Biocare Medical, LLC recalls
Every recall we track for Biocare Medical, LLC — 5 in all, from 2018–2024 — plus the complaints and injury reports the public filed about them.
Recalls per year, by danger level
5 recalls since 2017.
All FDA recall records for Biocare Medical, LLC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 2 | 0 | 2 |
| 2019 | 0 | 0 | 1 | 0 | 1 |
| 2020 | 0 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 1 | 0 | 0 | 1 |
| 2022 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 0 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 1 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 0 | 0 | 0 |
What to do if you have a recalled Biocare Medical, LLC product
- Match the model, catalog or lot number on your device to the recall.
- Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals.
- Report problems to FDA MedWatch.
All Biocare Medical, LLC recalls
5 shown- Lower riskMedical device
Biocare Medical, LLC recalls intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE
Biocare Medical recalls intelliPATH Universal HRP Detection Kits with DAB buffer that may cause weak or no staining, leading to test failures. Affected kits include specific model numbers and lot codes.
Biocare MedicalSep 25, 2024 - Use cautionMedical device
Biocare Medical, LLC recalls BIOCARE Medical , IntelliPath FLX, Automated Staining Instrument, Ref: " Model Number:IPS0001US and IPS0001INTL
Biocare Medical recalls IntelliPath FLX automated staining instruments with software version 3.5.3.1 due to potential unintended movement that could cause damage or liquid spills. Affected units include specific US and OUS serial numbers.
Biocare MedicalFeb 25, 2021 - Lower riskMedical device
Biocare Medical, LLC recalls 4plus Streptavidin HRP Label, Conjugated Streptavidin Horseradish Peroxidase, Detection Component, Catalog Number:
Biocare Medical recalls 4plus Streptavidin HRP Label (HP604H) due to potential invalid test results. This may cause patient tissue consumption and delayed diagnosis. Affected units have specific lot numbers.
Biocare MedicalOct 10, 2019 - Lower riskMedical device
Biocare Medical, LLC recalls Vulcan Fast Red Chromogen Kit 2, part of an immunohistochemistry (IHC) procedure using an alkaline phosphatase (AP)
Biocare Medical recalls Vulcan Fast Red Chromogen Kit 2 (FR805-5L, FR805S) due to stability issues with raw materials causing chromogen failure in IHC procedures.
Biocare MedicalApr 24, 2018 - Lower riskMedical device
Biocare Medical, LLC recalls URO-3 Triple Stain (CD44 + p53) with CK20, Catalog #: PM370TSAA, Package Type: Bag, which contains components: a) CD44
Biocare Medical recalls URO-3 Triple Stain (CD44 + p53) with CK20 kits due to incorrect staining patterns from mislabeled components. Affected kits may lead to inaccurate cancer diagnosis results.
Biocare MedicalMar 15, 2018
Biocare Medical, LLC recall questions
How many recalls has Biocare Medical, LLC had?
5 recalls from Biocare Medical, LLC are on record with U.S. safety agencies, from 2018–2024.
What is the most recent Biocare Medical, LLC recall?
Biocare Medical, LLC recalls intelliPATH Universal HRP Detection Kit, REF: IPK5011G80, containing DAB Buffer, Catalog Number: IPBF5009G20; ONCORE, dated Sep 25, 2024. Every Biocare Medical, LLC recall is listed on this page, newest first.
What should I do if I have a recalled Biocare Medical, LLC product?
Match the model, catalog or lot number on your device to the recall. Ask the prescribing clinician or supplier what to do — many device recalls are corrections, not removals. Report problems to FDA MedWatch.
How do I get alerts for new Biocare Medical, LLC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.