Class II — the FDA judged the product may cause temporary or medically reversible harm, with a remote chance of serious harm.
This is the FDA's risk judgment for this recall. It describes the potential of the product as a category — it does not establish that any specific unit harmed anyone. Most recalls are Class II or III.
BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM 18134 BIPOLAR HEAD 42MM 18135 BIPOLAR HEAD 43MM 18136 BIPOLAR HEAD 44MM 18137 BIPOLAR HEAD 45MM 18138 BIPOLAR HEAD 46MM 18139 BIPOLAR HEAD 47MM 18140 BIPOLAR HEAD 48MM 18141 BIPOLAR HEAD 49MM 18142 BIPOLAR HEAD 50MM 18143 BIPOLAR HEAD 51MM 18144 BIPOLAR HEAD 52MM 18145 BIPOLAR HEAD 53MM 18146 BIPOLAR HEAD 54MM 18147 BIPOLAR HEAD 55MM 18148 BIPOLAR HEAD 56MM 18149 BIPOLAR HEAD 57MM 18150 BIPOLAR HEAD 58MM 18151 BIPOLAR HEAD 59MM 18152 BIPOLAR HEAD 60MM
Why it was recalled
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.
Is your unit affected?
The recall covers only the specific lots or serial numbers the FDA listed. Enter the lot or serial number from your product's label and we'll check it against that list.
A match means your unit may be covered — stop and call your pharmacist before doing anything. No match suggests it isn't covered, but confirm anyway: code formats vary and lists can be incomplete. Your unit not being listed does not guarantee it is safe, and being listed does not mean you have been harmed.
Show the FDA's listed lot / code information
Product ID/UDI-DI 18130 M20918130 18131 M20918131 18132 M20918132 18133 M20918133 18134 M20918134 18135 M20918135 18136 M20918136 18137 M20918137 18138 M20918138 18139 M20918139 18140 M20918140 18141 M20918141 18142 M20918142 18143 M20918143 18144 M20918144 18145 M20918145 18146 M20918146 18147 M20918147 18148 M20918148 18149 M20918149 18150 M20918150 18151 M20918151 18152 M20918152 All lots, all serial numbers
Recall status
Ongoing — the recall is still being carried out.
Where it was distributed
US Domestic distribution to Texas and Michigan.
Recall record
- Recalling firm
- BioPro, Inc.
- Product type
- Devices
- Recall number
- Z-0150-2026
- Voluntary / mandated
- Voluntary: Firm initiated
- Initial notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Origin
- Port Huron, MI
- Recall initiated
- 2025-09-09
What to do
Check the lot/code above against your product. To confirm this record and read the FDA's full notice, see the FDA recall page. Before changing anything you take or use, ask your pharmacist or prescriber — this page does not tell you to start or stop any drug or device.
Also available: structured data (JSON-LD) · recall record (JSON)
What this is — and is not
A recall is a recorded FDA enforcement action — the FDA logged that a firm is removing or correcting a product. It does not establish that any specific unit harmed anyone, and causation is not established by a recall. The class above is the FDA's risk judgment for the product category, not a finding about your unit. This page informs and compares; it is not medical advice and never tells you to start or stop a drug or device.
To report a problem you experienced, use
FDA MedWatch.
Verify this record at FDA recalls ·
Recall Z-0150-2026 · Source: openFDA enforcement.