Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported October 29, 2014
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the s…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Gyrus Medical, Inc recalled GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Force… - a moderate-severity action.
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Force… was recalled by Gyrus Medical, Inc in October 29, 2014. Reason: Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may al…. Check the official notice for the remedy. Verify recall #Z-0100-2015 with the FDA Devices before acting.
The recall
Gyrus Medical, Inc issued this moderate-severity FDA Devices recall-Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may al….
- Moderate
- severity level
- Class II
- classification
- October 29, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0100-2015 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0100-2015) was formally reported on October 29, 2014, with the manufacturer initiating the action on August 27, 2014. It is classified under Moderate severity (Class II), with a current status of Terminated. Gyrus Medical, Inc is listed as the recalling firm, operating out of Osseo, MN. Federal records list the affected scope as 5520 US, 40 OUS.
The documented reason for this recall is: Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA.. 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
5520 US, 40 OUS
Related Recalls
6
3 from same agency
Product description
GYRUS ACMI, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.
Reason for recall
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0100-2015 |
| Date reported | October 29, 2014 |
| Date initiated | August 27, 2014 |
| Recalling firm | Gyrus Medical, Inc |
| Firm location | Osseo, MN |
| Affected scope | 5520 US, 40 OUS |
| Distribution | Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA. |
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-0100-2015) 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, REF 3345 -Everest BiCOAG MOLly Forceps 5mm/45cm REF 3345PK - PKS MOLly Forceps 5mm/45cm REF 3640 -Everest BiCOAG Macro Jaw Forceps 5mm/45cm REF 3640PK- PKS Macro Jaw Forceps 5mm/45cm REF 3844- Everest BiCOAG LP Scissors 5mm/45cm REF 910010PK- PKS MOLly Forceps 5mm/45cm Single-use, sterile devices intended for the electrosurgical coagulation, mechanical grasping, and dissection of tissue during the performance of laparoscopic and general surgical procedures.. Recalled by Gyrus Medical, Inc. Units affected: 5520 US, 40 OUS.
Why was this product recalled? ▼
Due to an anomaly in the packaging process, it is possible that a defective seal could be present that may allow a breach of the package's sterile barrier and may compromise the sterility of the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 29, 2014. Severity: Moderate. Recall number: Z-0100-2015.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution - USA including US: AL, AZ, CA, FL, GA, HI, IL, IN, IA, KY, MA,MI,MS, NJ, NY, NC, OH, PA, SC, TN, UT, and WA. Internationally to ITALY, SPAIN, UNITED KINGDOM, and CHINA..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0100-2015) 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 October 29, 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.