Home › Device types › GDW
Staple, Implantable
FDA product code GDW · Class 2 · General, Plastic Surgery
856
Registered devices
169,610
Adverse events
225
Recalls
283
510(k) clearances
Devices with this code
Linear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd.Roticulator 55 Poly — Covidien LPTri-Staple 2.0 — Covidien LPECHELON FLEX — ETHICON ENDO-SURGERY, LLCOPTIFIX — Davol Inc.CONTOUR — ETHICON ENDO-SURGERY, LLCUltraClip® II Breast Tissue Marker — Bard Peripheral Vascular, Inc.easyLCTM Linear Cutter Staplers and Loading Units for Single Use — Ezisurg Medical Co., Ltd.AEON — LEXINGTON MEDICAL, INC.Endo GIA — Covidien LPDisposable Endoscopic Linear Cutter Staplers and Reloads — Sinolinks Medical Innovation Co., Ltd.ENDOPATH — ETHICON ENDO-SURGERY, LLCcutter stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd.Signia — Covidien LPTA Premium — Covidien LPeasyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use — Ezisurg Medical Co., Ltd.TA — Covidien LPTA Premium — Covidien LPEEA — Covidien LPReloading Unit for Endo Linear Cutter Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd.Single Use Circular Stapler — Golden Stapler Surgical Co.,LtdeasyCSTM Circular Stapler for Single Use — Ezisurg Medical Co., Ltd.EEA — Covidien LPLinear Stapler — B. J. ZH. F. Panther Medical Equipment Co., Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-09-25 | Covidien, LP | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for un |
| 2025-09-25 | Covidien, LP | A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for un |
| 2025-09-11 | Ethicon Endo-Surgery Inc | The devices were shipped unsterilized. |
| 2025-04-22 | Ethicon Endo-Surgery Inc | Firm has received an increase in reports regarding inadvertent instrument lockout during surgical procedures involving the device. If lockout occurs, the device |
| 2024-08-12 | Smith & Nephew Inc. | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-08-12 | Smith & Nephew Inc. | Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility |
| 2024-04-15 | Covidien, LP | Potential damage to the cartridge can result in poor staple formation and/or incomplete staple line, may cause a delay in surgery |
| 2024-02-14 | Covidien, LP | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is rela |
| 2024-02-14 | Covidien, LP | Under certain firing conditions, reloads were found to articulate in an uncontrolled manner potentially causing disruption to the staple line. The issue is rela |
| 2023-12-11 | Ethicon Endo-Surgery Inc | There is the potential for incomplete staple line formation during the firing sequence, without most or all staples, which may lead to insufficient tissue appos |
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