Custom medical procedure packs labeled as: a) OPEN HEART TRACECART — Class II medical device recall Z-2086-2023
Ongoing recall by DeRoyal Industries Inc, reported 2023-07-12, distributed nationwide. The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
| Recall number | Z-2086-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | DeRoyal Industries Inc, Powell, TN, United States |
| Recall initiated | 2023-05-30 |
| Classified | 2023-07-03 |
| Reported by FDA | 2023-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 4,225 packages |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00749756214735, 00749756350136, 00749756363129, 00749756363983, 00749756591522, 00749756636735, 00749756686426, 00749756736404, 00749756736695, 00749756741415, 00749756807296, 00749756818483, 00749756836920, 00749756840095, 00749756848336, 00749756864671, 00749756927598, 00749756927666, 00749756938006, 00749756945035, 00749756980128, 50749756214730, 50749756350131, 50749756363124, 50749756363988 and 18 more |
| Lot numbers | 58697963, 58698042, 58698907, 58698974, 58701598, 58714313, 58736862, 58737081, 58738315, 58745371, 58746278, 58762104, 58774885, 58777761, 58789260, 58789411, 58800174, 58808416, 58810330, 58811834, 58823595, 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383 |
Product
Custom medical procedure packs labeled as: a) OPEN HEART TRACECART, REF '53-1941; b) CARDIAC CATH PACK, REF '89-10045; c) SHOULDER PACK, REF '89-10115; d) MINOR ORTHO PACK, REF '89-10213; e) TOTAL KNEE PACK PGYBK, REF '89-10505; f) ANTERIOR HIP PACK PGYBK, REF '89-10563; g) ORTHO X-RAY PACK, REF '89-1495; h) GU PACK, REF '89-4479; i) BREAST PACK, REF '89-5424; j) SHOULDER ARTHROSCOPY PK, REF '89-6606; k) GYN PACK, REF '89-7369; l) ENT PACK, REF '89-7378; m) TOTAL HIP PACK PGYBK, REF '89-7540; n) EPIDURAL TRAY/CUSTOM, REF '89-8061; o) BREAST BIOPSY TRAY, REF '89-8187; p) BEACH CHAIR PACK, REF '89-8439; q) TOTAL KNEE PACK PGYBK, REF '89-8445; r) CYSTO PACK, REF '89-8482; s) SINGLE BASIN PLUS, REF '89-9131; t) TOTAL HIP PACK, REF '89-9287; u) ARTHROSCOPY PACK, REF '89-9626; v) SHOULDER PACK, REF '89-9632 CYSTO PACK, REF '89-10049 BEACH CHAIR SHOULDER PACK, REF '89-10721 EXTREMITY PACK, REF '89-10959 HYSTEROSCOPY PACK, REF '89-10960 VERITHENA VENOUS ABLATION PACK, REF '89-10977 CYSTO BASIN SET, REF '89-2577 OPEN HEART PACK, REF '89-8572 BACK PACK, REF '89-9292
Reason for recall
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
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-2086-2023. 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.