The Recall Desk
ModerateFDA (Devices)·Z-0648-2025·Announced 2024-12-11

Medline Recalls Convenience Kits with Recalled SafeAir Smoke Evacuation Pencil

Medline is recalling 1,921 medical convenience kits distributed nationwide that contain SafeAir Smoke Evacuation Pencil components previously recalled by Stryker.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths in the source text. The specific hazard associated with the recalled SafeAir Smoke Evacuation Pencil component is not detailed in the source, making this a precautionary recall of a convenience kit containing a previously recalled component.

Plain-English summary

Medline Industries is recalling 1,921 medical convenience kits that were manufactured using SafeAir Smoke Evacuation Pencil components. The pencil components were previously recalled by Stryker, the manufacturer.

The recalled convenience kits include multiple surgical and ophthalmic products such as eye trays, cataract packs, and ocular packs. These products were distributed nationwide. Affected items can be identified by specific reference numbers and lot codes.

Healthcare facilities and providers with these kits should discontinue use and contact Medline Industries for guidance on replacement or return. For information about the specific defect with the SafeAir Smoke Evacuation Pencil component, see Stryker's original recall notice.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) MINOR EYE TRAY #81, REF DYNJ27466S; 2) EYE PACK, REF DYNJ41207C; 3) CATARACT PACK, REF DYNJ43147G; 4) OSC OCULOPLASTIC PACK, REF DYNJ63329D; 5) OSC OCULOPLASTIC PACK, REF DYNJ63329F; 6) OCULAR PACK, REF DYNJ64138B; 7) OSC BRE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Ophthalmic
Hazard
  • component-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 1) REF DYNJ27466S
  • UDI/DI 10195327350314 (each) 40195327350315 (case)
  • Lot Numbers: 23DBA280
  • 2) REF DYNJ41207C
  • UDI/DI 10195327353063 (each) 40195327353064 (case)
  • Lot Numbers: 23GMD059
  • 23KMH083
  • 3) REF DYNJ43147G
  • UDI/DI 10195327167257 (each) 40195327167258 (case)
  • Lot Numbers: 22FBX412
  • 22FBS940
  • 4) REF DYNJ63329D
  • UDI/DI 10193489958065 (each) 40193489958066 (case)
  • Lot Numbers: 22EBR487
  • 22EBC473
  • 5) REF DYNJ63329F
  • UDI/DI 10195327270414 (each) 40195327270415 (case)
  • Lot Numbers: 23GMC980
  • 23LME454
  • 23IME156

Distribution

Distributed nationwide across the United States.

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