Data Foundry

Medical device recalls 2020

Stryker IsoAir 2 — Class II medical device recall Z-3015-2020

Terminated recall by Stryker Medical Division of Stryker Corporation, reported 2020-10-07, distributed nationwide. Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR

Recall numberZ-3015-2020
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmStryker Medical Division of Stryker Corporation, Portage, MI, United States
Recall initiated2020-08-12
Classified2020-09-25
Reported by FDA2020-10-07
Terminated2021-04-02
DistributedNationwide (US)
Quantity110 units
UPC / GTIN / UDI-DI02020018700103, 02020018700110, 02020018700127, 02020018700134, 02020018700141, 02020018700158, 02020018700240, 02020018700257, 02020018700264, 02020018700288, 07613327503999
Serial numbers2020018700101, 2020018700102, 2020018700103, 2020018700104, 2020018700105, 2020018700106, 2020018700107, 2020018700108, 2020018700109, 2020018700110, 2020018700111, 2020018700112, 2020018700113, 2020018700114, 2020018700115, 2020018700116, 2020018700117, 2020018700118, 2020018700119, 2020018700120, 2020018700121, 2020018700122, 2020018700123, 2020018700124, 2020018700125 and 85 more
Model numbers2941-001-100

Product

Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to assist in management of the microclimate of the patient skin, Model Number: 2941-001-100

Reason for recall

Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CPR connector causing a delay in resuscitation efforts for patients experiencing cardiac arrest and needing CPR

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-3015-2020. 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.