AVID TruCustom recallZ-1743-2025 · AVID Medical, Inc. · initiated Mar 31, 2025
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 AVID Medical, 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
An issue with a raw material used to coat some surgical needles that may result in diminished performance and/or removal of some silicone needle coating during use.
FDA root cause category: Nonconforming Material/Component
What the company is doing
An URGENT: MEDICAL DEVICE RECALL NOTIFICATION dated 3/31/25 was emailed to consignees. The notification indicates that this recall is due to Ethicon having recalled PDS II, PDS Plus, PROLENE, and ATHIBOND EXCEL sutures, which are components in the convenience kits being recalled by the recalling firm. Consignees are being instructed to discontinue use of the Johnson & Johnson Ethicon Sutures contained inside the recalled AVID kits identified in the recall notification and to add the provided labels to affected kits to ensure recalled sutures are discarded. Distributors are asked to forward the provided recall notification to their customers to which product was further distributed. Consignees are asked to return the provided response form via email. Questions regarding this recall event are to be directed to your distributor or sales representative.
Recall details
- Recall number
- Z-1743-2025
- Status
- Open, Classified
- Initiated by the company
- Mar 31, 2025
- Posted by the FDA
- May 9, 2025
- Recalling firm
- AVID Medical, Inc.
- Quantity
- 72 units
- Product code
- OEZ
- Distribution
- US Nationwide distribution in the states of IL & LA.
Product description
Halyard RAPIDES E-PACK. Cardiovascular Procedure Convenience Kit.
Code information (models, lots, serial numbers)
Model No. RPGH9472-01; UDI: 10809160211311; Lot Code: Lot: 1636640; Exp: 1/13/2028.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- AVID TruCustom RPGH9472-01_0002Avid Medical, Inc. · Cardiovascular procedure kit1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 96731).
- Z-1741-2025 · Open, ClassifiedHalyard CHRIST SUTURE KIT. General Procedure Tray Convenience Kit
- Z-1742-2025 · Open, ClassifiedHalyard SUTURE PACK CABG. Cardiovascular Procedure Convenience Kit.
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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