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.
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.
Carestream Health is recalling 2,402 DRX-Revolution Mobile X-Ray Systems due to potential electrical failure in the generator causing thermal overload. The system becomes inoperable and may produce loud noise, burnt smell, and smoke.
St. Jude Medical is recalling CardioMEMS Patient Electronic System (Model CM1100) because the power connector plug may become damaged and frayed if bent beyond 90 degrees. This could cause device malfunction or electrical hazard.
B. Braun is recalling FT1000S Fluid Transfer Sets due to a manufacturing defect that may cause leakage. This could delay therapy, increase infection risk, and expose healthcare workers to hazardous medication.
Gills Onions, LLC is recalling Cross Valley Farms slivered yellow onions due to potential Salmonella Thompson contamination. The recall affects 6,400 pounds distributed across the United States and Canada.
Olympus Corporation is recalling 1,687 units of the EVIS EXERA III Gastrointestinal Videoscope nationwide due to sterilization failures that may occur when devices are reprocessed without adequate drying time in the endoscope channel.
Abbott Laboratories has recalled Similac Probiotic Tri-Blend infant supplement packets due to regulatory violations: the product was marketed without FDA approval as a new drug and contains an unsafe food additive.
Philips is recalling 83 EPIQ diagnostic ultrasound systems that may display delayed instead of real-time images due to a software issue, potentially affecting diagnostic imaging quality.
Family Dollar is recalling 329,044 VERIQUICK pregnancy tests due to improper storage outside labeled temperature requirements. Affected units were sold at Family Dollar stores June-October 2023.
Ortho-Clinical Diagnostics is recalling VITROS Lipase Slides due to measurement abnormalities that could result in falsely low or elevated test results. This could delay diagnosis of acute pancreatitis or cause diagnostic confusion.
Philips X-ray imaging systems delivered to Puerto Rico are missing warning labels and Source-to-Skin Distance Spacers. These missing safety components could affect user safety during imaging procedures.
Philips is recalling 13 DigitalDiagnost 4 Chest/Emergency radiographic imaging units due to a potential for ceiling-mounted units to fail and fall, posing injury risk.
Hinterland Dairy Inc is recalling Farmstead Cheese Mango Habanero (8oz packages, Lot 1670) distributed in Iowa due to potential E. coli contamination. Consumers should dispose of the product.
B. Braun is recalling SA3000 intravenous adapters due to a manufacturing defect that may cause leakage. This could delay therapy, increase bloodstream infection risk, and expose patients and workers to hazardous medication.
Greenhead Lobster Products is recalling frozen and fresh ready-to-eat lobster meat that may be contaminated with Listeria monocytogenes. The recall affects multiple states.
Philips is recalling Zenition 50 & 70 surgical C-arm systems distributed to Puerto Rico, Guam, and the Virgin Islands due to missing warning labels and safety spacers. These missing components may compromise radiation safety during surgical use.
B. Braun Medical is recalling 12,800 units of TERUMO IV injection sets (Lot 0061753485) due to a manufacturing defect that may cause leakage, delaying therapy and increasing risk of bloodstream infection.
Family Dollar is recalling DENTEMP ONE STEP temporary dental fillings sold between June 2023 and October 2023 in 22 states because they were stored outside labeled temperature requirements, which may affect product performance.
Philips recalled surgical C-arm systems in US territories without required warning labels and missing the Source-to-Skin Distance Spacer. Facilities should contact Philips for instructions on obtaining missing components.
Amneal Pharmaceuticals is recalling Extended Phenytoin Sodium capsules nationwide (lot HM03221A) due to failed dissolution specifications, which means the tablets may not dissolve as intended.
Maquet Medical Systems USA is recalling 1,022 Cardiohelp-i blood oxygenation systems due to an insufficient weld on a critical component that may break under manual force.
Percussionaire Corporation recalled 212 Monitron II Waveform Analyzers due to screen freeze issues on visual displays. Affected units were serviced with PAL microprocessor chips and firmware updates.
Encore Medical is recalling DJO EMPOWR Knee Punch Handles due to a manufacturing defect that may cause the handle tip to break during surgery, potentially disrupting the procedure.
AbbVie is recalling 864 cartons of Synthroid (Levothyroxine Sodium) 125mcg tablets due to incorrect barcode labeling. About 1 in 40 blister packs has a barcode showing 200mcg instead of 125mcg, risking dosage confusion.
Encore Medical recalls RSP Humeral Socket Insert implant components due to a packaging error where two different devices were swapped. This could prevent surgeons from having the correct implant available during shoulder surgery.