The Recall Desk
HighFDA (Devices)·Z-0349-2025·Announced 2024-11-20

Surgical hip procedure kit recalled for incomplete product seals

Medline is recalling CARROLLTON HIP FX surgical kits due to incomplete seals on items within the kit. Affected units contain Lot Number 24EBP466 and were distributed in Tennessee.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall involves a surgical medical device with compromised packaging that presents a sterility risk to patients. No illnesses or injuries have been reported, which per the rubric caps the score at High per the rule that theoretical hazards with no reported adverse events do not exceed score 3.

Plain-English summary

Medline Industries, LP is recalling CARROLLTON HIP FX Convenience kits (SKU SYNJ910003A) used for surgical procedures. The recall affects 36 units with Lot Number 24EBP466 distributed in Tennessee.

The issue: Products within the kit may be packaged with incomplete seals, creating gaps in the packaging. Incomplete packaging seals can compromise the sterility of items within the surgical kit, which is critical for their safe use in surgical procedures.

Affected Lot: 24EBP466 (UDI-DI: 10889942848447). This is a Class II recall issued by the FDA.

The recalled product

Product
CARROLLTON HIP FX Convenience kit used for surgical procedures, SKU SYNJ910003A
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical Kit / Orthopedic
Hazard
  • incomplete-seal
  • sterility-risk

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 (2)

  • UDI-DI:10889942848447
  • Lot Number: 24EBP466

Distribution

Distributed nationwide across the United States.

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