DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing — Class II medical device recall Z-2113-2013
Terminated recall by DeRoyal Industries Inc, reported 2013-09-04, distributed nationwide. DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which
| Recall number | Z-2113-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2013-07-15 |
| Classified | 2013-08-28 |
| Reported by FDA | 2013-09-04 |
| Terminated | 2015-05-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, IE, JP |
| Reason classes | device malfunction |
| Lot numbers | 29000354, 29074214, 29074249, 29314302, 3194170, 32305010 |
| Model numbers | 28-0206, 28-0208, 28-0212H, 28-0214, 28-0216, 28-0217 |
Product
DeRoyal Insufflation Tubing sets: 1) REF 28-0206 Insufflation Tubing, Laparoscopic Rx Only 2) REF 28-0214 Hi-Flow Insufflation Tubing Rx Only 3) REF 28-0216 Tubing, Insuf w/.3 Micr Filter Rx Only 4) REF 28-0217 Insufflation Tubing, Laparoscopic Rx Only 5) REF 28-0208 Insufflation Tubing w/Vent Rx Only 6) REF 28-0212H Heated Hi-Flow Insufflation Tubing Rx Only. Used during laparoscopic surgical procedures to aid in the insufflation of the abdomen.
Reason for recall
DeRoyal Industries is recalling their product Insufflation Tubing Sets due to materials incompatibility which could possibly result in occlusion at or near the filter housing which could prevent the flow of gas through the device.
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-2113-2013. 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.