The Recall Desk
HighFDA (Devices)·Z-0153-2026·Announced 2025-10-22

Femoral head implants recalled over packaging that may compromise sterile barrier

BioPro is recalling 147 femoral head implants over a potential packaging issue that could compromise the sterile barrier and present a risk of infection if implanted.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Scored 3 under the risk-of-harm criterion: a compromised sterile barrier on an implant creates an infection risk, and no injuries are reported.

Plain-English summary

BioPro Femoral Heads are being recalled, covering product IDs 14089 (28 SH LT), 14090 (28 MD LT), 14091 (28 LG LT), 14094 (32 SH LT), 14095 (32 MD LT) and 14096 (32 LG LT).

There is a potential packaging issue that could compromise the sterile barrier. The defect may result in loss of sterility of the device, presenting a potential risk of infection if the device is implanted.

The recall covers 147 units, distributed to Texas and Michigan. The FDA has classified the action as Class II.

The enforcement record describes the packaging issue and reports no injuries. Facilities should quarantine affected stock and follow BioPro's instructions.

The recalled product

Product
BioPro Femoral Head Product ID/Description 14089 HEAD FEMORAL 28 SH LT 14090 HEAD FEMORAL 28 MD LT 14091 HEAD FEMORAL 28 LG LT 14094 HEAD FEMORAL 32 SH LT 14095 HEAD FEMORAL 32 MD LT 14096 HEAD FEMORAL 32 LG LT
Manufacturer
BioPro, Inc.
Category
Medical Device — Orthopedic implant
Hazard
  • sterile-barrier-breach
  • packaging-defect
  • infection-risk
  • implant

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • all serial numbers

Distribution

Distribution scope not specified by the agency.

Related recalls

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