Severity
Low
FDA Devices recall · Reported June 17, 2015
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
Acclarent, Inc. recalled RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus… - a low-severity action.
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus… was recalled by Acclarent, Inc. in June 17, 2015. Reason: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.. Check the official notice for the remedy. Verify recall #Z-1740-2015 with the FDA Devices before acting.
The recall
Acclarent, Inc. issued this low-severity FDA Devices recall-Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date..
Sourced from official FDA Devices enforcement records. Verify recall #Z-1740-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
This FDA Devices action (record #Z-1740-2015) was formally reported on June 17, 2015, with the manufacturer initiating the action on April 28, 2015. It is classified under Low severity (Class III), with a current status of Terminated. Acclarent, Inc. is listed as the recalling firm, operating out of Menlo Park, CA. Federal records list the affected scope as 986.
The documented reason for this recall is: Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date. Distribution data in the federal record shows the product reached: US in the state of Texas. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Severity
Low
Affected scope
986
Related Recalls
6
3 from same agency
RELIEVA FLEX Sinus Guide Catheter F-70. Catalog number GC070RF. Product Usage - Sinus Catheter - Intended to provide a means to access the sinus space for diagnostic and therapeutic procedures. .
Acclarent determined that one single RELIEVA FLEX Sinus Guide Catheter was distributed past it's expiry date.
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1740-2015 |
| Date reported | June 17, 2015 |
| Date initiated | April 28, 2015 |
| Recalling firm | Acclarent, Inc. |
| Firm location | Menlo Park, CA |
| Affected scope | 986 |
| Distribution | US in the state of Texas |
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 17, 2015. 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.