The Recall Desk
ModerateFDA (Devices)·Z-0166-2025·Announced 2024-10-30

Medline Medical Procedure Convenience Kits Class II Recall

Medline Industries recalls 22,327 units of medical procedure convenience kits distributed in the US, Canada, and Panama. The FDA Class II recall affects multiple kit variants and is currently ongoing.

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: FDA Class II medical device recall with no reported hospitalizations, injuries, or illnesses cited in the source. The precautionary classification and ongoing status support a Moderate severity level per the rubric.

Plain-English summary

Medline Industries, LP is recalling 22,327 units of medical procedure convenience kits distributed nationwide in the United States and in Canada and Panama. The recall affects over 100 product variants including kits for thoracentesis, chest drainage, dental surgery, cystoscopy, and general surgical applications.

The recall is classified as FDA Class II and is marked as ongoing. The affected kits were identified by specific product reference numbers and lot numbers, with distribution spanning multiple healthcare providers.

Healthcare facilities with affected kits should verify product reference numbers and lot identifiers against the recall details. Facilities should contact Medline Industries for additional information and return instructions regarding the recalled kits.

The recalled product

Product
Medline brand medical procedure convenience kits, labeled as: 1) THORACENTESIS TRAY, REF 00-400616J; 2) HH PACK SONICATION SPEC CONTAI, REF 3706WHST; 3) T&A CDS, REF CDS980427J; 4) EVD CDS, REF CDS984603; 5) CHEST DRAINAGE TRAY, REF CHT745; 6) TRAY FOL TEMP UM 14FR 10ML MF,
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical/Procedure Kits
Hazard
  • product-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 00-400616J
  • UDI/DI 40193489592246 (each)
  • 10193489592245 (case)
  • Lot Numbers: 24ABI725
  • 2) REF 3706WHST
  • UDI/DI 40193489445702 (each)
  • 10193489445701 (case)
  • Lot Numbers: 24ABG100
  • 3) REF CDS980427J
  • UDI/DI 40889942823575 (each)
  • 10889942823574 (case)
  • Lot Numbers: 24DBG751
  • 4) REF CDS984603
  • UDI/DI 40884389853789 (each)
  • 10884389853788 (case)
  • Lot Numbers: 24BBB784
  • 5) REF CHT745
  • UDI/DI 40653160263655 (each)
  • 10653160263654 (case)
  • Lot Numbers: 23LBM800

Distribution

Distributed nationwide across the United States.

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