CLASS II ONGOING Device recall · Reported 28 Feb 2024 · FDA Enforcement Report
Henry Schein¿ Criterion¿ Anti-fog Earloop Masks Level 3 (blue) recalled
AMD Medicom is recalling Henry Schein¿ Criterion¿ Anti-fog Earloop Masks Level 3 (blue) (, distributed nationwide in the US. The recall was initiated on 21 Dec 2023 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1147-2024
- FDA event ID
- 93818
- Recalling firm
- AMD Medicom, Montreal, N/A
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Dec 2023
- FDA classified
- 16 Feb 2024
- Reported
- 28 Feb 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Masks, Gloves & PPE
Timeline
| 21 Dec 2023 | Recall initiated by company | |
| 16 Feb 2024 | Classified by FDA | +57 days |
| 28 Feb 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Product as listed by the FDA
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Where it was distributed
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
Questions about this recall
Why was it recalled?
Level 3 masks were produced on alternate non-validated production equipment that were not included as part of the initial qualification of the products.
Which lots are affected?
Item Code: 570-3281; UDI DI: 10304040168629; Lot #s: 2340, 2341, 2342;
Where was it sold?
US Nationwide distribution in the states of FL, IA, IN, PA, NV, TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93818This product is part of a recall event; the main page for the event is Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) recalled | AMD Medicom | Other | Nationwide | |
| CLASS II | Henry Schein¿ Criterion¿ Earloop Masks Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
More recalls from AMD Medicom
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Ritmed Neurological Sponges, Sterile recalled by AMD Medicom | AMD Medicom | Device Malfunction | 9 states |
| Device | CLASS II | Ritmed Neurological Sponges, Description recalled by AMD Medicom | AMD Medicom | Device Malfunction | 9 states |
| Device | CLASS II | Henry Schein¿ Criterion¿ Earloop Masks Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
| Device | CLASS II | Patterson¿ Procedure Earloop Masks- Anti-fog, Astm Level 3 (blue) recalled | AMD Medicom | Other | Nationwide |
| Device | CLASS II | Medicom Safemask Premier Plus Astm Level 3 Masks recalled by AMD Medicom | AMD Medicom | Packaging Defects | 13 states |
Other Masks, Gloves & PPE recalls
All 447| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | P28 Phanton Intramedullary Nail System recalled by Paragon 28 | Paragon 28 | Sterility | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Adapter for Head Positioning recalled by Baxter Healthcare | Baxter Healthcare | Other | Nationwide |
| Device | CLASS II | Cyberknife Treatment Deliver System equipped recalled | Accuray | Device Malfunction | Nationwide |
| Device | CLASS II | Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference recalled | O&M Halyard | Other | Nationwide |