Severity
Moderate
FDA Devices recall · Reported October 7, 2020
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 expe…
Stryker Medical Division of Stryker Corporation recalled Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to as… - a moderate-severity action.
Stryker IsoAir 2.0 support surface-provides pressure redistribution and is intended to as… was recalled by Stryker Medical Division of Stryker Corporation in October 7, 2020. Reason: Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CP…. Check the official notice for the remedy. Verify recall #Z-3015-2020 with the FDA Devices before acting.
The recall
Stryker Medical Division of Stryker Corporation issued this moderate-severity FDA Devices recall-Connector between support surface and pump may be out of tolerance resulting in difficulty in removing the CP….
Sourced from official FDA Devices enforcement records. Verify recall #Z-3015-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-3015-2020) was formally reported on October 7, 2020, with the manufacturer initiating the action on August 12, 2020. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Medical Division of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 110 units.
The documented reason for this recall is: 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 Distribution data in the federal record shows the product reached: US Nationwide distribution including in the states of CA, FL, NY, OH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Moderate
Affected scope
110 units
Related Recalls
6
3 from same agency
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
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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-3015-2020 |
| Date reported | October 7, 2020 |
| Date initiated | August 12, 2020 |
| Recalling firm | Stryker Medical Division of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 110 units |
| Distribution | US Nationwide distribution including in the states of CA, FL, NY, OH. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported October 7, 2020. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.