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.
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 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.
- Affected units
- 3
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
Part of a larger recall action
This product is one of 19 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 19 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 assurance
See all →- ModerateMedline Urology Convenience Kits recalled due to sterilization calibration issues
FDA (Devices) · 2026-05-13
- HighLabor and Delivery System Recalled for Sterilization Assurance Issue
FDA (Devices) · 2025-03-26
- HighEndovascular AAA Packs Recalled Due to Sterilization Process Defect
FDA (Devices) · 2024-10-02
Similar recalls
- HighSurgical Convenience Kits Recalled for Potential Sterilization Failure
FDA (Devices) · 2024-08-14
- HighPacemaker and Cardiothoracic Surgical Packs Recalled for Improper Sterilization Validation
FDA (Devices) · 2022-09-14
- HighMedical Procedure Kit Recalled Over Potential Sterilization Compromise
FDA (Devices) · 2024-08-14
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- HighAmerican Contract Systems Cataract Pack Kits Recalled Due to Insufficient Sterilization Aeration
FDA (Devices) · 2024-08-14
- HighCardiac central line insertion kits lack documented sterilization validation
FDA (Devices) · 2024-02-07