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.
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 3/5 (High).
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
- Affected units
- 50
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:
Related recalls
Same manufacturer · Stryker Sustainability Solutions
See all →- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocars Due to Cracking Risk
FDA (Devices) · 2026-09-23
- HighStryker Recalls XCEL Bladeless Trocar Due to Cracking Risk
FDA (Devices) · 2026-09-23
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighStryker Recalls 90 Reprocessed Zimmer Tourniquet Cuffs Due to Mislabeling
FDA (Devices) · 2020-05-06
- ModerateStryker Recalls Mislabeled VenaFlow Calf Compression Garments
FDA (Devices) · 2017-12-27
- ModerateStryker recalls mislabeled 5mm trocar sleeves due to length discrepancy
FDA (Devices) · 2015-09-02
- ModerateStryker Recalls Mislabeled Reprocessed Diagnostic Electrophysiology Catheters
FDA (Devices) · 2016-06-01
- HighReprocessed Electrophysiology Catheter with Incomplete Sterile Seals
FDA (Devices) · 2026-05-20
- HighReprocessed Electrophysiology Catheter Recalled for Incomplete Seals
FDA (Devices) · 2026-05-20