Hidrex USA DP450 Medical Device Recalled for Documentation Requirements
Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 device because it was reclassified from Class III to Class II, triggering new documentation requirements.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
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 reclassification and documentation requirements rather than a safety hazard, injury, or illness, fitting the 'documentation issues' criterion for a Low severity score.
Plain-English summary
Hidrex GmbH is recalling 64 units of the Hidrex USA DP450 medical device. The recall was initiated because the device was reclassified from a Class III device to a Class II device, which introduced new documentation requirements.
The affected units were distributed nationwide throughout the US. The specific serial numbers involved in this recall range from 16-3.7091 to 16-3.7134 and from 17-3.7001 to 17-3.7020.
Consumers and healthcare providers should check their inventory for these specific serial numbers. No specific consumer action instructions beyond identifying the affected units are provided in the source text.
The recalled product
- Product
- Hidrex USA DP450
- Manufacturer
- Hidrex GmbH
- Category
- Medical Device — Dermatology
- Hazard
- Affected units
- 64
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# 16-3.7091 to 16-3.7134
- 17-3.7001 to 17-3.7020
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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