Home › Device types › FXX
Mask, Surgical
FDA product code FXX · Class 2 · General, Plastic Surgery
2,280
Registered devices
569
Adverse events
12
Recalls
607
510(k) clearances
Devices with this code
MEDICOM ASSUREMASK VALIANT — AMD Medicom Incmaxill Plus Earloop Style Procedural Masks, Classic, Lavender — MAXILL, INC.Meijer — MEIJER, INC.RTMED — Shandong Haidike Medical Products Co., Ltd.Halyard — O&M HALYARD, INC.Precept® — PRECEPT MEDICAL PRODUCTS, INC.PRIMED — priMED Medical Products IncIsofluidTM Earloop Mask — CROSSTEX INTERNATIONAL, INC.AOK — AOK TOOLING LIMITEDPRIMED — priMED Medical Products IncTUTEM — Alpha Pro Tech, Inc.Midway Select — MIDWAY DENTAL SUPPLY, LLCMedline — MEDLINE INDUSTRIES, INC.McKesson — MCKESSON MEDICAL-SURGICAL INC.Natural Extensions — BENCO DENTAL SUPPLY CO.CONVERTORS — Cardinal Health 200, LLCLuesay — Guangdong Golden Leaves Technology Development Co., Ltd.MEDLINE — MEDLINE INDUSTRIES, INC.Medline — MEDLINE INDUSTRIES, INC.Precept® — PRECEPT MEDICAL PRODUCTS, INC.VIVIT Supply — Vivit Supply LLCPRIMED — priMED Medical Products IncHalyard — O&M HALYARD, INC.CONVERTORS — Cardinal Health 200, LLC
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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