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.
Boston Scientific is recalling 38 units of Extractor Pro XL Retrieval Balloon Catheters due to potential defects in skive hole location or balloon size.
King Systems Corp. is recalling King LTSD Kit Size 4 supraglottic airway devices because some packages contained KLTD214 airways that lack a required gastric suction tube lumen.
Lupin Pharmaceuticals is recalling Quinapril 10 mg tablets because stability testing revealed an unknown impurity above specification limits.
Boston Scientific is recalling 3,300 TWISTER PLUS 26mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Atrium Medical Corporation is recalling 624 units of Ocean Water Seal Chest Drain ATS Blood Recovery Systems because the tubing may leak or disconnect.
Jensen's Old Fashioned Smokehouse is recalling hot smoked salmon because inconsistent 'KEEP FROZEN' labeling creates a potential risk of Clostridium botulinum contamination.
The Anspach Effort, Inc. is recalling 183 Anspach MIA 16 attachments because they did not reach the expected sterility assurance level.
Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
Midwest-CBK is recalling about 1,900 baby rattles because the head can detach, posing a choking hazard to young children.
Aidapak Services is recalling lamoTRIgine tablets that may be mislabeled as oxybutynin chloride or fexofenadine HCL. The error could lead to patients taking the wrong medication.
Aidapak Services is recalling 700-tablet bottles of 20 mg Famotidine tablets because they may be mislabeled as other medications.
Boston Scientific is recalling TWISTER PLUS 22mm Rotatable Retrieval Devices because the pouch seal integrity may be compromised, potentially affecting sterility.
The Anspach Effort, Inc. is recalling carbide cutting burrs and drums because some fractured during use. The products are used for cutting and shaping bone.
Teleflex Medical is recalling 17,450 electrosurgical coagulation suction tubes because sterility cannot be guaranteed. The devices were distributed nationwide.
The Anspach Effort, Inc. is recalling specific carbide cutting burrs because some fractured during use. The devices are intended for cutting and shaping bone.
The Anspach Effort, Inc. is recalling single-use sterile bone cutting burs and irrigation clips due to observed layer separation that may compromise the sterile barrier.
Mariposa Labs is recalling NorthStar Arthritis Relief Cream because the product failed microbiological specifications.
Atrium Medical Corporation is recalling 361 units of the Ocean Water Seal Chest Drain ATS Blood Recovery System because the tubing may leak or disconnect.
Aidapak Services, LLC is recalling guaiFENesin ER tablets because they may be mislabeled as fenofibrate or glyburide. The error poses a risk of patients taking the wrong medication.
Whole Foods Market is recalling Artichoke Wheatberry Salad in Northern California because ingredients are under recall for potential E. coli O157:H7.
Aidapak Services, LLC is recalling Isosorbide Mononitrate ER tablets because they may be mislabeled as other prescription drugs.
Aidapak Services is recalling methylprednisolone tablets that may be mislabeled as levothyroxine sodium due to a labeling mixup.
GE Healthcare is recalling 28 units of Merge Mammo software version 8.0.2 because images may display out of sync with the navigator, potentially leading to misdiagnosis.
Aidapak Services is recalling 1,582 Nicotine Polacrilex Lozenges because they may be mislabeled as other prescription drugs.
Nationwide Industries is recalling Trident Pool Gate Latches because the magnet can come loose, preventing the gate from securing. No injuries were reported.