Home › Device types › EFQ
Gauze/Sponge, Internal
FDA product code EFQ · Class U · Unknown
474
Registered devices
297
Adverse events
13
Recalls
271
510(k) clearances
Devices with this code
36M - State of Colorado DOT - Med Facility — Certified Safety Manufacturing, Inc.A Plus — A PLUS INTERNATIONAL INC.FAC-4 - Miller & Long Concrete — Certified Safety Manufacturing, Inc.75V - UP Facilities — Certified Safety Manufacturing, Inc.622 - Certi-Gauze Bandage Compress - 2" - 4/Unit — Certified Safety Manufacturing, Inc.36M - Class A Select - Metal — Certified Safety Manufacturing, Inc.A Plus — A PLUS INTERNATIONAL INC.Curity — Cardinal Health 200, LLCCerti-Gauze Pads - 3"x 3" - 10/Box — Certified Safety Manufacturing, Inc.A Plus — A PLUS INTERNATIONAL INC.V. Mueller — STERIS CORPORATION24M - Tampa Electric Co. — Certified Safety Manufacturing, Inc.MEROCEL® — MEDTRONIC XOMED, INC.Sports Bag - Fanny Pack — Certified Safety Manufacturing, Inc.MEROCEL® — MEDTRONIC XOMED, INC.16PW - Century Link - Poly Green — Certified Safety Manufacturing, Inc.Merocel™ — MEDTRONIC XOMED, INC.FAC-3 - School Nurse Supply — Certified Safety Manufacturing, Inc.16PW - Los Alamos - Poly White — Certified Safety Manufacturing, Inc.FABCO — FIRST AID BANDAGE CO INCZLB - BBP/FA - Bonneville Power - Personal Protection - Refill — Certified Safety Manufacturing, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.36M - UP Facilities - Metal — Certified Safety Manufacturing, Inc.A Plus — A PLUS INTERNATIONAL INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-08 | AMD Medicom Inc. | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c |
| 2026-05-08 | AMD Medicom Inc. | Neurological sponges used to moisten or absorb biological fluid during neurological surgery and may also be used to protect the brain during incision, may not c |
| 2026-05-07 | TELEFLEX LLC | Due to out-of-specification, or potential out-of-specification, levels of endotoxins |
| 2022-09-28 | TELEFLEX LLC | Specific lots have not been irradiated to eliminate pyronema and therefore the sterility of the affected products may be compromised. |
| 2022-03-22 | Steris Corporation | Product not approved for release for US distribution |
| 2022-03-22 | Steris Corporation | Product not approved for release for US distribution |
| 2020-11-09 | ROi CPS LLC | Gauze sponges contained in custom kits may be flaking or fraying. |
| 2016-03-31 | American Surgical Company | Product packaging defective compromising sterility |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| 2015-07-10 | Customed, Inc | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
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