State
72,919 recalls have nationwide distribution and so reach Maine. 3,894 additional recalls listed Maine specifically in their distribution scope.
Of the 3,894 recalls naming Maine we have scored against our rubric, 468 (12%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 791 (20%) are Severe.
Which agencies issued them
These figures cover only the 3,894 recalls whose distribution notice names Maine specifically. The 72,919 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
The FDA has rescinded the 510(k) regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing components in Medline's General Laparoscopy Kit (Model CDS930027Y). Affected units should not be used.
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kits because the 510(k) clearances for certain control syringes, guidewires and high-pressure tubing were rescinded.
Arrow International is recalling the Arrowgard Blue MAC Two-Lumen Central Venous Access Kit due to incorrect manufacturing of the liquid adhesive by a supplier. The recall affects 95 units distributed in nine U.S. states.
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nationwide because regulatory clearances for certain Control Syringes, Guidewires, and High-Pressure Tubing have been rescinded.
SurgiSmoke Solutions is recalling certain lots of the Flamingo Funnel Large (Model SQ20012-03) surgical device due to a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape.
Medline Industries has recalled multiple control syringes, guidewires, and high-pressure tubing models because their FDA 510(k) regulatory clearances have been rescinded. The recall affects 38,230 units distributed nationwide.
Hetero Labs Limited is recalling Pantoprazole Sodium 40 mg delayed-release tablets due to discoloration—some tablets are darker than normal with lighter-colored spots. The firm received five complaints about the affected tablets.
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.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2110) because the Version 2 reprocessor connecting tube lock levers may fail prematurely. The tubes are used to reprocess endoscopes.
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.
Leading Pharma, LLC is recalling Furosemide 80 mg tablets due to the presence of N-nitroso-Furosemide (NNF) above the recommended intake limit, caused by manufacturing deviations.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA 510(k) clearance.
Medline Industries is recalling select Convenience Kits containing 10mL polycarbonate colored syringes due to unapproved design changes made outside of FDA 510(k) clearance.
FDA has rescinded the 510(k) clearances for certain Medline medical device kits including control syringes, guidewires, and high-pressure tubing. Medline is recalling approximately 58,836 units distributed nationwide.
Olympus is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2111) because the Version 2 reprocessor connecting tube lock levers may fail prematurely.
Medline Industries is recalling certain surgical and medical kits because their 510(k) regulatory clearances for Control Syringes, Guidewires, and/or High-Pressure Tubing have been rescinded. About 2,609 units were 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.
Medline Industries has had its 510(k) regulatory clearances rescinded for certain Control Syringes, Guidewires, and High-Pressure Tubing used in a large number of catheterization and angiography kits. The kits are distributed nationwide.
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.
Medline Industries is recalling three ENT and vascular kits (513 units nationwide) because their regulatory clearances for certain components—Control Syringes, Guidewires, and/or High-Pressure Tubing—have been rescinded.
Medline Industries has recalled the GYN Laparoscopy Pack (Model DYNJ41257F, Lot 25GBL423) because its regulatory clearances for certain components—including Control Syringes, Guidewires, and High-Pressure Tubing—have been rescinded.
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.
Medline Industries has issued a recall of Medline Namic Guidewires because their FDA 510(k) regulatory clearances have been rescinded. The affected units were distributed nationwide.
Medline Industries is recalling Convenience Kits containing 10mL Polycarbonate Colored Syringes due to unapproved design changes made outside of FDA clearance. The recall affects 270,311 units distributed nationwide and internationally.
Medline Industries is recalling certain convenience kits containing 10mL polycarbonate colored syringes because of unapproved design changes made outside of FDA 510(k) clearance. The affected kits were distributed nationwide and to Canada, Panama, and Barbados.