# FDA recall Z-1612-2023

> **Stryker Sustainability Solutions** · Class II · device recall initiated 2023-04-14.

## Product

REF 5065, Kendall, Impad Rigid Sole Foot Cover, Regular Pair ,<12", Rx Only Non-Sterile

## Reason for recall

Through complaint surveillance, it was identified that reprocessed Deep vein thrombosis (DVT) Compression Sleeves may be  mislabeled and/or mispackaged.

## Distribution

US: WA OUS: None

## Key facts

- **Recall number:** Z-1612-2023
- **Recalling firm:** Stryker Sustainability Solutions
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-04-14
- **Report date:** 2023-05-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tempe, AZ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1612-2023

## Citation

> AI Analytics. FDA recall Z-1612-2023. Retrieved 2026-07-17 from https://api.ai-analytics.org/recall/Z-1612-2023. Source: US FDA. Licensed CC0.

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