BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51
Summary
The FDA issued a Class II for BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC by BioPro, Inc.. Reason: Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk o.
Details
Source
Device Recall
External ID
Z-0152-2026
Action Date
2025-10-22
Status
Ongoing
Category
device
Product Description
BioPro Endo Head (Ceramic) Product ID/Description 13006 ENDO MODULAR CERAMIC SH 38 13012 ENDO MODULAR CERAMIC SH 51 13013 ENDO MODULAR CERAMIC MD 38 13019 ENDO MODULAR CERAMIC MD 51 13007 ENDO MODULAR CERAMIC SH 41 13008 ENDO MODULAR CERAMIC SH 43 13009 ENDO MODULAR CERAMIC SH 45 13010 ENDO MODULAR CERAMIC SH 47 13011 ENDO MODULAR CERAMIC SH 49 13014 ENDO MODULAR CERAMIC MD 41 13015 ENDO MODULAR CERAMIC MD 43 13016 ENDO MODULAR CERAMIC MD 45 13017 ENDO MODULAR CERAMIC MD 47 13018 ENDO MODULAR CERAMIC MD 49 14823 ENDO MODULAR CERAMIC SH 53 14824 ENDO MODULAR CERAMIC MD 53 14825 ENDO MODULAR CERAMIC SH 55 14826 ENDO MODULAR CERAMIC MD 55 17295 ENDO MODULAR CERAMIC SH 36 17296 ENDO MODULAR CERAMIC MD 36
Lot/Code Info: Product ID/UDI-DI 13006 M20913006 13012 M20913012 13013 M20913013 13019 M20913019 13007 M20913007 13008 M20913008 13009 M20913009 13010 M20913010 13011 M20913011 13014 M20913014 13015 M20913015 13016 M20913016 13017 M20913017 13018 M20913018 14823 M20914823 14824 M20914824 14825 M20914825 14826 M20914826 17295 M20917295 17296 M20917296 All lots, all serial numbers
Quantity Affected: 147 total
Reason for Recall
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
Distribution
US Domestic distribution to Texas and Michigan.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-09-09
Company
Port Huron, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 237 device recalls issued in the same week, part of 403 device-related FDA actions this month.
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (BioPro, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does BioPro, Inc. have FDA actions?
BioPro, Inc. has 16 FDA actions in our database, including 16 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0152-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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