CriterionRecalls & reported problems across all models
Henry Schein, Inc. · 2 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names at least one Criterion model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls
- 1
We found 2 models of Criterion by Henry Schein, Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Jan 14, 2026 and Jan 14, 2026 — classified as 1 injury.
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Criterion recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 21, 2023Class IIOpen, Classified
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Z-1147-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported Criterion problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Skin Discoloration1
Criterion models
2 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Criterion 5703281Mask, surgical1 recall0 reports
- Criterion 5703276Mask, surgical1 report
Recent Criterion adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryJan 14, 2026Adverse Event Without Identified Device or Use Problem
A NURSE EXPERIENCED TEMPORARY REDNESS ON THE NOSE AFTER WEARING THE MASK WITH THE BLUE SIDE FACING OUTWARD. THE NURSE HAD USED THIS MASK TYPE BEFORE INSIDE OUT WITHOUT ISSUES, REPORTED NO KNOWN ALLERGIES, NO BROKEN SKIN AND REQUIRED NO MEDICAL TREATMENT OR FOLLOW-UP.
Patient problems: Skin Discoloration
MAUDE report 24072255 ↗
Other Henry Schein, Inc. products
All Henry Schein, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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