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.
Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.
Moximed is recalling 115 MISHA Knee System Implants in multiple US states due to a supplier component defect that may cause the implant to fracture, potentially leading to pain, swelling, and stiffness.
Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (bottles).
Medline Industries recalls specific lots of surgical patties and strips in MAJOR NEURO PACK-LF Convenience kits due to higher-than-expected endotoxin levels detected in raw materials, which may have resulted in out-of-specification finished products.
Medline brand surgical procedure convenience kits in specific lots contain higher-than-expected endotoxin levels in surgical patties and strips. The contamination was found in raw materials used to produce sterile components.
Medline Industries is recalling FESS-MB PACK-LF Convenience kits containing surgical patties and strips due to higher-than-expected endotoxin levels in raw materials, resulting in out-of-specification finished products.
3M is recalling Clarity Precision Grip Attachments due to a design defect that may prevent proper fitting with digital treatment plans. The recall affects 171 orders distributed in the US, Canada, Australia, and New Zealand.
Medline Industries is recalling 21,440 units of the ST IUD Removal Hook due to weak seals that may compromise sterility. The defect is undetectable to users and could increase infection risk.
BD FACSLyric flow cytometers are recalled for power supply failures that may prevent the device from powering on, risking specimen loss and potential respiratory effects from fume inhalation.
Medline surgical patties and strips used in certain procedure convenience kits were found to contain higher-than-expected endotoxin levels that may exceed safety specifications. The affected kits were distributed nationwide and in Canada.
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules due to N-nitroso-duloxetine impurity above recommended limits. The affected product was distributed nationwide in 1,815 bottles with two specific lot numbers and expiration dates.
Encore Medical recalls EMPOWR 3D Knee Tibial Insert packages that may contain the wrong size implant (5R 16MM with 3R 14MM and vice versa), potentially delaying surgery. The recall affects 33 units nationwide.
Siemens is recalling epoc NXS Host blood analysis systems due to a software malfunction that can assign incorrect patient names to test results, potentially leading to misdiagnosis and mistreatment if not verified by the user.
Siemens epoc NXS blood analysis system has a software defect that can incorrectly assign patient names to blood test results, potentially causing misdiagnosis or mistreatment.
Amerisource Health Services is recalling certain lots of Duloxetine Delayed-Release Capsules due to N-nitroso impurity levels exceeding recommended limits. Consumers with the medication should contact their healthcare provider.
Medline Industries is recalling SEPTOPLASTY PACK convenience kits nationwide due to higher-than-expected endotoxin levels in surgical patties and strips. The contamination may pose infection risks during surgical procedures.
Glenmark Pharmaceuticals is recalling Chlorpromazine Hydrochloride tablets due to manufacturing deviations that resulted in an impurity exceeding FDA limits. The affected lot (17230133, expiring 12/31/2024) was distributed nationwide.
SeaSpine Orthopedics is recalling 92 Daytona Small Stature CoCr Locking Caps due to manufacturing defects that prevent proper component mating. The devices were distributed in seven U.S. states.
Siemens is recalling two lots of Magnesium Flex reagent cartridges due to potential falsely low magnesium measurements. The intermittent error may not be detected by standard quality control procedures.
Noah Medical's Galaxy System bronchoscope has defective power supply semiconductors that may fail during procedures, potentially causing pneumothorax or lung tissue injury when the scope is manually removed.
BD is recalling FACSLyric flow cytometer power supplies that may fail to power on or stay on, creating risks of fume inhalation and requiring patients to return for repeat biospecimen collection procedures.
SEASPINE Orthopedics is recalling 191 Daytona Small Stature Ti Locking Caps due to manufacturing defects that prevent proper component mating.
Abbott Vascular is recalling the 20/30 Priority Pack Accessory Kit w/Copilot inflation device used in cardiovascular procedures because it may leak at connection points, potentially causing air embolism.
Medline has recalled Sterile Magill Forceps (Item No. 66790) due to weak seals that may compromise sterility. The defect affects approximately 21,440 units distributed nationwide.
Siemens epoc NXS Host blood analysis systems are recalled due to a software malfunction that can assign incorrect patient names to blood tests, potentially leading to misdiagnosis or mistreatment.