Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported November 28, 2012
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gyrus Acmi, Incorporated recalled PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GY… - a moderate-severity action.
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GY… was recalled by Gyrus Acmi, Incorporated in November 28, 2012. Reason: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene …. Check the official notice for the remedy. Verify recall #Z-0411-2013 with the FDA Devices before acting.
The recall
Gyrus Acmi, Incorporated issued this moderate-severity FDA Devices recall-One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene ….
- Moderate
- severity level
- Class II
- classification
- November 28, 2012
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0411-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0411-2013) was formally reported on November 28, 2012, with the manufacturer initiating the action on October 17, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. Gyrus Acmi, Incorporated is listed as the recalling firm, operating out of Southborough, MA. Federal records list the affected scope as 10 boxes/60 units.
The documented reason for this recall is: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. Distribution data in the federal record shows the product reached: Worldwide distribution: USA state of Kansas and country of Korea.. 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.
Medical Devices recalls over time
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.
Affected scope
10 boxes/60 units
Related Recalls
6
3 from same agency
Product description
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Reason for recall
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0411-2013 |
| Date reported | November 28, 2012 |
| Date initiated | October 17, 2012 |
| Recalling firm | Gyrus Acmi, Incorporated |
| Firm location | Southborough, MA |
| Affected scope | 10 boxes/60 units |
| Distribution | Worldwide distribution: USA state of Kansas and country of Korea. |
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.
- Check the recall number (Z-0411-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
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.
Frequently Asked Questions
What product was recalled? ▼
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube. Recalled by Gyrus Acmi, Incorporated. Units affected: 10 boxes/60 units.
Why was this product recalled? ▼
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 28, 2012. Severity: Moderate. Recall number: Z-0411-2013.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution: USA state of Kansas and country of Korea..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0411-2013) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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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 November 28, 2012. 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.