Kii Fios First Entry — Class II medical device recall Z-1959-2019

Terminated recall by Applied Medical Resources Corp, reported 2019-07-17, distributed nationwide. The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the

Recall number	`Z-1959-2019`
Product type	Medical device
Classification	Class II
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Applied Medical Resources Corp, Rancho Santa Margarita, CA, United States
Recall initiated	2019-01-28
Classified	2019-07-11
Reported by FDA	2019-07-17
Terminated	2020-06-12
Distributed	Nationwide (US)
Countries outside the US	AU, DE, ES, FI, FR, GB, IT, JP, NZ
Quantity	2,016 units
Reason classes	sterility
Lot numbers	`1330981`
Model numbers	`CFF05`
Expiration dates	`2021-07-15`

Product

Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a path of entry or to gain access through tissue planes and/or potential spaces for endoscopic instruments, and as a means of insufflating the peritoneum prior to laparoscopic procedures.

Reason for recall

The product may not have met sterility requirements . Use of a non-sterile device on a patient may expose the patient to infectious agents.

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-1959-2019. 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.