Class II — A M Systems Inc
| Recalling firm | A-M SYSTEMS, LLC |
|---|---|
| Registered facility | A-M Systems (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Some of the Disposable Smooth Interior Tubing may pull apart when stretched. |
| Product | Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer. This tubing is supplied non-sterile P/N: 1024920 Rev. 01 Low temperature smooth interior tubing is a disposable pulmonary equipment interconnect used in ventilation and aesthesia machines. |
| Quantity | 610 |
| Distribution | US Distribution to states of: OH, PA, and NC. |
| Initiated | 2018-08-10 |
| Classified | 2018-10-16 |
| Terminated | 2021-05-13 |
| Recall number | Z-0120-2019 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — A M Systems Inc (Z-0120-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/81076/
Alerts for A-M SYSTEMS, LLC
Watchlist alerts will email you when FDA publishes a new recall, inspection classification, or warning letter for a facility you follow. They aren't open to the public yet — leave your email and we'll tell you when they are.
Want a one-page facility brief?
A single-page summary of this facility's registration and recall history for diligence. Not selling it yet — register interest and we'll follow up.