Product Name: HIGH FLOW INSUFFLATION TUBING — Class II medical device recall Z-2408-2024
Ongoing recall by Canadian Hospital Specialties Ltd., reported 2024-07-24, distributed nationwide. A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile pro
| Recall number | Z-2408-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Canadian Hospital Specialties Ltd., Oakville, Canada |
| Recall initiated | 2024-06-11 |
| Classified | 2024-07-17 |
| Reported by FDA | 2024-07-24 |
| Distributed | Nationwide (US) |
| Quantity | 6,300 units |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00628725004358, 50628725004353 |
| Lot numbers | 185198 |
| Model numbers | 20400161S |
Product
Product Name: HIGH FLOW INSUFFLATION TUBING (with Filter) Model/Catalog Number: 20400161S Product Description: Laparoscopic Insufflator
Reason for recall
A customer found product with incomplete seals of P/N 20400161S, lot #185198 which can lead to non-sterile product and patient safety concerns. CHS has validated this complaint.
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-2408-2024. 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.