Home › Device types › GAG
Stapler, Surgical
FDA product code GAG · Class 2 · General Hospital
221
Registered devices
27,034
Adverse events
10
Recalls
43
510(k) clearances
Devices with this code
Endo GIA Ultra — Covidien LPGIA — Covidien LPHenry Schein — HENRY SCHEIN, INC.Titan SGS Standard Gastric Stapler — STANDARD BARIATRICS, INCTitan SGS Standard Gastric Stapler — STANDARD BARIATRICS, INCGIA — Covidien LPECHELON — ETHICON ENDO-SURGERY, LLCEndo GIA — Covidien LPGIA — Covidien LPGIA — Covidien LPEEA — Covidien LPECHELON — ETHICON ENDO-SURGERY, LLCGIA — Covidien LPDeRoyal — DEROYAL INDUSTRIES, INC.Endo GIA — Covidien LPEndo GIA — Covidien LPECHELON — ETHICON ENDO-SURGERY, LLCMcKesson — MCKESSON MEDICAL-SURGICAL INC.SubQ It! — OPUS KSD, INC.EEA — Covidien LPEndo GIA — Covidien LPGIA — Covidien LPGIA — Covidien LPEEA — Covidien LP
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-05-13 | Covidien, LP | The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage an |
| 2019-07-01 | Intuitive Surgical, Inc. | The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which |
| 2019-07-01 | Intuitive Surgical, Inc. | The firm became aware of a manufacturing variation in which black and green reloads in select Stapler Reloads may not deploy individual adjacent staples, which |
| 2018-08-17 | COVIDIEN LLC | The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple for |
| 2014-08-12 | Ethicon Endo-Surgery Inc | The device may have a non-conforming component that may cause the device to fire an unformed staple. |
| 2013-05-03 | Surgical Instrument Service And Savings, Inc. | The seal which maintains a sterile barrier for reprocessed medical devices became compromised to the point where product may fall out of the pouch. |
| 2012-10-04 | Ethicon Endo-Surgery Inc | Damage to the packaging may have compromised the sterility of the device. |
| 2010-04-01 | Cardinal Health | The sterility of the staplers is questionable. |
| 2003-06-30 | Power Medical Interventions | latching mechanism failure |
| 2003-06-30 | Power Medical Interventions | latching mechanism failure |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.