Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2211-2021 — Proform- support surface is used to assist in the prevention and treatment of all categories/stages of pressure ulcers, Model Number: 2710, Part #¿2710000027¿¿¿¿

U.S. FDA — Device Enforcement · United States · 2021-05-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2211-2021
Date of alert
2021-05-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Medical Division of Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2710000027
Reported risk: Medical devices intended for use in a healthcare facility were distributed to residential customers and may be in use in a home environment. The product s labeling accurately identifies the correct use environment, but home users may not be aware of or fully understand these instructions intended for healthcare professionals
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.