Universal Flex2 Breathing Circuit Class I 510 — Class I medical device recall Z-2272-2013
Terminated recall by King Systems Corp., reported 2013-10-09, distributed nationwide. King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a
| Recall number | Z-2272-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | King Systems Corp., Noblesville, IN, United States |
| Recall initiated | 2012-08-23 |
| Classified | 2013-09-27 |
| Reported by FDA | 2013-10-09 |
| Terminated | 2013-11-18 |
| Distributed | Nationwide (US) |
| Reason classes | labeling |
| Lot numbers | I063N |
| Model numbers | DF4110-61 |
Product
Universal Flex2 Breathing Circuit Class I 510(k) Exempt An anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-piece.
Reason for recall
King Systems received a customer complaint indicating that the customer had ordered a breathing circuit with a Latex breathing bag. The product they received contained a Latex breathing bag, but was labeled as non-latex.
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-2272-2013. 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.