Covidien EndoStitch Polysorb Loading Units Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Covidien, LP is recalling 2448 units of EndoStitch Polysorb Single Use Loading Units due to holes in the pouch that may compromise sterility.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 11, 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, device.
What Happened
The presence of holes in the pouch may compromise the package's ability to maintain the sterile barrier and protect the product from environmental exposure.
Which Products Are Affected
Covidien EndoStitch Polysorb Single Use Loading Unit, product numbers 170053 and 170071. Affected lots are J5L2332Y (product 170053, UDI-DI 10884521126732) and J5H2924Y (product 170071, UDI-DI 10884521126787). A total of 2448 units are involved. Distribution was nationwide in the United States and to Austria, Canada, Denmark, France, and Italy.
What You Should Do
Check product numbers and lot codes against the recalled units. Contact the recalling firm for return or replacement instructions.
Why This Matters
The Class II recall involves sterile medical devices distributed across the United States and multiple international markets.
Source
FDA recall number Z-2281-2026, initiated by Covidien, LP on 20260415.
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 (934 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.