The Recall Desk
HighFDA (Devices)·Z-1339-2025·Announced 2025-03-26

Open Heart Surgery Kit Sterilization Assurance Cannot Be Confirmed

American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits due to inability to confirm sterilization requirements were met. Unsterilized devices could lose functionality and delay patient treatment.

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: FDA Class II medical device recall with sterilization assurance failure. Potential loss of functionality in surgical instruments is a risk-of-harm hazard. No illnesses or injuries are reported in the source.

Plain-English summary

American Contract Systems Inc is recalling 90 Open Heart Adult Side A surgical kits (Model Nos LLOH01I-01 and LLOH01I). The manufacturer cannot confirm that sterilization assurance requirements were met for these devices.

Unsterilized or improperly sterilized surgical instruments could lose functionality during use, potentially causing delays or prolonged treatment during open heart surgical procedures.

Healthcare facilities using these kits should immediately discontinue use of products with lot numbers 898241, 70-050704, or 70-051731. Contact American Contract Systems Inc for instructions on return or replacement of affected devices.

The recalled product

Product
OPEN HEART ADULT - SIDE A , Model Nos LLOH01I-01 LLOH01I
Manufacturer
American Contract Systems Inc
Category
Medical Device — Surgical Instruments / Open Heart
Hazard
  • sterilization-failure
  • loss-of-functionality

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)

  • UDI-DI 00191072219251 Lots 898241 70-050704 70-051731

Distribution

Distributed nationwide across the United States.

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