Severity
Low
LowClass IIITerminated
FDA Devices recall · Reported February 16, 2022
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.
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Microbiologics Inc recalled LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit … - a low-severity action.
LYSO Disk(TM) labeled as containing Actinomyces odontolyticus. Each LYSO Disk" unit … was recalled by Microbiologics Inc in February 16, 2022. Reason: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.. Check the official notice for the remedy. Verify recall #Z-0637-2022 with the FDA Devices before acting.
The recall
Microbiologics Inc issued this low-severity FDA Devices recall-Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta..
- Low
- severity level
- 1 units
- affected scope
- Class III
- classification
- February 16, 2022
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0637-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0637-2022) was formally reported on February 16, 2022, with the manufacturer initiating the action on March 2, 2017. It is classified under Low severity (Class III), with a current status of Terminated. Microbiologics Inc is listed as the recalling firm, operating out of Saint Cloud, MN. Federal records list the affected scope as 1 unit.
The documented reason for this recall is: Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta. Distribution data in the federal record shows the product reached: International distribution in the countries of Canada and Germany.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
1 unit
Related Recalls
6
3 from same agency
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.
Reason for recall
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | Z-0637-2022 |
| Date reported | February 16, 2022 |
| Date initiated | March 2, 2017 |
| Recalling firm | Microbiologics Inc |
| Firm location | Saint Cloud, MN |
| Affected scope | 1 unit |
| Distribution | International distribution in the countries of Canada and Germany. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0637-2022) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Microbiologics Inc. Units affected: 1 unit.
Why was this product recalled? ▼
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 16, 2022. Severity: Low. Recall number: Z-0637-2022.
Where was the recalled product distributed? ▼
Distribution: International distribution in the countries of Canada and Germany..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0637-2022) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 16, 2022. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.