PlainRecalls

Biomerieux Inc

Compiled from official public sources by the editorial team.

421 recalls on record · Latest: Feb 11, 2026

Biomerieux Inc Recall Insight

Biomerieux Inc appears on 421 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.414% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Feb 11, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.

On this page of 21 entries, severity tagging shows 0 critical, 21 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 21 of 21 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (21). The date window on this page runs from Oct 17, 2012 to Nov 28, 2012.

Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Combo Module, catalog number 247014, Industrial instrument The product is most commonly used to isolate and recover specimen…

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Control Module, catalog number 210148, Industrial instrument The product is most commonly used to isolate and recover specim…

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Combo Module, catalog number 200291, Industrial instrument The product is most commonly used to isolate and recover specimen…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 412002 …

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, USB Instrument & Update, 3D B.40 USB-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412559 …

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D IND USB-ML02, Industry instrument software update, German, French, catalog number 412003 Software up…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML03, Clinical instrument software, Danish, Greek, Polish, Portuguese, catalog number 412623 Sof…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D I ZIP-ML01, Industry instrument software update, English, Spanish, Italian, catalog number 413483 So…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, USB HDW, BTA3D CONTROL-B-B.40, Clinical instrument software, USB update and mounting hardware-English, catalog number 411958 Softw…

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Control Module, catalog number 210147, Clinical instrument The product is most commonly used to isolate and recover specimen…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 ZIP-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, ca…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 BTA3D-ZH01, Clinical instrument software, Chinese, catalog number 411816 Software update for the cli…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML06, Clinical instrument software, Japanese, Korean, Norwegian, Brazilian, Portuguese, Turkish, cat…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, B.40, 3D I USB-ML02, Industry instrument software update, German, French, catalog number 413482 Software upda…

FDA Devices Moderate Nov 28, 2012

0.9% Sodium Chloride Injections, USP, 1000ml, VWR/Baxter Product Usage: The concentrated sodium chloride is used to prepare inoculum that is anal…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML04, Clinical instrument software, Czech, Estonian, Hungarian, Romanian, catalog number 412620 S…

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT 3D 60, catalog number, 248009, Clinical instrument The product is most commonly used to isolate and recover specimens drawn …

FDA Devices Moderate Nov 28, 2012

bioMerieux BacT/ALERT Combo Module, catalog number, 200290, Clinical instrument The product is most commonly used to isolate and recover specimens…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D B.40 USB-ML02, Clinical instrument software, German, French, Swedish, catalog number 411925 Software upda…

FDA Devices Moderate Nov 28, 2012

bioMerieux Kit, Instrument & Update, 3D IND ZIP-ML 01, Industry instrument software update, English, Spanish, Italian, catalog number 412005 Softw…

FDA Devices Moderate Oct 17, 2012

PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured…

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Data Sources

  • Source: FDA + CPSC + NHTSA - federal recall filings naming this firm. Verify with FDA, CPSC, or NHTSA directly.
  • Source: PlainRecalls Manufacturer Index - firm-level aggregation across all three federal recall feeds

Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.