Severity
Moderate
FDA Devices recall · Reported August 7, 2019
Potential for product not to be sterile.
Teleflex Medical recalled Rusch EasyCath Kit - a moderate-severity action.
Rusch EasyCath Kit was recalled by Teleflex Medical in August 7, 2019. Reason: Potential for product not to be sterile.. Check the official notice for the remedy. Verify recall #Z-2086-2019 with the FDA Devices before acting.
The recall
Teleflex Medical issued this moderate-severity FDA Devices recall-Potential for product not to be sterile..
Sourced from official FDA Devices enforcement records. Verify recall #Z-2086-2019 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-2086-2019) was formally reported on August 7, 2019, with the manufacturer initiating the action on July 1, 2019. It is classified under Moderate severity (Class II), with a current status of Terminated. Teleflex Medical is listed as the recalling firm, operating out of Morrisville, NC. Federal records list the affected scope as 3,700 devices.
The documented reason for this recall is: Potential for product not to be sterile. Distribution data in the federal record shows the product reached: Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX.. 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
3,700 devices
Related Recalls
6
3 from same agency
Rusch EasyCath Kit
Potential for product not to be sterile.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2086-2019 |
| Date reported | August 7, 2019 |
| Date initiated | July 1, 2019 |
| Recalling firm | Teleflex Medical |
| Firm location | Morrisville, NC |
| Affected scope | 3,700 devices |
| Distribution | Nationwide distribution to CA, FL, IL, NC, NJ, OH, OK, TX. |
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 August 7, 2019. 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.