State
72,913 recalls have nationwide distribution and so reach Guam. 385 additional recalls listed Guam specifically in their distribution scope.
Of the 385 recalls naming Guam we have scored against our rubric, 14 (4%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 37 (10%) are Severe.
Which agencies issued them
These figures cover only the 385 recalls whose distribution notice names Guam specifically. The 72,913 nationwide recalls listed below reach every state, so counting them here would make every state page show the same numbers.
LSL Healthcare is recalling its Wound Closure Tray (Model 7554) distributed nationwide to Maryland, Illinois, and Minnesota because the kits contained non-sterile Webcol Large Alcohol Prep Pads.
Angiodynamics, Inc. recalls Soft-Vu Angiographic Catheter, Cobra (1), Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Angiodynamics is recalling Soft-Vu Angiographic Catheter Kumpe units due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Soft-Vu Pigtail Angiographic Catheters are being recalled because a manufacturing defect may prevent an appropriately sized guidewire from passing through the catheter hub.
LSL Healthcare's Central Line Dressing Kit (Model 2717H) is being recalled because it contains Webcol Large Alcohol Prep Pads that were found to be non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Magellan Diagnostics is recalling LeadCare Plus Blood Lead Test Kits (Catalog Number 82-0004) because they may produce falsely elevated lead results when used with certain third-party micro-collection devices, potentially causing delayed testing and unnecessary follow-up 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 270,311 units distributed nationwide and internationally.
Windstone Medical Packaging is recalling Custom Convenience Kits Pre Op Kit units due to potential backflow of medication between IV containers and risk of priming failure in gravity and pump administration sets.
Angiodynamics is recalling Soft-Vu Angiographic Catheter (Pigtail, Non-Braided) due to a manufacturing defect that may prevent a guidewire from passing through the catheter hub's inner diameter.
Angiodynamics is recalling Soft-Vu Angiographic Catheters (Omni Flush, Non-Braided) due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Kumpe, Non-Braided devices due to a manufacturing defect that may prevent guidewires from passing through the catheter hub.
Angiodynamics is recalling Soft-Vu Angiographic Catheter, Headhunter (1), Non-Braided devices because a manufacturing defect may prevent guidewires from passing through the catheter hub.
The MAC Two-Lumen Central Venous Access Kit is being recalled after a supplier notified the firm that the liquid adhesive used in the device was incorrectly manufactured.
LSL Healthcare is recalling its Foley Urine Collection Kit (Model 1555) because it contains Webcol Large Alcohol Prep Pads that are non-sterile. The kits were distributed nationwide in Maryland, Illinois, and Minnesota.
Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC Kits are being recalled after a supplier notified the firm that the liquid adhesive was incorrectly manufactured.
Foundation Medicine is recalling Sequencing Agent SEQ0067, a component of the FoundationOne CDx test, due to a possible increase in phasing that could result in false-positive BARD1 splice site indel artifact variants.
Olympus Corporation of the Americas is recalling OER-ELITE Endoscope Reprocessor Connecting Tubes (Model MAJ-2119) due to potential premature failure of the Version 2 reprocessor connecting tube lock levers.
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.
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.
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.
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 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.
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.
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.
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.