Regard ¿ custom surgical pack labeled as "LAP — Class II medical device recall Z-2220-2019
Ongoing recall by ROi Consolidated Service Center (CSC), reported 2019-08-14, distributed in LA, MO. Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potenti
| Recall number | Z-2220-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ROi Consolidated Service Center (CSC), Springfield, MO, United States |
| Recall initiated | 2019-03-21 |
| Classified | 2019-08-08 |
| Reported by FDA | 2019-08-14 |
| Distributed | LA, MO |
| Quantity | 261 packages |
| Reason classes | packaging, device malfunction |
| Model numbers | 040, 0620, 660, 800096004, 800096005 |
Product
Regard ¿ custom surgical pack labeled as "LAP - FLOL LADY OF ANGELS" including recalled Stryker part numbers 0620 040 660 Pneumosure High Flow II Tubeset, 0620 040 690 Pneumosure Heated Tubeset with RTP and 0620 040 680 Pneumosure High Flow Tubeset with RTP.
Reason for recall
Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.
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-2220-2019. 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.