Class 2 Device Recall Vesco Q 40mm Screw Cap Feed Set

• Date Initiated by Firm: October 08, 2026
• Date Posted: November 06, 2026
• Recall Status: Open, Classified
• Recall Number: Z-0376-2027
• Recall Event ID: 100054
• 510(K)Number: K232205
• Product Classification: Pump, infusion, enteral - Product Code LZH
• Product: Vesco Q 40mm Screw Cap Feed Set, Model Number VED-052
• Code Information: UDI-DI 00850002550474; Lot Numbers: all lots manufactured through 12/20/2204
• FEI Number: 3012169247
• Recalling Firm/ Manufacturer: Vesco Medical Llc; 60 Collegeview Rd Space 144; Westerville OH 43081-1429
• For Additional Information Contact: Pump Recall Hotline; 833-377-8399
• Manufacturer Reason for Recall: The feeding pump may deliver enteral fluids outside its labeled accuracy specification of +/-5%. This inaccuracy can result in over-delivery or under-delivery of enteral fluids relative to the prescribed dose, if proper controls are not in place. Over- or under-delivery of enteral nutrition through the pump and associated feed sets could cause temporary or medically reversible adverse health consequences, with a remote probability of serious adverse health consequences.
• FDA Determined Cause: Under Investigation by firm
• Action: An URGENT: MEDICAL DEVICE RECALL notification letter dated 10/8/26 was sent to customers. What You Should Do " Immediately identify all Vesco Medical Q" Enteral Feeding Pumps (REF: VED-701). " If you have distributed any affected product to a consignee, forward this notification to them immediately. For patients using this device at home, ensure that the patient or their caregiver has received both this notice and the supplemental instructions provided below. " For patients sensitive to feed rate, including but not limited to, vulnerable populations such as pediatric subpopulations, patients receiving insulin dosed to their prescribed feeding rate, patients with metabolic disorders requiring continuous carbohydrate delivery, fluid-restricted patients, patients being fed jejunally, and any patient for whom the prescribing physician determines that precise delivery rate is clinically necessary, stop using the Q Pump and seek an alternate pump from your supplier. " For patients not sensitive to feed rate, follow the supplemental instructions provided to continue using the Q Pump. " Report any adverse events or quality problems experienced with this device to Vesco Medical at (833) 377-8399 or info@vescomedical.com and to FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088.patients being fed jejunally, and any patient for whom the prescribing physician determines that precise delivery rate is clinically necessary, stop using the Q Pump and seek an alternate pump from your supplier. " For patients not sensitive to feed rate, follow the supplemental instructions provided to continue using the Q Pump. " Report any adverse events or quality problems experienced with this device to Vesco Medical at (833) 377-8399 or info@vescomedical.com and to FDA MedWatch at www.fda.gov/medwatch or 1-800-FDA-1088. Supplemental Instructions for Mitigating Risk For patients who are not sensitive to feed rate, continued use may be appropriate if the treating physician determines that pre
• Quantity in Commerce: 2,880 units
• Distribution: US Nationwide distribution.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LZH