Class II U.S. Food and Drug Administration

Medline convenience kits labeled as: 1) Head AND Neck, REF CDS984259O recall: Medline Industries, LP is issuing a recall for specific item(s) and lot(s)

Recall published 11 months ago

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.

The hazard

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.

Recall details

Recall number
Z-0516-2026
Published
November 26, 2025
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Medline Industries, LP
Product type
Medical devices
Units affected
3078 kits
Distribution
Nationwide
Made in
United States
Lot / code info
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.

Products covered by this recall

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.

What this device recall means for you

Most device recalls are corrections rather than removals: the product stays in use and the manufacturer issues updated instructions, a software patch or a replacement part. Check which applies before you change anything.

  1. Match the model, catalogue and lot numbers above against the label on your device or its packaging.
  2. If the device is implanted or you depend on it daily, do not remove, disable or stop using it before speaking to your clinician. The notice above explains the specific failure mode they need to know about.
  3. If you are a clinician or facility, quarantine affected stock, check whether the manufacturer has issued a field correction, and work through your usual recall log.
  4. Home users should contact the supplier who provided the device — a hospital, DME company or online retailer — as they hold the serial-number records needed to action the recall.
  5. Problems with a device can be reported to the FDA through MedWatch, which feeds the same enforcement database this page is built from.

Replacements, repairs and reimbursement

Device remedies are handled through the supply chain, so the route depends on who sold you the unit.

  • Contact the distributor or clinic named on your paperwork and quote the recall number shown on this page. They will tell you whether the remedy is a repair, a replacement or an instruction update.
  • Consumer-purchased devices such as monitors and test kits are normally replaced free of charge by the manufacturer, who pays return shipping.
  • If the device was billed to insurance or Medicare, the replacement is usually billed the same way; you should not be charged a second deductible for a recall.
  • Keep every piece of correspondence. If a recalled device caused harm, that paper trail is what a claim will rest on.

Company contact: Medline Industries, LP — 3 Lakes Dr, Northfield, IL, 60093-2753

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

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