Biocare Medical recalls

Biocare Medical has 10 recalls on record with the FDA and USDA, the earliest in 2015 and the latest reported on 13 Nov 2024. 1 is still ongoing. The most frequent reason is device malfunction.

Total recalls10since 2015

Last 12 months0reported

Class I00% of total

Ongoing1latest 13 Nov 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 1 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 8 80%Class III 2 20%

Why biocare medical is recalled

Product types

By year

2024110%
2021110%
2020110%
2018220%
2016110%
2015440%

Ongoing biocare medical recalls

1 active

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	intelliPATH Universal HRP Detection Kit recalled by Biocare Medical	Biocare Medical	Lead & Heavy Metals	Nationwide

All biocare medical recalls, newest first

10 total

Reported	Class	Recall	Company	Reason	Where
13 Nov 2024Device	CLASS II	intelliPATH Universal HRP Detection Kit recalled by Biocare Medical	Biocare Medical	Lead & Heavy Metals	Nationwide
7 Apr 2021Device	CLASS II	IntelliPath FLX, Automated Staining Instrument recalled	Biocare Medical	Device Malfunction	15 states
17 Jun 2020Device	CLASS II	4plus Streptavidin HRP Label recalled by Biocare Medical	Biocare Medical	Other	5 states
26 Sep 2018Device	CLASS II	URO-3 Triple Stain (CD44 + p53) with CK20 recalled by Biocare Medical	Biocare Medical	Labeling Errors	Nationwide
11 Jul 2018Device	CLASS II	Vulcan Fast Red Chromogen Kit recalled by Biocare Medical	Biocare Medical	Potency & Assay	12 states
27 Apr 2016Device	CLASS III	Mach 4 Mouse Probe vial within the Mach 4 Universal HRP-Polymer Kit recalled	Biocare Medical	Labeling Errors	Nationwide
18 Nov 2015Device	CLASS II	Smooth Muscle Action (SMA) Immunohistochemistry reagent recalled	Biocare Medical	Other	Nationwide
3 Jun 2015Device	CLASS III	D2-40 (Lymphatic Marker) recalled by Biocare Medical	Biocare Medical	Other	Nationwide
6 May 2015Device	CLASS II	CD99 Catalog number PM008 AA; For In Vitro Diagnostic Use. Product recalled	Biocare Medical	Device Malfunction	Nationwide
21 Jan 2015Device	CLASS II	MUM-1 (Multiple myeloma oncogene-1) recalled by Biocare Medical	Biocare Medical	Device Malfunction	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.