Microbiologics Inc: Medical Device Recall in 2022 - (Recall #: Z-0636-2022)

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:

KWIK-STIK(TM) labeled as containing Actinomyces odontolyticus. Each KWIK-STIK" unit contains a lyophilized pellet of a single microorganism strain, a reservoir of hydrating fluid and an inoculating swab. Each device is sealed within a laminated pouch that contains a desiccant to prevent adverse moisture accumulation. A KWIK-STIK" catalog number ending in P is a duopak and contains two KWIKSTIK" sticks.

Product Classification:

Class III

Date Initiated: March 2, 2017

Date Posted: February 16, 2022

Recall Number: Z-0636-2022

Event ID: 89412

Reason for Recall:

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

Status: Terminated

Product Quantity: 2 units

Code Information:

Catalog Number: 0939P, Lot Number: 939-47-2, UDI: 20845357022701

Distribution Pattern:

International distribution in the countries of Canada and Germany.

Voluntary or Mandated:

Voluntary: Firm initiated