The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2360-2019·Announced 2019-09-04

Leventon DOSI-FUSER Infusion Pumps Recalled for Lack of FDA Clearance

Leventon S. A. U. is recalling DOSI-FUSER infusion pumps because they lack FDA 510(k) clearance, making them misbranded.

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 2/5 (Moderate).

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: The recall is driven by a regulatory compliance issue (lack of 510(k) clearance) rather than a reported safety hazard or injury, fitting the criteria for minor labeling or documentation issues.

Plain-English summary

Leventon S. A. U. is recalling approximately 1,700 units of DOSI-FUSER 12591 5-500D1 and 12591 5-600D1 infusion pumps. These devices are designed to provide parenteral drug infusions at a constant flow without impeding patient mobility.

The recall is being conducted because the product lacks FDA 510(k) clearance. As a result, the devices are considered misbranded and must be removed from the U.S. market. The agency classification for this recall is Class II.

The affected units were distributed to Arizona, California, Massachusetts, Michigan, Puerto Rico, and Florida. Specific lot codes and Unique Device Identifiers (UDIs) are listed in the official recall record. Consumers and healthcare facilities should stop using these devices and contact the manufacturer for instructions on removal or return.

The recalled product

Product
DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
Manufacturer
Leventon S. A. U.
Category
Medical Device — Infusion Pumps
Hazard
Affected units
1,700

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 (5)

  • 172055L
  • 1721 10L
  • 1 807881
  • 181 1401 Unique Device Identifier (UDI) 08436020767470
  • 08436020768026

Distribution

Distributed in 6 states:

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