Home › Device types › FQM
Bandage, Elastic
FDA product code FQM · Class 1 · General Hospital
2,317
Registered devices
329
Adverse events
30
Recalls
42
510(k) clearances
Devices with this code
DeRoyal — DEROYAL INDUSTRIES, INC.3" DLX ELASTIC BANDAGE W/HOOK 5YD — Bird & Cronin, LLCTronex International, Inc. — TRONEX INTERNATIONAL, INC.N/A — Guangzhou Huiming Fibre Products Co., Ltd.Soosung Elastic Bandage — soosung medicalMUELLER TAPEWRAP PREMIUM 48 ROLLS — Mueller Sports Medicine, Inc.MEDLINE — MEDLINE INDUSTRIES, INC.MEDLINE — MEDLINE INDUSTRIES, INC.Tubifast® — Mölnlycke Health Care ABBioseal Inc. — BIOSEALBioseal Inc. — BIOSEALDeRoyal — DEROYAL INDUSTRIES, INC.Stretch Gauze Bandage Roll, Non-Sterile — Dynarex CorporationGSPCARE — Hangzhou Gspmed Medical Appliances Co., Ltd.MT Spandage — MEDI-TECH INTERNATIONAL CORPORATIONViveCare — VIVE HEALTH LLCMT Spandage — MEDI-TECH INTERNATIONAL CORPORATIONMUELLER TAPEWRAP PREMIUM 48 ROLLS — Mueller Sports Medicine, Inc.DeRoyal — DEROYAL INDUSTRIES, INC.Co-Ease — Hemasource, Inc.Tronex International, Inc. — TRONEX INTERNATIONAL, INC.HCS — DYAD MEDICAL SOURCING, LLCZD — Zhende Medical Co., Ltd.Custom Healthcare Systems Inc. — Manus Medical, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-02-27 | Medline Industries, LP | Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. |
| 2025-03-03 | MEDLINE INDUSTRIES, LP - Northfield | There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits. |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have bee |
| 2024-04-02 | Andover Healthcare Inc. | A packaging seal gap could impact the sterility of the product. |
| 2022-06-22 | ASO LLC | The product falls apart during handling after removal from its primary packaging. |
| 2022-05-25 | Mckesson Medical-Surgical Inc. Corporate Office | Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lot |
| 2022-02-01 | BSN Medical Inc | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. |
| 2020-08-21 | North American Rescue LLC. | Lack of sterility assurance of the 30-0171 |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
| 2019-06-19 | Andover Healthcare Inc. | Incomplete packaging seal of sterile product |
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