Class 2 Device Recall BD MaxGuard/BD MaxPlus

• Date Initiated by Firm: June 16, 2026
• Date Posted: August 13, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2941-2026
• Recall Event ID: 99264
• 510(K)Number: K051499 K083472
• Product Classification: Set, administration, intravascular - Product Code FPA
• Product: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The lntravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.
• Code Information: 60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 Lot Number: 26025260 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 Lot Number: 26035455 9 IN Extension Set w/Max Y REF MPX5300-C UDI-DI code: 10885403237218 Lot Number: 26055528
• FEI Number: 3012798826
• Recalling Firm/ Manufacturer: BD SWITZERLAND SARL; Terre Bonne Park A4; Route De Crassier 17; Eysins Switzerland
• For Additional Information Contact: Adam Daniels; 385-583-9999
• Manufacturer Reason for Recall: Due to mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in products not being sterilized correctly.
• FDA Determined Cause: Process control
• Action: On 06/16/2026, an "URGENT: Medical Device Recall" Letter was emailed to customers informing them that, BD has identified a mechanical issue with internal sterilization equipment resulting in potential underdosing of product during processing, which may have resulted in product not being sterilized correctly. Customer are instructed to: "Immediately discontinue use of the affected lot(s). "Check all inventory locations within your facility and destroy all affected units in accordance with your facility s process. If destruction is not immediately possible at your facility, then product should be quarantined until disposal. "If product is currently in use, replace with non-impacted product as soon as possible. 1. Provide a copy of this notification to any customers and/or facilities you may have distributed devices to. 2. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification. 3. Report any adverse health consequences experienced with the use of this product to BD. Events may also be reported to the FDA's MedWatch Adverse Event Reporting program via: Web: MedWatch website at www.fda.gov/medwatch Phone: 1-800-FDA-1088 (1-800-332-1088) Mail: MedWatch, HF-2, FDA, 5600 Fisher s Lane, Rockville, MD 20852-9787 4. Report any complaints experienced with the use of this product to BD via the North American Regional Complaint Center: Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT Email: productcomplaints@bd.com For: Product Complaints, Technical Questions Phone: 1-844-8BD-LIFE (1-844-823-5433) Say Product Complaints when prompted Mon Fri 8:00am and 5:00pm CT
• Quantity in Commerce: 93,700
• Distribution: U.S.: AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MS, NC, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA O.U.S.: Canada
• 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 = FPA; 510(K)s with Product Code = FPA