The Recall Desk
ModerateFDA (Devices)·Z-0634-2025·Announced 2024-12-11

Medline Convenience Kits Recalled Due to Defective Smoke Evacuation Component

Medline is recalling 14,388 surgical convenience kits nationwide manufactured with certain lots of SafeAir Smoke Evacuation Pencils previously recalled by Stryker. Affected kits should not be used.

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 a Class II medical device recall for surgical kits manufactured with component lots previously recalled by the component supplier. No specific hazards, illnesses, or injuries are reported in the recall notice. This is a precautionary recall of a supply chain component.

Plain-English summary

Medline Industries is recalling 14,388 surgical convenience kits that were manufactured using certain lots of SafeAir Smoke Evacuation Pencils. The pencil component was previously recalled by Stryker, the component manufacturer. The recall affects 27 different Medline kit product configurations distributed nationwide in the United States.

The affected kits are used in surgical and operating room settings. Specific lot numbers and UDI codes for each affected kit configuration are available from the FDA recall notice. The source notice does not specify the particular hazard or reason for the underlying component recall by Stryker, nor are any reported illnesses or injuries disclosed.

Healthcare facilities and surgical centers that have received these kits should immediately stop using products containing the recalled lot numbers. Contact Medline Industries for instructions on returning the recalled kits or obtaining replacement products.

The recalled product

Product
MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, RE
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kits
Hazard
  • recalled-component

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 DYNJ0619907I
  • UDI/DI 10195327239480 (each) 40195327239481 (case)
  • Lot Numbers: 22IMG033
  • 2) REF DYNJ0619907K
  • UDI/DI 10195327295905 (each) 40195327295906 (case)
  • Lot Numbers: 22LME111
  • 3) REF DYNJ0619907L
  • UDI/DI 10195327333119 (each) 40195327333110 (case)
  • Lot Numbers: 23JBH171
  • 23HBV761
  • 23FMI052
  • 4) REF DYNJ06966M
  • UDI/DI 10195327349059 (each) 40195327349050 (case)
  • Lot Numbers: 23EBR799
  • 23IBI141
  • 23KBC445
  • 23LBJ670
  • 5) REF DYNJ0867331G
  • UDI/DI 10195327118433 (each) 40195327118434 (case)
  • Lot Numbers: 22EDA376

Distribution

Distributed nationwide across the United States.

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