Data Foundry

Medical device recalls 2018

Disposable Smooth Interior Tubing Material: Polyethylene EVA copolymer — Class II medical device recall Z-0120-2019

Terminated recall by A M Systems Inc, reported 2018-10-24, distributed in NC, OH, PA. Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Recall numberZ-0120-2019
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmA M Systems Inc, Sequim, WA, United States
Recall initiated2018-08-10
Classified2018-10-16
Reported by FDA2018-10-24
Terminated2021-05-13
DistributedNC, OH, PA
Quantity610
Lot numbers572015, 574717, 578973, 579100, 582567

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.

Reason for recall

Some of the Disposable Smooth Interior Tubing may pull apart when stretched.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0120-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.