Severity
Moderate
FDA Devices recall · Reported June 21, 2017
Due to possibility of insufficient sterilization.
Applied Medical Resources Corp recalled Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Op… - a moderate-severity action.
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Op… was recalled by Applied Medical Resources Corp in June 21, 2017. Reason: Due to possibility of insufficient sterilization.. Check the official notice for the remedy. Verify recall #Z-2533-2017 with the FDA Devices before acting.
The recall
Applied Medical Resources Corp issued this moderate-severity FDA Devices recall-Due to possibility of insufficient sterilization..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2533-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2533-2017) was formally reported on June 21, 2017, with the manufacturer initiating the action on May 4, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Applied Medical Resources Corp is listed as the recalling firm, operating out of Rancho Santa Margarita, CA. Federal records list the affected scope as 7,939 units total (870 units in US).
The documented reason for this recall is: Due to possibility of insufficient sterilization. Distribution data in the federal record shows the product reached: US and worldwide: Australia, Finland, France, United Kingdom. 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
7,939 units total (870 units in US)
Related Recalls
6
3 from same agency
Kii Shielded Bladed trocars (CTB14), Kii Low profile trocars (CTB23), and Kii 5x55mm Optical Z-Thread Dual Pack (CTR14) trocars.
Due to possibility of insufficient sterilization.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2533-2017 |
| Date reported | June 21, 2017 |
| Date initiated | May 4, 2017 |
| Recalling firm | Applied Medical Resources Corp |
| Firm location | Rancho Santa Margarita, CA |
| Affected scope | 7,939 units total (870 units in US) |
| Distribution | US and worldwide: Australia, Finland, France, United Kingdom |
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 21, 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.