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.
Abbott Laboratories is recalling Similac Stage 1 infant formula due to compromised seal integrity on 14,588,544 bottles. The defect could allow product spoilage.
ICU Medical is recalling 137,120 bags of 0.9% Sodium Chloride Injection because bags may leak and potentially compromise sterility. The affected lot (5829936) was distributed nationwide.
Adam's Polishes hand sanitizer with 75% isopropyl alcohol is being recalled due to methanol contamination found in certain lots manufactured under non-compliant conditions. The product was distributed nationwide.
CareFusion GENESIS sterilization containers did not consistently meet aerosol challenge testing requirements. These containers are used in healthcare facilities to sterilize surgical instruments.
ImprimisRx is recalling 960 bottles of compounded Timolol-Latanoprost ophthalmic drops nationwide. Affected batches contain less than 90% of the labeled latanoprost amount.
CareFusion Genesis reusable sterilization containers are recalled after failing aerosol challenge testing requirements. No illnesses or injuries have been reported.
CareFusion GENESIS sterilization containers have not consistently met aerosol challenge testing requirements. Approximately 1,132 units distributed to healthcare facilities in the U.S. and internationally are affected.
Abbott Laboratories is recalling Similac Total Comfort 2 fl oz bottles due to compromised seal integrity that could allow spoilage. Approximately 14.5 million bottles are affected across the US and international markets.
Howmedica distributed bone cement under incorrect part number 6193-1-010 instead of ordered 6195-1-010. The distribution error affected 90 units shipped nationwide.
LeMaitre Vascular recalled three lots of TufTex Embolectomy Catheters with inadequate ligature ties. The defect risks the catheter tip breaking off and becoming lodged in a blood vessel.
The back rest of Getinge operating table extension tabletops may drop unexpectedly, posing a fall hazard to patients. No injuries have been reported.
Reusable sterilization containers manufactured by Carefusion have not consistently met aerosol challenge testing requirements. 483 units distributed in the US and internationally are being recalled.
Abbott Laboratories is recalling Similac Special Care 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Affected bottles have batch number 41861N200 with a best-by date of 06/01/23.
The Bentex Group is recalling about 87,000 children's clothing sets because the textile ink contains lead levels that violate federal regulations. Lead is toxic if ingested and can cause health problems in young children.
CareFusion Genesis sterilization containers have failed to consistently meet aerosol challenge testing, potentially leaving surgical instruments inadequately sterilized. 318 units distributed in the US and internationally.
Covidien recalls Endo Stitch V-Loc 180 automated suturing devices due to 210 reports of needles breaking during endoscopic surgery. Broken needle fragments may remain in patients, potentially causing tissue injury and requiring additional imaging.
Nash Family Creamery Ranch Cheese Curd 8oz bags are recalled due to undeclared soy allergen. The product was distributed to Tennessee and Kentucky.
Indigo Books & Music is recalling Papa Bear and Mama Bear ceramic mugs that can crack or break when filled with hot liquid, posing burn and laceration hazards. About 270 units were sold in the U.S.
CareFusion Genesis reusable sterilization containers have not consistently passed aerosol challenge testing, which verifies their ability to properly sterilize medical instruments. Approximately 537 units were distributed internationally.
Navistar is recalling 196 model-year 2023 IC BUS CESB buses due to defective fuel vapor lines. Without proper heat shielding, the lines may leak when exposed to exhaust heat, posing a fire risk.
Novapproach Spine is recalling OneLIF Torque Limiting Adapter components used in spinal surgery instruments because the adapter may not remain locked in the ratcheting handle once fully engaged. This could compromise surgical instrument function during use.
CareFusion Genesis Mini Containers used for surgical instrument sterilization have not consistently met aerosol challenge testing requirements, which may affect their ability to protect instruments during sterilization.
Abbott Laboratories recalls Pedialyte Unflavored 2 fl oz bottles for compromised seal integrity that could allow spoilage. Affected bottles were distributed across the United States and multiple countries.
Abbott Laboratories is recalling Similac 360 Total Care Sensitive infant formula in 2 fl oz bottles due to compromised seal integrity that could lead to spoilage. Approximately 15.9 million bottles are affected across the United States and international locations.
Teleflex Medical recalled approximately 7,200 RUSCH Pocket Pac i.c. urinary catheter kits due to potential sterility issues. Patients should contact their healthcare provider and discontinue use.