Home › Device types › FXX
Mask, Surgical
FDA product code FXX · Class 2 · General, Plastic Surgery
2,179
Registered devices
534
Adverse events
12
Recalls
607
510(k) clearances
Devices with this code
Henry Schein — HENRY SCHEIN, INC.MEDICOM SAFEMASK SOFSKIN — AMD Medicom IncMeijer — MEIJER, INC.Medichoice — OWENS & MINOR DISTRIBUTION, INC.Henry Schein — HENRY SCHEIN, INC.Barrier — Mölnlycke Health Care ABMonoart — EURONDA SPADefender Safety Procedure Mask Level 3 — Defender Safety Inc.Strong Manufacturers — Strong Medical Partners LLCPRIMED — priMED Medical Products IncZhengKang — Guangzhou Zhengkang Medical Equipment Co., Ltd.5R MED — 5R MED Instruments (CHENGDU) Co., LtdPlasdent DuralProof Earloop Mask — PLASDENT CORPORATIONTHE SEA — Mexpo International Inc.BRAVAL — PATTERSON DENTAL SUPPLY, INC.CURAD — MEDLINE INDUSTRIES, INC.Henry Schein — HENRY SCHEIN, INC.VIVIT Supply — Vivit Supply LLCPRIMED — priMED Medical Products IncProGear — PRESTIGE AMERITECH, LTD.AmerisourceBergen — BP PHARMACEUTICALS LABORATORIES UNLIMITED COMPANYHenry Schein — HENRY SCHEIN, INC.Topco — Topco Associates, LLCWXD Surgical Face Mask ( Non-Sterile) — Wanxinda (Guangzhou)Technology Product Co.,Ltd.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this |
| 2024-11-08 | O&M HALYARD, INC. | Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-12-21 | AMD Medicom Inc. | Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products. |
| 2023-01-03 | Owens & Minor Distribution, Inc. | Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing |
| 2019-10-11 | AMD Medicom Inc. | Due to an error on the packaging line, some level 2 masks may have been packed in some level 3 mask boxes. The two masks are visually indistinguishable, causing |
| 2013-05-15 | Maytex Corp | Recent Lab testing conducted in March 2013 indicates that the product does not meet the standard of "Differential Pressure of only 1.6 Delta P (mm H2O/cm2)" as |
| 2003-06-03 | Safco Dental Supply Co. Inc. | The product labeling incorrectly lists the particle filtration efficiency as exceeding 99% at 0.1 micron when it should state 95% filtration. |
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