Home › Device types › GDY
Gauze/Sponge, Internal, X-Ray Detectable
FDA product code GDY · Class 1 · General, Plastic Surgery
1,470
Registered devices
2,553
Adverse events
66
Recalls
111
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.FABCO — FIRST AID BANDAGE CO INCAMD-RITMED — AMD Medicom IncArterial Line Kit — ARGON MEDICAL DEVICES, INC.SURGICOUNT — STRYKER CORPORATIONSyntervention — ZIEN MEDICAL TECHNOLOGIES, INC.Dermapac, Inc. — Dermapac Inc.AMD-RITMED — AMD Medicom IncORLocate — Steris CorporationDeRoyal — DEROYAL INDUSTRIES, INC.AMD-RITMED — AMD Medicom IncSymmetry SECTO® — ASPEN SURGICAL PRODUCTS, INC.AMD-RITMED — AMD Medicom IncBioseal Inc. — BIOSEALAMD-RITMED — AMD Medicom IncDukal — Dukal LLCTally Surgical Solution — Tally Surgical, Inc.Situate — Covidien LPAMD-RITMED — AMD Medicom IncPILLING — TELEFLEX INCORPORATEDCARDINAL HEALTH — Cardinal Health 200, LLCSituate — Covidien LPAMD-RITMED — AMD Medicom IncAmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANY
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2025-07-01 | Carefree Surgical Specialties | Due to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile packaging |
| 2024-02-21 | Covidien | Packs including 5 laparotomy sponges may contain incorrect product with a blue loop, X-ray detectable feature, and ethylene oxide treatment; however, this inco |
| 2022-01-24 | Argon Medical Devices, Inc | Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the pr |
| 2021-08-11 | Cypress Medical Products LLC | Manufacturer issued a recall due to an EO indicator color. The indicator should change from red to blue signifying sterilization. However, on one case of produc |
| 2020-04-08 | Argon Medical Devices, Inc | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The |
| 2020-04-08 | Argon Medical Devices, Inc | Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The |
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