Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Box as labeled: Regard Recalled by CooperSurgical, Inc. Due to Incorrect component descriptions within the "Contents" section on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact CooperSurgical, Inc. directly.
Affected Products
Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
Quantity: 127 boxes, 3 kits per box (381 kits total)
Why Was This Recalled?
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About CooperSurgical, Inc.
CooperSurgical, Inc. has 83 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report