Home › Device types › EFQ
Gauze/Sponge, Internal
FDA product code EFQ · Class U · Unknown
474
Registered devices
292
Adverse events
13
Recalls
271
510(k) clearances
Devices with this code
MEROCEL® — MEDTRONIC XOMED, INC.MEROCEL® — MEDTRONIC XOMED, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.16PW - PG&E - Poly White — Certified Safety Manufacturing, Inc.A Plus — A PLUS INTERNATIONAL INC.DeRoyal — DEROYAL INDUSTRIES, INC.FABCO — FIRST AID BANDAGE CO INCMerocel® ELVIS® — MEDTRONIC XOMED, INC.Merocel™ — MEDTRONIC XOMED, INC.Merocel™ — MEDTRONIC XOMED, INC.MEROCEL® — MEDTRONIC XOMED, INC.DeRoyal — DEROYAL INDUSTRIES, INC.DeRoyal — DEROYAL INDUSTRIES, INC.24M - Class A Select - Metal — Certified Safety Manufacturing, Inc.24M - South Carolina - School Bus Kit - Metal — Certified Safety Manufacturing, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.PILLING — TELEFLEX INCORPORATEDMerocel™ — MEDTRONIC XOMED, INC.36M - Marathon Petroleum LS Terminals - Metal — Certified Safety Manufacturing, Inc.24M - Enbridge - Metal — Certified Safety Manufacturing, Inc.24PW - Verizon — Certified Safety Manufacturing, Inc.10M - Premium - Metal Red — Certified Safety Manufacturing, Inc.Merocel™ — MEDTRONIC XOMED, INC.36M - City of Gastonia - Metal — Certified Safety Manufacturing, 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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