Medline Industries, LP: 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.

Recall number

Z-0516-2026

Recalling firm

Medline Industries, LP

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.

Status

Open, Classified

Initiated

2025-09-30

Posted

2025-11-14

Terminated

not on file

Reason

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.

Root 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

3078 kits

Distribution

US Nationwide distribution.

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OGR

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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