Hidrex USA DVP1000 Recalled Due to Documentation Requirements
Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device because it was reclassified from Class III to Class II, triggering new documentation requirements.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is driven by administrative documentation requirements following a regulatory reclassification, with no mention of safety hazards, injuries, or adverse health consequences, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Hidrex GmbH is recalling 180 units of the Hidrex USA DVP1000 device. The recall is being conducted because the device was reclassified from a Class III device to a Class II device, which has resulted in new documentation requirements.
The affected units were distributed nationwide throughout the US. The specific serial numbers involved in this recall range from 16-3.6190 to 16-3.6319 and from 17-3.6001 to 17-3.6050.
Consumers and healthcare providers should check their records for these specific serial numbers. If a unit matches the affected range, they should contact Hidrex GmbH for further instructions regarding the documentation requirements.
The recalled product
- Product
- Hidrex USA DVP1000
- Manufacturer
- Hidrex GmbH
- Category
- Medical Device — Dermatology
- Hazard
- Affected units
- 180
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)
- SN# 16-3.6190 to 16-3.6319
- 17-3.6001 to 17-3.6050
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Hidrex GmbH 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.
See all 3 products in this recall →Related recalls
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