Class 1 Device Recall Medline Convenience Kits

• Date Initiated by Firm: August 11, 2026
• Date Posted: September 14, 2026
• Recall Status: Open, Classified
• Recall Number: Z-3126-2026
• Recall Event ID: 99669
• Product Classification: Wound dressing kit - Product Code MCY
• Product: Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
• Code Information: 1) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBF076; 2) DYNDH1193, UDI-DI: 10889942499953(each), 40889942499954(case), Lot Number: 24HBU638; 3) DYNDH1487A, UDI-DI: 10193489484311(each), 40193489484312(case), Lot Number: 24FMH485
• FEI Number: 1417592
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 866-359-1704
• Manufacturer Reason for Recall: The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillus penicillioides. Contamination of skin preparation products with Aspergillus penicillioides may lead to serious adverse health consequences, including systemic infection, sepsis, illness, and death.
• FDA Determined Cause: Nonconforming Material/Component
• Action: An URGENT MEDICAL DEVICE RECALL notification letter dated 8/11/26 was sent to customers. This communication serves as an update to the Medline notification sent on June 12, 2026. Please be advised that the actions required for certain item(s) and lot(s) identified in the original notification have changed based on additional recall details received from BD (Becton, Dickinson and Company). REQUIRED ACTION: 1.Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-097-FGX3 Recall Code: 3.Your account will receive credit once the response form is submitted. 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 1100 kits
• 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.