The bacteria poses a serious infection risk to people with weakened immune systems or external medical devices.
Kimpex ski kits for snowmobiles can detach from the vehicle, posing a crash hazard and risk of serious injury. No injuries have been reported to date.
ZOLL is recalling certain Powerheart G5 AED units that may fail their self-test when exposed to extreme temperatures or humidity. The affected devices could fail to function properly in emergencies.
GE Healthcare Revolution CT and Apex series imaging systems may leak blue coolant fluid near the gantry base, creating a potential slip and fall hazard. Approximately 250 units have been distributed worldwide.
Chattem Inc. is recalling Unisom SleepMelts diphenhydramine HCl 25 mg tablets nationwide due to a nitrosamine impurity detected above FDA's acceptable daily intake limit. Affected lots expire between May 2025 and April 2026.
Stiebs, LLC is recalling Organic Acai Bowls due to potential contamination with blue plastic pieces. Affected products were distributed in six states.
ZOLL is recalling certain Powerheart G5 automated external defibrillators (AED) due to the potential for devices to fail their self-test when exposed to extreme temperatures or humidity.
HEB is recalling Spinach Artichoke Dip sold in Texas due to potential metal contamination. Consumers should not consume the affected products.
Aesculap is recalling 1,147 hemostatic forceps due to clamp breakage risk when used beyond design specifications. Units were distributed nationwide and internationally to healthcare providers.
Chicken of the Sea is recalling 14,147 cases of Van Camp's Solid Light Yellowfin Tuna due to improperly secured easy-pull lids that may allow Clostridium botulinum contamination. No illnesses have been reported.
CardioFocus is recalling 833 units of CardiFocus Heartlight X3 cardiac catheters due to potential damage to the sterile barrier pouch that could compromise product sterility. Affected units were distributed worldwide.
ZOLL is recalling Powerheart G5 AED devices that may fail their self-test when exposed to extreme temperature or humidity, potentially affecting proper device operation.