DeRoyal Sterile Custom kits containing Covidien-Dover — Class II medical device recall Z-0334-2018
Terminated recall by DeRoyal Industries Inc, reported 2018-01-24, distributed in CA, MO. DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Pisto
| Recall number | Z-0334-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2017-12-19 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2018-06-21 |
| Distributed | CA, MO |
| Quantity | 226 kits |
| Reason classes | labeling, sterility |
| Lot numbers | 38497294, 38527131, 38564514, 40146320, 40990651, 41450075, 41511034, 41668816, 42143982, 42839390, 44080575, 44108769, 44274020, 44721168, 44871131, 45599133, 45715430, 46232122 |
Product
DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
Reason for recall
DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Machine access
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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.