Severity
Moderate
FDA Devices recall · Reported May 3, 2017
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the…
Stryker Instruments Div. of Stryker Corporation recalled Stryker SmartLife Large Aseptic Housing (7126-120-000) - a moderate-severity action.
Stryker SmartLife Large Aseptic Housing (7126-120-000) was recalled by Stryker Instruments Div. of Stryker Corporation in May 3, 2017. Reason: Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLi…. Check the official notice for the remedy. Verify recall #Z-1886-2017 with the FDA Devices before acting.
The recall
Stryker Instruments Div. of Stryker Corporation issued this moderate-severity FDA Devices recall-Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLi….
Sourced from official FDA Devices enforcement records. Verify recall #Z-1886-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1886-2017) was formally reported on May 3, 2017, with the manufacturer initiating the action on February 28, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Instruments Div. of Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records list the affected scope as 302.
The documented reason for this recall is: Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing … Distribution data in the federal record shows the product reached: Domestic: None Foreign: France, Germany. 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
302
Related Recalls
6
3 from same agency
Stryker SmartLife Large Aseptic Housing (7126-120-000)
Stryker Instruments issued a notice of correction for an update to cleaning practices for the Stryker SmartLife Large Aseptic Housings following complaints of deterioration to the housing and the top and bottom housing separating at the weld. Using cleaning practices outside of the HIFU could lead to housing separating at the weld.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1886-2017 |
| Date reported | May 3, 2017 |
| Date initiated | February 28, 2017 |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation |
| Firm location | Portage, MI |
| Affected scope | 302 |
| Distribution | Domestic: None Foreign: France, Germany |
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 May 3, 2017. 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.