The Recall Desk
HighFDA (Devices)·Z-0760-2025·Announced 2025-01-01

RUMMELL Medline Medical Device Weak Seals Sterility Risk Recall

Medline RUMMELL units may have weak seals that could compromise sterility and increase infection risk. Approximately 21,440 units distributed nationwide are affected.

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: FDA Class II medical device with theoretical risk of contamination and infection from compromised sterility. No reported illnesses or injuries documented. The potential for infection from a sterility breach in a medical device constitutes a high-risk situation.

Plain-English summary

Medline Industries is recalling RUMMELL sterile medical devices (Item No. ST006ST, Lot 2023111490) due to weak seals that may breach sterility. Weak seals may not be detectable by users, increasing the risk of contamination and infection.

The recall affects approximately 21,440 units distributed nationwide. Affected products are identified by UDI 10653160251224 (each) and 00653160251227 (case).

Consumers who have received or are using affected RUMMELL devices should contact Medline Industries or consult their healthcare provider regarding their specific product lot. Healthcare facilities should verify their inventory against the provided lot information and quarantine affected units.

The recalled product

Product
RUMMELL, Medline Item No. ST006ST
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Surgical / Sterile Device
Hazard
  • sterility-breach
  • contamination
  • infection

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: 10653160251224 (ea) 00653160251227 (case)
  • Lot 2023111490

Distribution

Distributed nationwide across the United States.

Related recalls

Same category