Severity 2 of 5
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.
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.
SurgiSmoke Solutions is recalling certain lots of Flamingo Funnel Medium (Model SQ20012-02) because a non-gamma sterilization compatible drape was used during manufacturing, which could affect device safety.
Magellan Diagnostics is recalling the LeadCare Ultra Blood Lead Test Kit (Catalog Number 70-8098) because use with certain third-party micro-collection devices may produce unexpectedly elevated and false positive results, potentially causing delayed diagnosis and unnecessary additional testing.
Arrow International is recalling 395 pressure injectable central venous catheters across nine U.S. states due to incorrect manufacturing of the liquid adhesive by a supplier.
Foundation Medicine is recalling Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx due to potential spontaneous closures of Hamilton HxRunControl software during protocol execution.
Medline Industries is recalling D and C Pack kits (Model DYNJ41254B) nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed nationwide and internationally.
Arrow International is recalling Arrow Radial Artery Catheterization Kits due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 675 units distributed nationwide.
Olympus Corporation recalls OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2115) due to a defect. The recall affects approximately 2,089 units distributed nationwide and internationally.
Magellan Diagnostics is recalling LeadCare II Blood Lead Test Kits because certain third-party micro-collection devices may produce falsely elevated lead results, potentially causing unnecessary testing and delayed results.
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2112) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Micro-X Ltd. is recalling certain Rover Mobile X-ray Systems (models MXU-RV35 and MXU-RV71) because the X-ray generator may malfunction, rendering the device inoperable.
Medline Industries is recalling Medline Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA clearance.
Medline is recalling a range of custom left heart and catheterization kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Small (Model SQ20012-01) due to a manufacturing issue involving use of a non-gamma sterilization compatible drape.
Olympus Corporation is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2330) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Arrow International is recalling 85 units of the Arrow Echogenic Introducer Needle due to incorrect manufacturing of the liquid adhesive used in the device.
FDA has rescinded 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in two Medline medical device kits distributed nationwide.
XTANT Medical Holdings is recalling nanOss 3D Advanced Bone Graft Substitute products due to incorrect labeling showing a 5-year shelf life when the approved shelf life is four years.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2114) because the Version 2 reprocessor connecting tube lock levers may fail prematurely, potentially affecting equipment operation and patient safety during endoscope reprocessing.
B. Braun is correcting gravity and pump administration sets used with specific infusion pumps due to risk of medication backflow from secondary containers into primary containers and occlusion during priming.
B. Braun Medical Inc. is recalling Lactated Ringers Irrigation 3000 mL bags due to lack of assurance of sterility and potential leakage from the diaphragm port after foil removal.
The Harvard Drug Group LLC is recalling Omega-3-Acid Ethyl Esters capsules (1 gram, 50-count cartons) due to failed capsule specifications discovered during routine stability testing.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects approximately 270,311 units distributed in the US and internationally.
The FDA has rescinded regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing included in Medline's Arthroscopy Pack (Model DYNJ82440). Affected units should not be used.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance. The recall affects syringes distributed worldwide, including the US, Canada, Panama, and Barbados.