Home › Device types › FQM
Bandage, Elastic
FDA product code FQM · Class 1 · General Hospital
2,258
Registered devices
297
Adverse events
30
Recalls
42
510(k) clearances
Devices with this code
MT Spandage — MEDI-TECH INTERNATIONAL CORPORATIONSHUR-BAND ST 6X5 10/CS — HARTMANN USA, INC.Tubigrip® — Mölnlycke Health Care AB5904 Bandage Kit — SIGVARIS INCSensi-Wrap, Self Adherent — Dynarex CorporationSurgilast® — Derma Sciences Canada IncHCS — DYAD MEDICAL SOURCING, LLCMT Spandage — MEDI-TECH INTERNATIONAL CORPORATIONBioseal Inc. — BIOSEALSURGYCO — Surgyco LLCCVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDGSPCARE — Hangzhou Gspmed Medical Appliances Co., Ltd.FLEXIGRIP TUBULAR BNDG SIZE C — Bird & Cronin, LLCCotZee — Hemasource, Inc.AMD-RITMED — AMD Medicom IncHenry Schein — HENRY SCHEIN, INC.Sensi-Wrap, Self Adherent — Dynarex CorporationRhino Rescue — Anji Hengfeng Sanitary Material Co., LtdRTMED — Shandong Haidike Medical Products Co., Ltd.n.a. — VBM Medizintechnik GmbHDeRoyal — DEROYAL INDUSTRIES, INC.Bioseal Inc. — BIOSEALASP MEDICAL — Asp Global, LLCBioseal Inc. — BIOSEAL
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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