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 recalled 280 units of its Day Surgery General Pack due to humidity control failures that prevent confirmation of adequate sterilization.
Boston Scientific recalls Wallflex FC and Agile Esophageal Stent Systems due to the potential for delivery catheter tip detachment during use. Approximately 145 units are affected worldwide.
American Contract Systems is recalling the Essentia MAJ Laparotomy Std Pack because an equipment failure prevented confirmation of sterilization requirements for this medical convenience kit.
TMJ Solutions Inc is recalling the Stryker TMJ Unilateral Implant because patient-fitted prostheses contained incorrect components. Patients should contact their healthcare provider immediately.
Boston Scientific is recalling Wallflex Esophageal Stent Systems due to potential delivery catheter tip detachment that could affect proper stent deployment during medical procedures.
M&P Delicacies Pirozhki (pies) are recalled due to undeclared wheat and milk in the product. Consumers with allergies to these ingredients should not consume the product.
Niitakaya USA Inc is recalling Miso Katsuo Ninniku pickled garlic because it contains undeclared fish allergen. Consumers with fish allergies should not consume this product.
Boston Scientific recalled 364 esophageal stent systems due to potential delivery catheter tip detachment during placement procedures. No injuries have been reported. Affected patients and providers should contact the manufacturer.
54th St Blackened Sauce is being recalled because soy allergen is present in the product but missing from the label's Contains statement. Consumers with soy allergies should not consume it.
Siemens is recalling ACUSON Juniper ultrasound systems that may perform incorrect unit conversions when configured with non-default settings, potentially producing measurements 10 times smaller than actual values and risking patient misdiagnosis.
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
Boston Scientific is recalling the Agile Esophageal Over-the-Wire Stent System due to potential for delivery catheter tip detachment. Seven affected units distributed worldwide are identified by lot numbers 32889020 and 33178844.
American Contract Systems recalls IR Procedure Pack (Lot 2405102, expiration 05/10/2024) because it cannot confirm sterilization requirements were met. An inoperable chart recorder caused humidity levels to be out-of-specification.
Shiso Katsuo Ninniku pickled garlic products are being recalled due to an undeclared fish allergen. The recall affects 9,482 units distributed across seven states.
Boston Scientific is recalling WallFlex and Agile esophageal stent systems due to potential delivery catheter tip detachment during stent placement procedures.
American Contract Systems recalls the Neuro Vascular ANKV91A medical convenience kit due to inability to confirm sterilization. Affected units were distributed across MO, MN, MA, OH, and NE.
Boston Scientific is recalling Wallflex and Agile Esophageal Stent Systems due to potential for delivery catheter tip detachment. The recall involves 124 units distributed worldwide.
Karl Storz Hopkins Telescope 6 endoscopes are being recalled because the instructions for use contain reprocessing procedures not reviewed or approved by the FDA. Affected units should not be used until corrected instructions are provided.
Roche Diagnostics is recalling Creatine Kinase test reagents that may exhibit abnormal calibrations, producing inaccurate results. Lot 755471 distributed nationwide.
Boston Scientific recalls WallFlex and Agile esophageal stent systems (305 units) due to potential delivery catheter tip detachment. Affected products were distributed worldwide.
Boston Scientific has recalled 308 units of WallFlex and Agile esophageal stent systems due to the potential for delivery catheter tip detachment during stent placement. The affected devices are distributed worldwide.
American Contract Systems is recalling Nasal Sinus Pack units due to manufacturing control failures that prevent confirmation of sterilization. Affected units were distributed to multiple states.
American Contract Systems, Inc. is recalling the Hand Pack AKHD97C medical convenience kit because an inoperable chart recorder caused humidity readings to fall outside specifications, preventing confirmation of sterilization assurance.
Cook Biotech is recalling the Biodesign Fistula Plug implant because devices expire before their labeled expiration dates. Thirty-nine units distributed worldwide are affected.
Karl Storz Hopkins Telescope 6 endoscopes are recalled because their Instructions for Use contain reprocessing procedures that the FDA has not reviewed or approved for safety and efficacy.