---
title: "BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic he... — FDA record Z-0148-2026 | 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-0148-2026-biopro-femoral-head-metal-22-28-32-36-40-cobalt-chromium-and-ceramic-heads-part-id-description-18593/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# BioPro Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMO... — FDA record Z-0148-2026

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 Femoral Head (Metal 22, 28, 32, 36, 40) cobalt chromium and ceramic heads Part ID/Description: 18593 HEAD FEMORAL 22MM -3 18594 HEAD FEMORAL 22MM +0 19003 HEAD FEMORAL 28MM-6 19004 HEAD FEMORAL 28MM-3 19005 HEAD FEMORAL 28MM+0 19006 HEAD FEMORAL 28MM+3 19007 HEAD FEMORAL 28MM+6 19008 HEAD FEMORAL 28MM+9 19053 HEAD FEMORAL 36MM -3 19054 HEAD FEMORAL 36MM +0 19055 HEAD FEMORAL 36MM +3 19056 HEAD FEMORAL 36MM +6 19057 HEAD FEMORAL 36MM +9 19130 HEAD FEMORAL 32MM-6 19131 HEAD FEMORAL 32MM-3 19132 HEAD FEMORAL 32MM+0 19133 HEAD FEMORAL 32MM +3 19134 HEAD FEMORAL 32MM+6 19135 HEAD FEMORAL 32MM +9
- **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-0148-2026

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0148-2026%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 | Part ID/ UDI-DI: 18593 M20918593 18594 M20918594 19003 M20919003 19004 M20919004 19005 M20919005 19006 M20919006 19007 M20919007 19008 M20919008 19053 M20919053 19054 M20919054 19055 M20919055 19056 M20919056 19057 M20919057 19130 M20919130 19131 M20919131 19132 M20919132 19133 M20919133 19134 M20919134 19135 M20919135 All lots and serial numbers affected |

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-0148-2026%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [BioPro, Inc. records](https://isitonrecall.com/brand/biopro-inc/)