Stryker Recalls AC Power Adaptors for Restep DVT System
Stryker is recalling AC Power Adaptors for the Restep DVT System because wires may come loose, preventing the unit from operating.
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 classified as FDA Class II. The hazard is a functional failure (wires coming loose) that prevents operation, but the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall.
Plain-English summary
Stryker Sustainability Solutions is recalling AC Power Adaptors (RSP159-01) and Pump Kits (PUMPKIT) used with the Restep Deep Vein Thrombosis (DVT) System. The recall involves 1,311 units distributed in Arizona and New Jersey.
The recall was initiated due to reports that the AC Power Adaptor may not operate because wires inside the unit can come loose. This defect prevents the external compression system from functioning as intended.
Affected units are identified by the following codes: 108851407, 108851408, 108870192, 108874144, 108883271, 108886340, and 108888023. Users should stop using the affected power adaptors and contact Stryker Sustainability Solutions for instructions on obtaining a replacement or repair.
The recalled product
- Product
- STRYKER Sustainability Solutions, AC Power Adaptor for Restep Deep Vein Thrombosis (DVT) System, an external compression system. PUMPKIT (Pump Kit), and RSP159-01 (AC Power Adaptor).
- Manufacturer
- Stryker Sustainability Solutions
- Affected units
- 1,311
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 (7)
- 108851407
- 108851408
- 108870192
- 108874144
- 108883271
- 108886340
- and 108888023.
Distribution
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