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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 21,440
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.
Part of a larger recall action
This product is one of 7 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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