PlainRecalls

Biocare Medical, LLC

Compiled from official public sources by the publisher.

10 recalls on record · Latest: Nov 13, 2024

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Agency notice ledger

Federal filing book Biocare Medical, LLC LIGHT-BOOK · SINGLE-AGENCY

#1,431 of 14,151 · 10 notices · 0.010% archive

  • BOOK 10 notices
  • RANK #1,431 of 14,151
  • SHARE 0.010% archive
  • AGENCY FDA Devices (10)
  • CAT medical devices
  • CATS 1 category
  • LATEST Nov 13, 2024
  • PHOTO 4e Brands North Ameri…

Nearest notice-volume peer: 4e Brands North America, Llc (0 notice gap)

Biocare Medical, LLC accounts for about 0.010% of the 104,423-notice archive on 10 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 →

Where Biocare Medical, LLC sits among 14,151 recalling firms

Biocare Medical, LLC ranks 1,431st of 14,151 tracked firms by distinct recall-event count. Archive size reflects filing volume, not inherent product danger.

Biocare Medical, LLC vs all firms by recall-notice count

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

10 1431st of 14151 higher than 12,602 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 · 2026-09-13

Biocare Medical, LLC in the notice-volume neighbourhood

Distinct federal recall events among this firm and nearest nationwide peers

notices

What this shows Biocare Medical, LLC holds about 0.010% of archive notices alongside 10 distinct filings.

Source FDA · CPSC · USDA FSIS · NHTSA filings aggregated by PlainRecalls As of September 2026
FDA Devices Moderate Nov 13, 2024

intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE Pro DAB Chromogen, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60; IP DAB Chromogen Kit 80 ml, REF: IPK5010G80, containing DAB Buffer, Catalog Number: IPBF5009G20; DAB kit, REF: OPRI6056KT180, containing DAB Buffer, Catalog Number: OPRI6055T60 Folate Receptor alpha IHC Assay Kit, REF: IPI4006KG10, containing DAB Buffer, Catalog Number: IPBF5009G20
FDA Devices Moderate Apr 7, 2021

BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL containing software version 3.5.3.1
FDA Devices Moderate Jun 17, 2020

4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number: HP604H
FDA Devices Moderate Sep 26, 2018

URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44 + p53, Catalog #: PM373DSAA, Package Type: Bottle, and b) CK20, Catalog #: PM062AA, Package Type: Bottle Product Usage: URO-3 Triple Stain (CD44 + p53) with CK20 is a cocktail of mouse monoclonal and rabbit monoclonal antibodies that is intended for laboratory use in the qualitative identification of CD44, p53 and CK20 proteins by immunohistochemistry (IHC) in formalin-fixed
FDA Devices Moderate Jul 11, 2018

Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP) detection system. Catalog numbers FR805-5L and FR805S
FDA Devices Low Apr 27, 2016

Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit; Catalog number M4U534L; For In Vitro Use Immunology: MACH 4 Universal HRP-Polymer is a horseradish peroxidase (HRP)-antibody conjugate system intended for use in the detection of mouse lgG and lgM, and rabbit IgG primary antibodies on formalin-fixed, paraffin-embedded (FFPE) tissues in an immunohistochemistry (IHC) procedure. The clinical interpretation of any staining or its absence should be complemented by morphological
FDA Devices Moderate Nov 18, 2015

Smooth Muscle Action (SMA) Immunohistochemistry reagent. Catalog numbers: CME305A-0.1ml; CME305B - 0.5 ml, PME305AA - 6.0 ml prediluted and ready to use. They are the same product with the same intended use. Chemistry - IVD Smooth Muscle Actin (SMA) antibody recognizes the alpha-smooth muscle isoform of actin. This antibody recognizes the alpha-smooth muscle isoform of actin. This MAb is reportedly useful for identifying tumors arising from smooth muscle and myoepithelial cells.
FDA Devices Low Jun 3, 2015

D2-40 (Lymphatic Marker); For In Vitro Diagnostic; Catalog number: PM266AA Product Usage: In Vitro Diagnostic Use.: a mouse monoclonal antibody that is intended for laboratory use in the qualitative identification of O-linked sialoglyprotein protein by immunohistochemistry (ICH) in formalin fixed paraffin embedded human tissues.
FDA Devices Moderate May 6, 2015

CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product Usage: Provides adjunctive diagnostic information following the primary diagnosis of a neoplasm by conventional histopathology methods.
FDA Devices Moderate Jan 21, 2015

MUM-1 (Multiple myeloma oncogene-1), catalog number PRM352 AA; Product Usage: For In Vitro Diagnostic Use. This antibody may be used as a tool for the identification and the sub classification of lymphoid malignancies : Multiple myeloma oncogene-1 (MUM-1) is a protein encoded by MUM-1 gene. MUM-1 protein is expressed in the nuclei and cytoplasm of plasma cells and a small percentage of germinal center (GC) B-cells located in the light zone. MUM-1 [BC5] labels MUM-1protein in centrocytes

Biocare Medical, LLC holds a measurable archive slice

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

Similar medical devices volume

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

Amerx Health Care Corp. 10 Bausch & Lomb Surgical, Inc. 10 Beekley Corporation 10 Cypress Medical Products LLC 10

Frequently Asked Questions

How many federal recall notices name Biocare Medical, LLC? ▼
PlainRecalls indexes 10 distinct federal recall events naming Biocare Medical, LLC, 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 Biocare Medical, LLC sit among other recalling firms? ▼
Biocare Medical, LLC ranks #1,431 of 14,151 by distinct recall-event count among 14,151 firms in this archive (89th percentile of firms with fewer notices). Rank tracks filing frequency, not product danger.
Which agency issues most of Biocare Medical, LLC's notices? ▼
FDA Devices accounts for 10 of this firm's 10 indexed notices.
What product category dominates Biocare Medical, LLC's filing book? ▼
Filings for Biocare Medical, LLC 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.
Biocare Medical, LLC: 10 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 Biocare Medical, LLC; individual notices remain authoritative on each linked recall page.

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