The Recall Desk
HighFDA (Devices)·Z-1146-2024·Announced 2024-02-28

Henry Schein Criterion Level 3 Earloop Masks Recalled for Non-Validated Equipment

AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks because they were produced on non-validated equipment not included in the initial product qualification.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This FDA Class II recall addresses masks produced on non-validated equipment. Per the rubric criteria for Score 3, this qualifies as a risk-of-harm product where injury has not yet been reported, warranting a High severity classification.

Plain-English summary

AMD Medicom Inc. is recalling Henry Schein Criterion Level 3 Earloop Masks (item code 570-2448) distributed nationwide. The masks were produced on alternate production equipment that was not validated and was not included in the initial product qualification process.

Affected lot numbers are 2337, 2338, 2342, 2343, and 2344. The recall involves 720 cases distributed in Florida, Iowa, Indiana, Pennsylvania, Nevada, and Texas.

Because these masks were produced on non-validated equipment, there is concern that they may not meet their intended specifications or performance standards.

Consumers and healthcare facilities should stop using masks from the affected lot numbers and contact AMD Medicom Inc. or their distributor for information regarding replacement or return.

The recalled product

Product
HENRY SCHEIN¿ CRITERION¿ EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-2448)
Manufacturer
AMD Medicom Inc.
Category
Medical Device — Protective Equipment
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • Item Code: 570-2448
  • UDI DI: 10304040142520
  • Lot #s: 2337
  • 2338
  • 2342
  • 2343
  • 2344

Distribution

Distributed nationwide across the United States.

The notice also names 6 states specifically:

Part of a larger recall action

This product is one of 3 recalled by AMD Medicom Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · AMD Medicom Inc.

See all →