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.
Nutricia is recalling KetcoCal 4:1 LQ Unflavored sample kits due to incorrect product in packaging. A total of 283 kits distributed to the US and Canada expire December 10, 2023.
Zydus Pharmaceuticals is recalling Oxybutynin extended-release tablets due to failed dissolution testing. The tablets may not dissolve properly, potentially affecting drug efficacy.
Philips is recalling two units of its DigitalDiagnost C90 Release 3.1 radiographic imaging system due to potential failure of ceiling-mounted units, which could fall.
B. Braun Medical is recalling AMO ophthalmologic administration sets due to a manufacturing defect causing potential leakage. This may delay therapy and expose patients and healthcare workers to hazardous medication.
Philips DigitalDiagnost C90 Release 3 ceiling-mounted imaging system faces potential suspension failure risk. The FDA issued a Class II recall for nationwide-distributed Model 712025 due to risk of equipment falling.
Gills Onions recalls diced yellow onions due to potential Salmonella Thompson contamination. The recall affects multiple states and Canadian provinces.
Gills Onions, LLC is recalling Cross Valley Farms fresh slivered yellow onions due to potential Salmonella Thompson contamination. Distribution affected the United States and Canada.
Stryker Corporation is recalling 2,321 units of Disposable Spetzler-Malis Bipolar forceps due to an expiration date labeling error. The label incorrectly shows a 54-month shelf life when the actual shelf life is 36 months.
Philips is recalling 101 ProxiDiagnost N90 radiography and fluoroscopy systems due to potential failure of ceiling-mounted units, which could fall and cause injury.
Stryker Corporation is recalling 2,321 units of disposable bipolar forceps due to a labeling error. The product label shows a 54-month shelf life, but the actual shelf life is 36 months.
Edwards Lifesciences is recalling Fogarty Thru-Lumen Embolectomy Catheters that may deflate more slowly than normal, potentially affecting device function during vascular procedures.
Philips is recalling 33 DigitalDiagnost C90 radiographic imaging systems nationwide due to potential structural failure of ceiling-mounted units. Equipment may fall, creating injury risk.
B. Braun Medical is recalling 400 units of a 30ML burette assembly due to a manufacturing defect that may cause leakage, potentially delaying therapy and increasing bloodstream infection risk.
Magellan Diagnostics recalls LeadCare II Blood Lead Test Kits nationwide due to defective plastic caps on reagent tubes. A small percentage of caps may not seal properly, potentially leading to inaccurate test results.
Hinterland Dairy Farmstead Cheese French Onion + Chive (8oz packages, Lot 1670) distributed in Iowa may contain E. coli. The FDA issued a Class II recall; consumers should discard the product or return it to their retailer.
Philips is recalling 46 CombiDiagnost R90 radiography systems nationwide due to potential ceiling mount failure that could allow suspended units to fall, posing an injury risk.
Securitas Healthcare is recalling Arial Water Resistant Pendants (models 59360 and 2560-59360) due to premature battery depletion that may prevent emergency alarms from being received.
Two different RSP humeral socket insert devices were swapped during packaging at Encore Medical. This could result in surgeons receiving an incorrect device for shoulder surgery, potentially delaying the procedure.
Stryker Corporation is recalling certain Spetzler-Malis Bipolar forceps due to incorrect expiration dates on product labels. The labels indicate a 54-month shelf life, but the actual shelf life is 36 months.
Securitas Healthcare is recalling its Arial Water Resistant Pendant (Models 59362 and 2560-59362) due to premature battery depletion, which may prevent alarms from being received by the emergency call system.
Philips DigitalDiagnost C90 ceiling-mounted radiographic systems may fail and fall. FDA Class II recall affects 143 units nationwide; facilities should contact Philips.
Hinterland Dairy Inc is recalling its Happy Jack Monterey Jack Cheese because it may contain E. coli. The affected cheese was distributed in Iowa.
Dr. Reddy's Laboratories is recalling 1,656 bottles of Montelukast Sodium 10 mg tablets due to contamination with a foreign metoprolol tablet found in at least one bottle. Affected lots were distributed nationwide.
Hinterland Dairy Inc is recalling Jalapeno Happy Jack Monterey Jack cheese due to potential E. coli contamination. The affected product was distributed in Iowa.
CareFusion is recalling 133,727 units of the BD Alaris Syringe Module because the labeling lists compatible syringes that have not been validated for use with the infusion pump.