American Contract Systems Recalls Open Shoulder Medical Convenience Kits
American Contract Systems is recalling 12 Open Shoulder medical convenience kits because a faulty chart recorder prevented verification of sterilization requirements.
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: The recall involves a medical device where sterilization assurance cannot be confirmed, creating a risk of harm (infection) without reported injuries, which aligns with the 'High' severity criteria for risk-of-harm products.
Plain-English summary
American Contract Systems, Inc. is recalling 12 units of the Open Shoulder, LWOS39L medical convenience kit. The recall was initiated because the company identified an inoperable chart recorder in one of its controlled environment areas. This malfunction resulted in humidity readings that were out of specification, meaning the company cannot confirm that the product met sterilization assurance requirements.
The affected products have the UDI-DI 00191072177032, Lot 2405141, and an expiration date of 05/14/2025. These units were distributed nationwide in the states of Missouri, Minnesota, Massachusetts, Ohio, and Nebraska.
Healthcare facilities and consumers should stop using these specific kits and contact American Contract Systems for instructions on how to return or dispose of the product.
The recalled product
- Product
- Open Shoulder, LWOS39L; Medical convenience kit
- Manufacturer
- American Contract Systems, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 12
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: 00191072177032
- Lot: 2405141
- Exp: 05/14/2025
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 →- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kit Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract Systems Recalls Convenience Kits with Non-Conforming Catheters
FDA (Devices) · 2026-09-02
- ModerateAmerican Contract System Convenience Kits Recalled for Performance Failures
FDA (Devices) · 2026-09-02
- HighMedicom Recalls Neurological Sponges Due to Endotoxin Variability
FDA (Devices) · 2026-08-26
Same hazard · sterilization failure
See all →- HighOlympus Toomey Evacuator 50cc with Adaptor sterilization recall
FDA (Devices) · 2026-07-22
- HighOlympus Glass Body for 194 Ellik Evacuator Model 190A Sterilization Recall
FDA (Devices) · 2026-07-22
- HighVasoview Hemopro 2 Endoscopic Vessel Harvesting System Recall
FDA (Devices) · 2026-07-22
- SevereOlympus Ellik Evacuator Recalled for Inadequate Sterilization Risk
FDA (Devices) · 2026-07-22
- HighOlympus Toomey Evacuator 30cc medical device sterilization parameters recalled
FDA (Devices) · 2026-07-22