Maxima 5702047Recalls & reported problems
Henry Schein, Inc. · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10304040138912), received between Oct 6, 2023 and Oct 6, 2023 — classified as 1 injury.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Asthma1
- Itching Sensation1
- Rash1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
A 40 YEAR OLD FEMALE DENTIST HAD A MILD SKIN IRRITATION AND RASH ON HER FACE AFTER WEARING THE MASKS AS WELL AS HAVE AN ASTHMA ATTACK. THE DURATION OF THE SYMPTOMS WERE FOR TWO DAYS UNITL SHE NOTICED THE CORRELATION TO THE MASKS. SHE NEEDED TO TAKE ABUTEROL TO HELP AND HAS SINCE GOTTEN BETTER.
Patient problems: Asthma; Itching Sensation; Rash
MAUDE report 17890350 ↗
Other Mask, surgical devices
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- Halyard 47147O&M Halyard, Inc. · Mask, surgical1 recall1 report
- Halyard 47500O&M Halyard, Inc. · Mask, surgical1 recall0 reports
- Henry Schein 5702448Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Criterion 5703281Henry Schein, Inc. · Mask, surgical1 recall0 reports
- Medline NON27410Medline Industries, Inc. · Mask, surgical14 reports
- UltraTM Earloop Mask GCFCXSCrosstex International, Inc. · Mask, surgical8 reports
- CONVERTORS AT70021Cardinal Health 200, LLC · Mask, surgical5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.