CLASS II ONGOING Device recall · Reported 19 Aug 2026 · FDA Enforcement Report
Dermalon 88861757-31 Dermalon* 4-0 Blu C13 recalled by Covidien
Covidien is recalling Dermalon 88861757-31 Dermalon* 4-0 Blu C13 88861757-31 88861799-31 Dermalon* 4-0 Blu C14, distributed nationwide in the US. The recall was initiated on 24 Jun 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2920-2026
- FDA event ID
- 99390
- Recalling firm
- Covidien, North Haven, CT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 24 Jun 2026
- FDA classified
- 7 Aug 2026
- Reported
- 19 Aug 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 24 Jun 2026 | Recall initiated by company | |
| 7 Aug 2026 | Classified by FDA | +44 days |
| 19 Aug 2026 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 88861757-31 88861799-31 DERMALON* 4-0 BLU 75CM C14 88861799-31
Where it was distributed
US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
Questions about this recall
Is Dermalon 88861757-31 Dermalon* 4-0 Blu C13 88861757-31 88861799-31 Dermalon* 4-0 Blu C14 recalled?
Yes. Covidien recalled Dermalon 88861757-31 Dermalon* 4-0 Blu C13 88861757-31 88861799-31 Dermalon* 4-0 Blu C14 on 24 Jun 2026. The recall is Class II and its status is Ongoing. Recall number Z-2920-2026.
Why was it recalled?
Product may contain a perforation or tear in the sterile barrier packaging. This issue may result in biocontamination of the sterile sutures, which may lead to infection, loss of vision if in ophthalmic utilization, or prolonged surgery.
Which lots are affected?
88861757-31 UDI-DI 10884521070912 Lot D6A3020FY UDI-DI 20884521070919 Lot D6A3020FY 88861799-31 UDI-DI 20884521071060 Lot D6A2861FY
Where was it sold?
US Nationwide and the countries of Australia, Austria, Belgium, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Guadeloupe, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Japan, Kosovo, Lebanon, Lithuania, Luxembourg, Mexico, Namibia, Netherlands, North Macedonia, Northern Ireland, Norway, Oman, Panama, Poland, Portugal, Qatar, Reunion, Romania, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Ukraine, United Arab Emirates, United Kingdom, Uzbekistan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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