--- title: "BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPO... — FDA record Z-0150-2026 | Is It on Recall" description: "Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infectio" url: https://isitonrecall.com/recall/fda-device-z-0150-2026-biopro-bipolar-head-product-id-description-18130-bipolar-head-38mm-18131-bipolar-head-39mm-18132-bip/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement # BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18... — FDA record Z-0150-2026 Reported ongoing Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice. Source date Sep 9, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## What the record says - **Product**: 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 - **Reason**: 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. - **Classification**: Class II - **Recalling firm**: BioPro, Inc. - **Quantity**: 147 total - **Agency-reported status**: Ongoing - **Source record identifier**: Z-0150-2026 [Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0150-2026%22) [What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice. ## Lot and product identifiers | Label field | Details supplied by the agency | | --- | --- | | Lot, code or applicability | 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## Distribution US Domestic distribution to Texas and Michigan. States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address. - [Michigan](https://isitonrecall.com/state/michigan/) - [Texas](https://isitonrecall.com/state/texas/) ## Dates in the source - **Report date**: Oct 22, 2025 - **Recall initiation date**: Sep 9, 2025 - **Center classification date**: Oct 14, 2025 FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable. ## What to do next Read the official notice for the action that applies to your exact product. [Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0150-2026%22) ## Related records [Medical devices records](https://isitonrecall.com/category/medical-devices/) [BioPro, Inc. records](https://isitonrecall.com/brand/biopro-inc/)