Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0637-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit contains six lyophilized pellets of a single microorganism strain, in a glass vial. Each vial is sealed and contains a desiccant to prevent adverse moisture accumulation. A LYFO Disk" catalog number ends in L.

Product Classification:

Class III

Date Initiated: March 2, 2017

Date Posted: February 16, 2022

Recall Number: Z-0637-2022

Event ID: 89412

Reason for Recall:

Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.

Status: Terminated

Product Quantity: 1 unit

Code Information:

Catalog Number: 0939L, Lot Number: 939-47-1, UDI: 10845357022728

Distribution Pattern:

International distribution in the countries of Canada and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated