Pacemaker COPM11B Medical Kits Recalled for Sterilization Verification Issue
American Contract Systems is recalling 3 units of the COPM11B pacemaker medical kits due to inability to confirm sterilization requirements were met. An inoperable chart recorder caused humidity readings to exceed specifications during manufacturing.
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 a Class II medical device recall involving inability to verify sterilization requirements. Sterilization assurance failures represent a high-risk hazard for patient safety. However, no illnesses, injuries, or deaths have been reported to date, so the hazard remains theoretical.
Plain-English summary
American Contract Systems, Inc. is recalling 3 units of the Pacemaker COPM11B Medical convenience kit distributed nationwide in Missouri, Minnesota, Massachusetts, Ohio, and Nebraska. The affected units are identified by Lot 2405033 with an expiration date of 05/03/2025.
The recall was initiated because an inoperable chart recorder failed to properly monitor humidity levels in one of the controlled environment areas used during manufacturing. Humidity readings fell out-of-specification, and as a result, the manufacturer is unable to confirm that product sterilization assurance requirements were met.
Sterilization assurance is critical for medical devices to ensure patient safety. Patients or healthcare providers who have received this product should contact American Contract Systems, Inc. for further instructions regarding return or replacement of the affected units.
The recalled product
- Product
- Pacemaker, COPM11B; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Hazard
- sterilization-assurance
- contamination-risk
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 (3)
- UDI-DI: 00191072206312
- Lot: 2405033
- Exp: 05/03/2025
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalMedline spinal anesthetic kits recalled for quality and efficacy concerns
FDA (Devices) · 2026-06-03
- SevereMedline spinal anesthesia kits recalled for bupivacaine quality issues
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Trays Recalled Due to Quality and Efficacy Concerns
FDA (Devices) · 2026-06-03
- HighMedline Medical Convenience Kit Recalled: Wrong Syringe Type Inside
FDA (Devices) · 2026-06-03
- SevereMedline Spinal Block Kits Recalled for Data Integrity and Efficacy Issues
FDA (Devices) · 2026-06-03