Robotics Pack Sterilization Error Affects IV Catheter and Adhesive Components
American Contract Systems recalls Robotics Pack SAH components due to improper sterilization exposure. The IV catheter and adhesive components may lack functionality or contain excess sterilization residue.
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: Class II medical device recall with potential loss of functionality and chemical residue hazards due to improper sterilization. No injuries or illnesses have been reported, fitting the rubric category of risk-of-harm products where injury has not yet been reported.
Plain-English summary
American Contract Systems, Inc. is recalling Robotics Pack SAH units (REF SAR530M) due to improper sterilization of internal components. The affected components are the I.V. Catheter (part number 4252535-02) and Adhesive Dermabond (part number DHVM12). A total of 96 cases have been distributed in Florida and Iowa.
During an internal investigation, the company discovered that these components were inadvertently subjected to ethylene oxide sterilization at temperatures higher than those approved by the component manufacturer. As a result, the components may experience loss or lack of functionality, loss of drug efficacy (if applicable), and may contain ethylene oxide residuals higher than specified limits.
Affected customers with lot numbers 949231 or 983231 should immediately discontinue use of the product and contact American Contract Systems for replacement or further instructions. Verify the lot number and UDI (00191072179678) on your unit to determine if it is affected.
The recalled product
- Product
- Robotics Pack SAH, REF SAR530M
- Manufacturer
- American Contract Systems, Inc.
- Affected units
- 96
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/DI00191072179678
- Lot Numbers: 949231
- 983231
Distribution
Part of a larger recall action
This product is one of 12 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 12 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 · loss of function
See all →- HighKME Recalls 2024 CV515 SFA 4x4 and Severe Service Emergency Vehicles
NHTSA · 2026-10-06
- HighPhilips Fluoroscopy System Recall Over Hard Disk Drive Issue
FDA (Devices) · 2026-08-12
- SeverePhilips Allura X-Ray Systems Recalled Over Unauthorized Hard Disk Drives
FDA (Devices) · 2026-08-12
- HighOlympus High Flow Insufflation Unit UHI-4 Recalled Due to Display and Air Delivery Failure
FDA (Devices) · 2026-07-29
- HighInterventional fluoroscopy systems recalled over control board corrosion affecting imaging
FDA (Devices) · 2025-10-29
Similar recalls
- HighArthroscopy Pack Recalled for Excessive Sterilization Chemical Residue
FDA (Devices) · 2024-07-17
- ModerateACS Cath Lab Packs Sterilized with Excess Ethylene Oxide
FDA (Devices) · 2022-05-18
- HighACS IR Angio Pack Sterilization Process Defect Recall
FDA (Devices) · 2022-05-18
- HighSpine Surgery Instrument Sets Recalled for Sterilization Defect
FDA (Devices) · 2022-05-18
- HighArthroscopy Kit Recalled for Excessive Sterilant Residue on Padding
FDA (Devices) · 2024-07-17
- HighArthroscopy Procedure Kit Recalled Due to Ethylene Oxide Residue
FDA (Devices) · 2024-07-17