Reprocessed DVT Compression Sleeves Recalled Due to Labeling and Packaging Errors
Stryker Sustainability Solutions recalls reprocessed DVT compression sleeves that may be mislabeled or mispackaged. These prescription-only devices could be improperly identified or distributed due to packaging errors.
What this means for you
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 recall for mislabeling and mispackaging of prescription-only compression sleeves. Although no illnesses or injuries have been reported, this qualifies as a risk-of-harm product where improper labeling could affect patient safety, proper use, and regulatory compliance.
Plain-English summary
Stryker Sustainability Solutions has recalled reprocessed DVT (Deep Vein Thrombosis) compression sleeves, model REF 5065 (Kendall Impad Rigid Sole Foot Cover), due to mislabeling and mispackaging. The product is designated for prescription-only use.
The issue was identified through surveillance monitoring. Affected units may not bear the correct labeling or packaging, which could interfere with the product's prescription-only status and potentially compromise proper use and distribution.
This recall affects inventory distributed to Washington state. Affected lot number 0000157564 (UDI-DI: 00885825013585) comprises 50 units.
Healthcare providers and customers with this product should verify their inventory for the affected lot number and contact Stryker Sustainability Solutions for guidance on return or replacement options.
The recalled product
- Product
- REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile
- Manufacturer
- Stryker Sustainability Solutions
- Hazard
- mis-labeling
- mis-packaging
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)
- Lot # 0000157564
- UDI-DI: 00885825013585
Distribution
Distributed in 1 state:
- WA
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