LYFO DISKRecalls & reported problems across all models
Microbiologics Inc. · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
4 open recalls name at least one LYFO DISK model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls
- 10
We found 9 models of LYFO DISK by Microbiologics Inc. in the FDA's device registry (GUDID). Together they are named in 1 adverse event report in the FDA's MAUDE database, received between Dec 26, 2025 and Dec 26, 2025 — classified as 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
10 FDA recall records name at least one of these models by its device identifier, 4 still open.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
LYFO DISK recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Dec 2, 2025Open, Classified
Affected units may fail to recover the target microorganism Campylobacter jejuni subsp. jejuni derived from ATCC 29428.
Z-0986-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 27, 2025Open, Classified
KWIK-STIK REF numbers: 0894P, 0894K and LYFO DISK" 0894L may result in failure to recover the target microorganism. All lots of REF 894-76 are impacted.
Z-2195-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Jun 17, 2025Open, Classified
Affected products contain Staphylococcus epidermidis instead of the expected Brevundimonas diminuta. This may cause the user's quality control to fail and delayed diagnosis for the patient.
Z-2124-2025 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Oct 18, 2023Open, Classified
A complaint investigation showed that the bulk pellets (lot 794-142) were contaminated with Aspergillus flavus.
Z-0308-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
- Dec 16, 2020Terminated
Contamination with S. epidermidis
Z-0511-2022 · Root cause: Material/Component Contamination · Recall details · FDA record ↗
- Oct 1, 2020Terminated
Potential contamination with Escherichia coli, Staphylococcus epidermidis and S. warneri.
Z-0583-2022 · Root cause: Unknown/Undetermined by firm · Recall details · FDA record ↗
- Feb 18, 2020Terminated
Tests returning incorrect susceptible results. High Level Gentamicin Synergy value was out of specification (sensitive) when analyzed on the Vitek 2 AST-GP67 card, and these lots failed the disk diffusion method used for product release.
Z-0586-2022 · Root cause: Process design · Recall details · FDA record ↗
- Mar 2, 2017Terminated
Potential for product labeled as Actinomyces odontolyticus is actually Eggerthella lenta.
Z-0637-2022 · Root cause: Labeling False and Misleading · Recall details · FDA record ↗
- Jul 17, 2015Completed
LYFO Disk Catalog #0983L is to contain Candida tropicalis. However, lot number 983-40-3 under Catalog #0983L, labeled as Candida tropicalis, is actually Yersinia entercolitica. This labeling error may cause a user's quality control to fail, resulting in testing needing to be repeated and delayed test results.
Z-0788-2022 · Root cause: Labeling mix-ups · Recall details · FDA record ↗
- Oct 6, 2014Terminated
This strain should be resistant to high levels of Gentamicin and be resistant to Gentamicin Synergy. A specific lot was found susceptible to Gentamicin Synergy during in-house testing.
Z-0713-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗
Most reported LYFO DISK problems
Device problems
- Fluid/Blood Leak1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
LYFO DISK models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- LYFO DISK™ 0947LKIT, QUALITY CONTROL FOR CULTURE MEDIA2 recalls0 reports
- LYFO DISK™ 0959LKIT, QUALITY CONTROL FOR CULTURE MEDIA2 recalls0 reports
- LYFO DISK™ 0325LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0794LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0805LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0894LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0939LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0983LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 recall0 reports
- LYFO DISK™ 0303LKIT, QUALITY CONTROL FOR CULTURE MEDIA1 report
Recent LYFO DISK adverse event reports
The 1 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2025Fluid/Blood Leak; Fluid/Blood Leak
IT WAS REPORTED THAT A PATIENT EXPERIENCED A DENTAL IMPLANT FRACTURE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23895668 ↗
Other Microbiologics Inc. products
All Microbiologics Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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