CooperSurgical CloseSure System XL: Incorrect Component Descriptions in Kit
CooperSurgical recalls CloseSure System XL kits with incorrect component descriptions on Tyvek lid. Affected kits may have missing parts; contact for replacement.
Lower-risk recall
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Contact the company
What happened, in plain English
CooperSurgical is recalling CloseSure System XL kits that have incorrect component descriptions on the Tyvek lid. This could mean users might not have the right parts for their procedure, which may lead to errors during use. Read more at govinfonow.com/recall/57431-coopersurgical-closesure-system-xl-incorrect-component-descriptions-in-kit.
Source Summary by GovInfoNow · govinfonow.com/recall/57431-coopersurgical-closesure-system-xl-incorrect-component-descriptions-in-kit · Updated August 17, 2026 · FDA enforcement record: FDA #Z-0985-2024
Cite this page
“CooperSurgical CloseSure System XL: Incorrect Component Descriptions in Kit.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/57431-coopersurgical-closesure-system-xl-incorrect-component-descriptions-in-kit. Based on FDA recall #Z-0985-2024 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0985-2024%22&limit=1).
Why it’s dangerous
The Tyvek lid labels for individual kit trays have incorrect component descriptions. This could lead to users not having the right parts for their procedure, potentially causing errors during surgery.
Who’s affected
Surgical teams using the CloseSure System XL kits with the specific reference number 733776 are affected. Those performing procedures requiring precise suture guidance are at higher risk.
How to tell if you have this one
Check for the reference number 733776 on the box. The kit includes one Carter-Thomason Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide.
- Brand
CooperSurgical- Category
Medical device
What to do — step by step
Check Kit Contents
Verify the kit includes one Carter-Thomason Suture Passer, one 5 mm Pilot Guide, and one 10/12 mm Pilot Guide.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “US Nationwide distribution in the state of MO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 6 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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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-0985-2024 (August 29, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0985-2024 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 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.