Box as labeled: Regard, Carter-Thomason CloseSure System… recallZ-0985-2024 · CooperSurgical, Inc. · initiated Aug 29, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect component descriptions within the "Contents" section on the Tyvek lid for individual kit trays.
FDA root cause category: Labeling Change Control
What the company is doing
An Urgent Medical Device Field Safety Notice dated August 29, 2023 was sent to the one distributor receiving shipments of the affected product lot. Customers are advised to complete the acknowledgement form, Affected product is to be returned to CooperSugical for credit. Contact CooperSurgical at +1-203-601-5200 extension 3300 during normal operating hours of 09:00 - 17:00 M-F EST, email [email protected].
Recall details
- Recall number
- Z-0985-2024
- Status
- Open, Classified
- Initiated by the company
- Aug 29, 2023
- Posted by the FDA
- Feb 5, 2024
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 127 boxes, 3 kits per box (381 kits total)
- Product code
- GCJ
- FDA submissions
- K980123
- Distribution
- US Nationwide distribution in the state of MO.
Product description
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.
Code information (models, lots, serial numbers)
UDI-DI: 60888937027053, lot# 326728.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Carter-thomason CloseSure System XL (REGARD Distributed) 733776Coopersurgical, Inc. · Laparoscope, General & Plastic Surgery1 recall0 reports
Other devices under the same FDA submission
2 devices cleared under K980123 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Carter-Thomason CTI-512NCoopersurgical, Inc. · Laparoscope, General & Plastic Surgery2 reports
- Carter-Thomason II Port Closure System CTI-1015PCoopersurgical, Inc. · Laparoscope, General & Plastic Surgery2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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