Covidien Dermalon Sutures Recall Due to Packaging Defect
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Covidien, LP is recalling 135,875 units of Dermalon sutures because the sterile barrier packaging may contain a perforation or tear.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on August 26, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Covidien, LP initiated a voluntary recall of certain Dermalon sutures after determining that the 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 Products Are Affected
The recall covers Dermalon 88861757-31 DERMALON* 4-0 BLU 75CM C13 and 88861799-31 DERMALON* 4-0 BLU 75CM C14. Affected lots include D6A3020FY (UDI-DI 10884521070912, 20884521070919) and D6A2861FY (UDI-DI 20884521071060). A total of 135,875 units are affected. The products were distributed nationwide in the United States and to 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, and Uzbekistan. The recall number is Z-2920-2026 and it is classified as Class II.
What You Should Do
The recalling firm notified customers via letter. No additional consumer instructions are provided in the recall notice.
Why This Matters
The potential for biocontamination from compromised sterile packaging poses a risk of infection or other complications during surgical use.
Source
FDA recall Z-2920-2026 (event ID 99390), initiated June 24, 2026.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (1,792 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to August 26, 2026.
Frequently Asked Questions
Common questions about this FDA recall.