Neuro IR Tray recalled over unconfirmed sterilization assurance
American Contract Systems Inc is recalling Neuro IR Tray (Model WENI56J) due to inability to confirm sterilization assurance. Loss of functionality could delay or prolong treatment.
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 risk-of-harm medical device where sterilization assurance cannot be confirmed, but no injuries or illnesses have been reported. The Class II classification and potential for loss of functionality in a surgical setting support a High severity rating.
Plain-English summary
American Contract Systems Inc is recalling 120 kits of the Neuro IR Tray, Model No WENI56J, distributed nationwide in Ohio. The company is unable to confirm that sterilization assurance requirements were met during manufacturing or processing.
If the devices are not properly sterilized, they may experience loss or lack of intended functionality. This could result in treatment delays or prolonged treatment courses for patients receiving care with affected trays.
Healthcare facilities and consumers in possession of affected units should contact American Contract Systems Inc or the FDA for instructions regarding the recalled products and proper handling or return procedures.
The recalled product
- Product
- NEURO IR TRAY , Model No WENI56J
- Manufacturer
- American Contract Systems Inc
- Category
- Medical Device — Surgical Tray
- Affected units
- 120
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 (1)
- UDI-DI 00191072217813 Lots 893241 71-051182 71-051813
Distribution
Part of a larger recall action
This product is one of 32 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 32 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 failure
See all →- HighLaparoscopy Surgical Packs Recalled Due to Unconfirmed Sterilization
FDA (Devices) · 2025-03-26
- HighMedical Paracentesis Kit Recalled Over Sterilization Assurance Failure
FDA (Devices) · 2024-10-02
- HighMedical Device Kit Recall: Sterilization Assurance Cannot Be Confirmed
FDA (Devices) · 2024-10-02
Similar recalls
- HighCranial Surgery Procedure Kit Recalled Over Sterility Assurance Failure
FDA (Devices) · 2025-03-26
- HighAngiography Packs Recalled Due to Sterilization Validation Failure
FDA (Devices) · 2022-09-14
- HighCraniotomy and shunt packs recalled over unjustified sterilization of certain components
FDA (Devices) · 2025-09-03
- HighHysterectomy procedure packs recalled over unconfirmed sterilization assurance requirements
FDA (Devices) · 2025-09-03
- HighEye Surgery Packs Recalled Due to Improper Sterilization Validation
FDA (Devices) · 2022-09-14
- HighBasic biopsy trays recalled after entire lot was sterilized more than once
FDA (Devices) · 2025-10-22