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N/A (REF 5065)Recalls & reported problems

Stryker Sustainability Solutions, Inc. · Compression Sleeve Rigid Sole Foot Cover · Class 2

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
0
Deaths reported
0
Injuries reported
0
Recalls naming it
1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

  1. Apr 14, 2023Open, Classified

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

    Z-1612-2023 · Root cause: Under Investigation by firm · FDA record ↗

Other SLEEVE, LIMB, COMPRESSIBLE devices

All SLEEVE, LIMB, COMPRESSIBLE devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.