Data Foundry

Medical device recalls 2021

Proform- support surface is used to assist in the prevention and… — Class II medical device recall Z-2211-2021

Ongoing recall by Stryker Medical Division of Stryker Corporation, reported 2021-08-18, distributed nationwide. Medical devices intended for use in a healthcare facility were distributed to residential customers and may be

Recall numberZ-2211-2021
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmStryker Medical Division of Stryker Corporation, Portage, MI, United States
Recall initiated2021-05-12
Classified2021-08-06
Reported by FDA2021-08-18
DistributedNationwide (US)
Countries outside the USAR, BR, CA, CL, CO, IN, MX, TH
Quantity1 units
Reason classeslabeling
Serial numbers111427102713678
Model numbers2710

Product

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

Reason for recall

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

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2211-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.