Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported April 18, 2018
Doyen-Collin Mouth Gag 120MM/ General Instruments
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Aesculap Implant Systems LLC recalled Doyen-Collin Mouth Gag 120MM/ General Instruments - a low-severity action.
Doyen-Collin Mouth Gag 120MM/ General Instruments was recalled by Aesculap Implant Systems LLC in April 18, 2018. Reason: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing renderin…. Check the official notice for the remedy. Verify recall #Z-1358-2018 with the FDA Devices before acting.
The recall
Aesculap Implant Systems LLC issued this low-severity FDA Devices recall-The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing renderin….
- Low
- severity level
- Class III
- classification
- April 18, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1358-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-1358-2018) was formally reported on April 18, 2018, with the manufacturer initiating the action on February 16, 2018. It is classified under Low severity (Class III), with a current status of Terminated. Aesculap Implant Systems LLC is listed as the recalling firm, operating out of Center Valley, PA. The number of affected units is not disclosed in the agency filing, which is common for drug and food recalls where lot-level tracking supersedes unit counts.
The documented reason for this recall is: The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable. Distribution data in the federal record shows the product reached: nationwide. 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 low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
Unknown
Related Recalls
6
3 from same agency
Product description
Doyen-Collin Mouth Gag 120MM/ General Instruments
Reason for recall
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-1358-2018 |
| Date reported | April 18, 2018 |
| Date initiated | February 16, 2018 |
| Recalling firm | Aesculap Implant Systems LLC |
| Firm location | Center Valley, PA |
| Affected scope | Not disclosed |
| Distribution | nationwide |
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-1358-2018) 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? ▼
Doyen-Collin Mouth Gag 120MM/ General Instruments. Recalled by Aesculap Implant Systems LLC.
Why was this product recalled? ▼
The plastic sleeves of the Penis Clamp and Mouth Gag may stick together during or after reprocessing rendering the instruments unusable.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Low. Recall number: Z-1358-2018.
Where was the recalled product distributed? ▼
Distribution: nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1358-2018) 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 April 18, 2018. 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.