Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported December 3, 2014
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead t…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gyrus Acmi, Incorporated recalled Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901… - a moderate-severity action.
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901… was recalled by Gyrus Acmi, Incorporated in December 3, 2014. Reason: All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging t…. Check the official notice for the remedy. Verify recall #Z-0419-2015 with the FDA Devices before acting.
The recall
Gyrus Acmi, Incorporated issued this moderate-severity FDA Devices recall-All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging t….
- Moderate
- severity level
- 75K units
- affected scope
- Class II
- classification
- December 3, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0419-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0419-2015) was formally reported on December 3, 2014, with the manufacturer initiating the action on October 21, 2014. 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 74,792 units.
The documented reason for this recall is: All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection. Distribution data in the federal record shows the product reached: Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe. 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
74,792 units
Related Recalls
6
3 from same agency
Product description
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).
Reason for recall
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0419-2015 |
| Date reported | December 3, 2014 |
| Date initiated | October 21, 2014 |
| Recalling firm | Gyrus Acmi, Incorporated |
| Firm location | Southborough, MA |
| Affected scope | 74,792 units |
| Distribution | Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe |
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-0419-2015) 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? ▼
Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude both Fallopian tubes without removing the applicator from the abdominal cavity. The Falope-Ring Band and Applicator Kits are indicated for use for female sterilization (permanent contraception).. Recalled by Gyrus Acmi, Incorporated. Units affected: 74,792 units.
Why was this product recalled? ▼
All packages of Falope Ring Band Applicator kits are being recalled due to compromises in sterile packaging that could be associated with bacterial contamination that might lead to patient infection.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 3, 2014. Severity: Moderate. Recall number: Z-0419-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide distribution. US Nationwide, Canada, Vietnam, and Europe.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0419-2015) 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 December 3, 2014. 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.