The FDA has posted 21 enforcement recalls of neurological tray devices since 2025, including 2 Class I (most serious) recalls. Most recent report: Sep 30, 2026.
The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could require medical intervention, such as neu…
The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process.…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab…
Specific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to potential out-of-specification levels of endotoxin of the neurosponges.
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab…
Procedure kits contain MEDICOM Ritmed Neurological Sponges that were recalled due to unexpected variability in endotoxin levels.
Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc.…
The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variab…
Medline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low levels of Bacillus species.
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter c…
Source: U.S. FDA openFDA device enforcement reports, updated continuously. Device type per the FDA's RES classification (“Neurological Tray”). Informational only — verify against the FDA before acting.