The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1147-2024·Announced 2024-02-28

Henry Schein Criterion Anti-Fog Earloop Masks Recalled for Equipment Validation Issue

AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue) because the masks were produced on non-validated equipment not included in the product qualification process.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall of medical protective equipment where the manufacturing process was not validated according to product qualification standards. No illnesses or injuries have been reported, but manufacturing controls are critical for ensuring the safety and performance of protective equipment.

Plain-English summary

AMD Medicom Inc. is recalling Henry Schein Criterion Anti-Fog Earloop Masks Level 3 (Blue), item code 570-3281. The recall affects 960 cases (containing 10 boxes per case and 50 masks per box) distributed nationwide in Florida, Iowa, Indiana, Pennsylvania, Nevada, and Texas.

The masks were manufactured on alternate production equipment that was not included as part of the initial product qualification process. This represents a manufacturing control issue that may affect product quality and performance.

Consumers who have purchased these masks should discontinue use and contact their supplier or AMD Medicom Inc. for instructions on how to obtain replacement products. The recalled lot numbers are 2340, 2341, and 2342, and the UDI Device Identifier is 10304040168629.

The recalled product

Product
HENRY SCHEIN¿ CRITERION¿ ANTI-FOG EARLOOP MASKS LEVEL 3 (BLUE) (item code 570-3281)
Manufacturer
AMD Medicom Inc.
Category
Medical Device — Personal 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 (5)

  • Item Code: 570-3281
  • UDI DI: 10304040168629
  • Lot #s: 2340
  • 2341
  • 2342

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 →

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