Cardiac Surgical Training Kits Recalled for Sterilization Verification Failure
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits (Models UTOH19AI, UTOH19AJ-01, UTOH19AJ-02) because sterilization assurance requirements cannot be confirmed. Lack of sterilization could impair functionality.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: This is an FDA Class II device recall of a risk-of-harm product (cardiac surgical training equipment) where sterilization assurance cannot be confirmed. No illnesses or injuries have been reported, and the hazard is unconfirmed potential loss of functionality.
Plain-English summary
American Contract Systems Inc is recalling OPEN HEART A PACK surgical training kits distributed nationwide in Ohio. The recalled models are UTOH19AI, UTOH19AJ-01, and UTOH19AJ-02. The manufacturer is unable to confirm that sterilization assurance requirements were met during production.
Sterile medical devices require sterilization to prevent infection and ensure proper functionality. If sterilization assurance cannot be confirmed, the kits may lose functionality or fail to operate as intended, potentially delaying or prolonging medical training or procedures.
No injuries or illnesses have been reported. Consumers who received these kits should discontinue use and contact American Contract Systems Inc for replacement or refund information.
The recalled product
- Product
- OPEN HEART A PACK , Model No UTOH19AI UTOH19AJ-01 UTOH19AJ-02
- Manufacturer
- American Contract Systems Inc
- Affected units
- 54
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 00191072184450 00191072221070 Lots 921241 70-051173 70-052439
Distribution
Part of a larger recall action
This product is one of 32 recalled by American Contract Systems Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 32 products in this recall →Related recalls
Same manufacturer · American Contract Systems Inc
See all →- SevereFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighFDA Recalls Medical Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- HighRecall of Medical Convenience Kits with Contaminated Pericare Wipes
FDA (Devices) · 2026-10-07
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
Same hazard · sterilization failure
See all →- SevereSteris VERIFY Biological Indicator Recall Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
- HighSteris VERIFY Dual Species Biological Indicator Recall for Spore Population Issues
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological Steam Test Pack Recalled for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris VERIFY Biological/Integrator Challenge Pack Recall for Spore Population Defect
FDA (Devices) · 2026-10-14
- SevereSteris Recalls VERIFY Biological Steam Test Packs Due to Spore Population Concerns
FDA (Devices) · 2026-10-14
Similar recalls
- HighHeart and vascular packs recalled because sterilization rationale was not justified
FDA (Devices) · 2025-09-03
- HighCardiovascular procedure packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22
- HighPacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation
FDA (Devices) · 2022-09-14
- HighCath Cardiac Pack sterilization failure may cause loss of functionality
FDA (Devices) · 2023-11-01
- HighCardiac central line insertion kits lack documented sterilization validation
FDA (Devices) · 2024-02-07
- HighCardiac catheterization packs recalled after being sterilized more than once
FDA (Devices) · 2025-10-22