Class 2 Device Recall MEDLINE

• Date Initiated by Firm: September 30, 2025
• Date Posted: November 14, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0516-2026
• Recall Event ID: 97846
• Product Classification: Ear, nose, and throat surgical tray - Product Code OGR
• Product: MEDLINE convenience kits labeled as: 1) HEAD AND NECK, REF CDS984259O; 2) HEAD AND NECK, REF CDS984259P; 3) MINOR ENT HARPER PACK-LF, REF DYNJ0160700F; 4) MAJOR ENT HARPER PACK-LF, REF DYNJ0161710I; 5) THORACOTOMY HARPER PACK-LF, REF DYNJ0161795F; 6) MAJOR ENT MZ PACK-LF, REF DYNJ0429404O; 7) MAJOR ENT MB PACK-LF, REF DYNJ0429404P; 8) THYROID MOFF PACK-LF, REF DYNJ0429430S; 9) NASALPLASTY #61-RF, REF DYNJ27320V; 10) MIDDLE EAR PACK, REF DYNJ55235C; 11) HEAD AND NECK, REF DYNJ64235B; 12) NECK PACK SRM-LF, REF DYNJ65020C; 13) ACH HEAD & NECK PACK-LF, REF DYNJ67754B; 14) ENT HEAD NECK PACK, REF DYNJ68211B; 15) OSC ENT HEAD PACK, REF DYNJ68957B; 16) EAR UM-LF, REF DYNJ902331D; 17) HEAD&NECK, REF DYNJ906655G; 18) ENT-LF, REF DYNJ907577; 19) MAJOR HEAD AND NECK PPS, REF DYNJ9425991Q; 20) MINOR ENT # 56653-LF, REF DYNJVB91072A.
• Code Information: 1) REF CDS984259O: UDI/DI 10195327297817 (each), 40195327297818 (case), Lot Numbers: 23FBR754, 23GBH766, 24ABP608, 24BBN514; 2) REF CDS984259P: UDI/DI 10195327647827 (each), 40195327647828 (case), Lot Numbers: 24DBQ755; 3) REF DYNJ0160700F: UDI/DI 10195327304294 (each), 40195327304295 (case), Lot Numbers: 23FDA156, 23GDA649; 4) REF DYNJ0161710I: UDI/DI 10195327375003 (each), 40195327375004 (case), Lot Numbers: 23EDB639, 23FDA196, 23GDA674; 5) REF DYNJ0161795F: UDI/DI 10195327375010 (each), 40195327375011 (case), Lot Numbers: 23FDA246, 23HDA365; 6) REF DYNJ0429404O: UDI/DI 10195327050092 (each), 40195327050093 (case), Lot Numbers: 23GMI073, 23JMC414, 23LMA073; 7) REF DYNJ0429404P: UDI/DI 10195327587581 (each), 40195327587582 (case), Lot Numbers: 23LMH745, 24BME178, 24DMF230; 8) REF DYNJ0429430S: UDI/DI 10195327689841 (each), 40195327689842 (case), Lot Numbers: 24LME516; 9) REF DYNJ27320V: UDI/DI 10195327104719 (each), 40195327104710 (case), Lot Numbers: 23GBT502, 24ABD023, 24ABX584, 24DBA020, 24DBU467, 24FBD739; 10) REF DYNJ55235C: UDI/DI 10195327412081 (each), 40195327412082 (case), Lot Numbers: 23GBN444, 23IBU467; 11) REF DYNJ64235B: UDI/DI 10193489382662 (each), 40193489382663 (case), Lot Numbers: 23FMB928; 12) REF DYNJ65020C: UDI/DI 10195327528218 (each), 40195327528219 (case), Lot Numbers: 23JMD840, 23LME135, 24FMH184; 13) REF DYNJ67754B: UDI/DI 10195327227982 (each), 40195327227983 (case), Lot Numbers: 23EBK256, 23HBM886, 23IBP461, 23JBR528; 14) REF DYNJ68211B: UDI/DI 10195327352493 (each), 40195327352494 (case), Lot Numbers: 23HMC691; 15) REF DYNJ68957B: UDI/DI 10195327512033 (each), 40195327512034 (case), Lot Numbers: 23JMD230, 24AMB618; 16) REF DYNJ902331D: UDI/DI 10195327698089 (each), 40195327698080 (case), Lot Numbers: 24EBC946, 24EBV522; 17) REF DYNJ906655G: UDI/DI 10195327301835 (each), 40195327301836 (case), Lot Numbers: 24ADB523; 18) REF DYNJ907577: UDI/DI 10193489437713 (each), 40193489437714 (case), Lot Numbers: 23GBB195, 23GBN735; 19) REF DYNJ9425991Q: UDI/DI 10195327587604 (each), 40195327587605 (case), Lot Numbers: 24ALB133; 20) REF DYNJVB91072A: UDI/DI 10195327466428 (each), 40195327466429 (case), Lot Numbers: 23HLB079, 23ILA192, 24ALA650.
• Recalling Firm/ Manufacturer: Medline Industries, LP; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Haley Barclay; 800-369-1704
• Manufacturer Reason for Recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.
• FDA Determined Cause: Under Investigation by firm
• Action: Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions: 1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form. 3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 4. For distributors or those who 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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
• Quantity in Commerce: 3078 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.