PlainRecalls

Helena Laboratories, Corp.

Compiled from official public sources by the publisher.

11 recalls on record · Latest: Jun 28, 2023

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Agency notice ledger

Federal filing book Helena Laboratories, Corp. LIGHT-BOOK · SINGLE-AGENCY

#1,352 of 14,151 · 11 notices · 0.011% archive

  • BOOK 11 notices
  • RANK #1,352 of 14,151
  • SHARE 0.011% archive
  • AGENCY FDA Devices (11)
  • CAT medical devices
  • CATS 1 category
  • LATEST Jun 28, 2023
  • PHOTO Agfa Corp.

Nearest notice-volume peer: Agfa Corp. (0 notice gap)

Helena Laboratories, Corp. accounts for about 0.011% of the 104,423-notice archive on 11 distinct filings — a mid share signal beside absolute volume. FDA · CPSC · USDA FSIS · NHTSA notice stamps for this firm. Read with this firm → · Dominant category → · Similar-volume firm →

How Helena Laboratories, Corp. compares to 14,151 recalling firms

Helena Laboratories, Corp. ranks 1,352nd of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Helena Laboratories, Corp. vs all firms by recall-notice count

Where this firm's archive sits among every tracked recalling manufacturer

11 1352nd of 14151 higher than 12,735 of 14,151 firms

Firms, banded by distinct federal recall-event inventory

Each bar is a band; taller bars hold more firms. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source FDA · CPSC · USDA FSIS · NHTSA federal recall filings · 2026-09-15

Helena Laboratories, Corp. in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Helena Laboratories, Corp. holds about 0.011% of archive notices alongside 11 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Jun 28, 2023

Serrated Blade Applicator Kit (12 Sample), REF: 552687, For use with the Spife Nexus system, Contents: 30 Blade Applicators. used in invitro diagnostics
FDA Devices Moderate Jun 15, 2022

V8 Immunodisplacement Kit REF 1803
FDA Devices Moderate Feb 17, 2021

Cascade Abrazo aPTT Test Card - Product Usage: are to be used with the Cascade Abrazo analyzer and are intended for the determination of the activated Partial Thromboplastin Time (aPTT) of citrated whole blood or plasma, Model 5722, For Export Only.
FDA Devices Moderate Dec 23, 2020

K-ACT Actalyke Clotting Test Tubes that are used in the: ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, and ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM.
FDA Devices Low Dec 4, 2019

Platelet Aggregation Kit, Cat. No.5369, For use in platelet aggregation studies, Contains: 2X1 mL ADP Reagent containing adenosine diphosphate, 2X 1 mL Collagen Reagent containing collagen (equine tendon), 2 x 1 mL Epinephrine Reagent containing L-epinephrine, FOR IN-VITRO DIAGNOSTIC USE, Store at 2 to 8 C, 0011724/14(3)
FDA Devices Low Dec 4, 2019

Collagen Reagent, Cat. No. 5368, 2 X 1 mL, For use in platelet aggregation studies, Contains: Collagen (equine tendon) For In-Vitro Diagnostic Use,
FDA Devices Low Nov 13, 2019

SPIFE Alkaline Hemoglobin Kit, Cat. No. 3415, for use in the separation and quantitation of hemoglobins by agarose electrophoresis using the SPIFE systems
FDA Devices Moderate Oct 16, 2019

SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Devices Moderate Oct 9, 2019

Cascade Abrazo aPTT Test Card, Model 5722, For Export Only. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Devices Moderate Jul 17, 2019

ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.
FDA Devices Moderate Jul 17, 2019

ColoCARE, Cat. No. 5650, packaged 250 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX.

Helena Laboratories, Corp. holds a measurable archive slice

Drug and device firms outside this manufacturer and state, matched by notice volume and category footprint.

Similar recall count

Nearest multi-notice firms by distinct-event totals (11 here — thin-book).

Agfa Corp. 11 Ajinomoto Foods North America Inc. 11 Akron Pharma, Inc. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11

Similar medical devices volume

Nearest multi-notice firms in the same narrow category lane.

Agfa Corp. 11 Amendia, Inc 11 Aniara Diagnostica LLC 11 Arjohuntleigh Polska Sp. z.o.o. 11

Frequently Asked Questions

How many federal recall notices name Helena Laboratories, Corp.? ▼
PlainRecalls indexes 11 distinct federal recall events naming Helena Laboratories, Corp., aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (archive as of September 2026). That count is an issuance inventory, not a hazard score.
Where does Helena Laboratories, Corp. sit among other recalling firms? ▼
Helena Laboratories, Corp. ranks #1,352 of 14,151 by distinct recall-event count among 14,151 firms in this archive (90th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Helena Laboratories, Corp.'s notices? ▼
FDA Devices accounts for 11 of this firm's 11 indexed notices.
What product category dominates Helena Laboratories, Corp.'s filing book? ▼
Filings for Helena Laboratories, Corp. span 1 product category, led by medical devices. Browse that category archive for peer firms and related notices.
Is a higher notice count more dangerous? ▼
No. Archive size reflects how often federal agencies publish recalls naming the firm — reporting volume, coverage, and product range all move the number. Always verify the individual notice with the issuing agency before acting on a specific product.
Helena Laboratories, Corp.: 11 federal recall notices aggregated from FDA, CPSC, USDA FSIS, and NHTSA filings (lead agency FDA Devices). Verify individual notices with FDA directly before acting on a specific recall.

Firm-level totals aggregate distinct federal recall events naming Helena Laboratories, Corp.; individual notices remain authoritative on each linked recall page.

Methodology · Corrections · FDA · CPSC · USDA FSIS · NHTSA · Archive as of September 2026