Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 14, 2018
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cau…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microline Surgical, Inc. recalled The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic … - a moderate-severity action.
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic … was recalled by Microline Surgical, Inc. in February 14, 2018. Reason: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs,…. Check the official notice for the remedy. Verify recall #Z-0507-2018 with the FDA Devices before acting.
The recall
Microline Surgical, Inc. issued this moderate-severity FDA Devices recall-The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs,….
- Moderate
- severity level
- 62K units
- affected scope
- Class II
- classification
- February 14, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0507-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0507-2018) was formally reported on February 14, 2018, with the manufacturer initiating the action on July 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Microline Surgical, Inc. is listed as the recalling firm, operating out of Beverly, MA. Federal records list the affected scope as 61,769 units.
The documented reason for this recall is: The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for… Distribution data in the federal record shows the product reached: Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Ta…. 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
61,769 units
Related Recalls
6
3 from same agency
Product description
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.
Reason for recall
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0507-2018 |
| Date reported | February 14, 2018 |
| Date initiated | July 13, 2017 |
| Recalling firm | Microline Surgical, Inc. |
| Firm location | Beverly, MA |
| Affected scope | 61,769 units |
| Distribution | Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Urug… |
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-0507-2018) 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? ▼
The ReNew Reusable Grasper and Dissector Tips are to be used with the ReNew Laparoscopic Handpieces and they are indicated for cutting, grasping, dissecting, and coagulation of tissue in endoscopic and laparoscopic surgical procedures.. Recalled by Microline Surgical, Inc.. Units affected: 61,769 units.
Why was this product recalled? ▼
The heat-shrink insulation tube may split during autoclave sterilization/re-sterilization. If a split occurs, the heat-shrink could fall off during a surgical procedure and if cautery is needed, there is a potential for burn due to insulation failure.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2018. Severity: Moderate. Recall number: Z-0507-2018.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-US (Nationwide) and countries of: Australia, Brazil, Canada, Chile, China, Colombia, El Salvador, Hong Kong, India, Indonesia, Malaysia, Mexico, Panama, Peru, Argentina, South Korea, Sri Lanka, Taiwan, Thailand, Uruguay & Vietnam..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0507-2018) 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 February 14, 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.