Cardiac surgical kits recalled due to improper sterilization exposure
American Contract Systems is recalling 12,291 cardiac procedure kits nationwide. Components were exposed to sterilization without documented assessment of suitability, potentially causing loss of functionality or efficacy.
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: This is an FDA Class II recall involving high-risk cardiac surgical kits where improper sterilization exposure may cause loss of functionality or drug efficacy. No illnesses or injuries have been reported. Per the recall rubric, risk-of-harm products where injury has not yet occurred score as High (3).
Plain-English summary
American Contract Systems, Inc. is recalling cardiac procedural convenience kits and trays distributed nationwide. The recall involves 12,291 units across multiple kit models.
During an internal investigation, ACS identified that several components were added to ACS trays and subjected to the company's sterilization process. There is no supporting documentation confirming that these components were assessed for suitability to exposure to elevated temperatures for an extended period and sterilization exposure. As a result, the components may have: (1) loss or lack of functionality, (2) loss of drug efficacy if applicable, and (3) higher than specified ethylene oxide residuals.
The recall encompasses numerous kit models including EP Lab, Vascular, Open Heart, Pacemaker, and Thoracoscopy packs, with specific lot numbers and expiration dates identified for each model.
The recalled product
- Product
- Procedural convenience kits and trays, cardiac, labeled as: a) EP LAB BI V IMPLANT PACK, kit number AGBI64J; b) LAB DEVICE IMPLANT, kit number AGDI40J; c) LAB DEVICE IMPLANT, kit number AGDI40K; d) MINOR VASCULAR, kit number AGMV26O; e) OPEN HEART ACCESSORY, kit number
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-failure
- functionality-loss
- efficacy-loss
- eo-residuals
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 (20)
- a) AGBI64J
- UDI/DI 0019107247578
- Lot numbers: 956231
- exp. 2/13/2024
- 674221
- exp. 11/22/2023
- 699221
- exp. 10/28/2023
- 727221
- exp. 9/30/2023
- 731221
- exp. 9/26/2023
- 769221
- exp. 8/19/2023
- 876221
- exp. 5/4/2023
- b) AGDI40J
- UDI/DI 00191072154668
- exp. 7/31/2023
- 647221
Distribution
Distributed nationwide across the United States.
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