The FDA has classified a Class II recall for Boston Scientific's EndoVive Safety PEG Kit, identified by recall number Z-1551-2026, with an ongoing status as of March 18, 2026. The recall is due to issues with the outer box material number M00509001 and inner box material number M00509000, specifically concerning the ChloraPrep Triple Swabsticks from BD. The seals on the sterile swabstick packaging were found to be open or compromised, which could lead to a loss of sterility or drying of the antiseptic solution, impacting the integrity of the product. The affected product was distributed nationwide in the US.

Healthcare providers and medical device makers should be aware of this recall and review their inventory of the affected EndoVive Safety PEG Kits. While the document does not specify a compliance deadline for action, entities in possession of these kits should follow Boston Scientific's specific recall instructions and quarantine or return affected products to prevent potential patient harm due to compromised sterility. The FDA classifies this as a Class II recall, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.