Microline ReNew Surgical Tips Recall: Heat-Shrink Tube May Split During Sterilization
Microline recalls ReNew reusable grasper and dissector tips used with laparoscopic handpieces due to risk of heat-shrink tube splitting during autoclave sterilization, potentially causing burns during surgery.
Use caution until it’s fixed
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.
Contact the company
What happened, in plain English
Microline is recalling reusable surgical tips that may split during sterilization, creating a risk of burns if used during surgery. This affects specific product codes and requires immediate attention to prevent injury. Read more at govinfonow.com/recall/73428-microline-renew-surgical-tips-recall-heat-shrink-tube-may-split.
Source Summary by GovInfoNow · govinfonow.com/recall/73428-microline-renew-surgical-tips-recall-heat-shrink-tube-may-split · Updated September 21, 2026 · FDA enforcement record: FDA #Z-0507-2018
Cite this page
“Microline ReNew Surgical Tips Recall: Heat-Shrink Tube May Split During Sterilization.” GovInfoNow, updated September 21, 2026. https://govinfonow.com/recall/73428-microline-renew-surgical-tips-recall-heat-shrink-tube-may-split. Based on FDA recall #Z-0507-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0507-2018%22&limit=1).
Why it’s dangerous
The heat-shrink insulation tube can split during repeated autoclave sterilization cycles. If it splits, the tube may detach during surgery. If cautery is needed, the exposed electrical components could cause burns due to insulation failure.
Who’s affected
Surgical teams using Microline ReNew laparoscopic handpieces with the recalled tips. Patients undergoing surgery with these tips are at risk of burns if the heat-shrink tube fails during cautery.
How to tell if you have this one
Check for product codes 3201 through 3431 on the tips. The UDI (unique device identifier) codes are listed in the recall notice for these specific lots.
- Brand
Microline- Category
Medical device
What to do — step by step
Check Product Codes
Identify if your tips have product codes 3201 through 3431.
Contact Manufacturer
Reach out to Microline Surgical, Inc. for specific guidance on handling recalled items.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
FDA 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,…” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA terminated this recall 2.6 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Do I need to stop using these tips immediately?
The recall does not require immediate discontinuation but requires checking product codes and contacting Microline for guidance.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0507-2018 (July 13, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0507-2018 to see it in context.
- Plain-language summary written by qwen3:4b on September 21, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.