Fresh Recalls

FDAClass II · Medical device · Recall Z-1984-2026 · Recalled May 6, 2026

Immy recall — Immuno-Mycologics, Inc

Agency report date: May 6, 2026.

1. Compare your item

This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.

Product named
Immy
Company / brand
Immuno-Mycologics
Lot / serial / date codes
Lot: F5061154/UDI: 00816387021091
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
Agency product description and boundaries

Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis

Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.

If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.

2. Agency hazard and consumer action

FDA reports: Neutralization Buffer may contain contaminants

No consumer remedy instructions are supplied in this record. Check the official notice and listed company contact for the agency’s current instructions.

Class II: may cause temporary or medically reversible health consequences.

Affected product: Immy recall status

3. Open the official notice or contact

Official recall ID
Z-1984-2026
Brand
All Immuno-Mycologics recalls
Classification
Class II
Units affected
101 units
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Affected products

Companies & origin

Recalling firm location
Norman, OK, United States
Firm address
2701 Corporate Centre Dr, 73069-2901

Identifying details (verbatim from the notice)

Product codes / lots
Lot: F5061154/UDI: 00816387021091
Distribution
US Nationwide distribution in the states of AZ, MS, SC, CT, NC, TX, IN, WA, MO, MI, CA.
FDA event ID
98702
Recall initiated
March 26, 2026
FDA classified
April 29, 2026
FDA report date
May 6, 2026

Other medical device recalls from around the same time

Verify with the official sources:

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Source: U.S. Food & Drug Administration. Agency excerpts come from the public data feed and may omit tables or later changes; the linked government source is authoritative. Source last checked October 22, 2026 at 6:00 PM UTC. Record retrieved August 4, 2026 at 11:00 PM UTC.

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