Severity
Moderate
FDA Devices recall · Reported June 14, 2017
The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be i…
Stryker Communications recalled Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights … - a moderate-severity action.
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights … was recalled by Stryker Communications in June 14, 2017. Reason: The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the sn…. Check the official notice for the remedy. Verify recall #Z-2248-2017 with the FDA Devices before acting.
The recall
Stryker Communications issued this moderate-severity FDA Devices recall-The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the sn….
Sourced from official FDA Devices enforcement records. Verify recall #Z-2248-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2248-2017) was formally reported on June 14, 2017, with the manufacturer initiating the action on April 21, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Stryker Communications is listed as the recalling firm, operating out of Flower Mound, TX. Federal records list the affected scope as 57 units.
The documented reason for this recall is: The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause t… Distribution data in the federal record shows the product reached: Worldwide Distribution - US and Canada. 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
57 units
Related Recalls
6
3 from same agency
Berchtold Chromophare F300 Exam Light CHROMOPHARE examination lights are medical lights used for local illumination of the patients' body so that illnesses, injuries and disabilities can be diagnosed and treated
The exam light may have a tolerance issue with the adapter assembly, which could potentially not allow the snap ring to be seated correctly. If this is the case, there could be insufficient mount force that may cause the equipment to fall, resulting in serious injury.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2248-2017 |
| Date reported | June 14, 2017 |
| Date initiated | April 21, 2017 |
| Recalling firm | Stryker Communications |
| Firm location | Flower Mound, TX |
| Affected scope | 57 units |
| Distribution | Worldwide Distribution - US and Canada |
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 June 14, 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.