Custom medical procedure packs labeled as recallZ-2086-2023 · DeRoyal Industries Inc · initiated May 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DeRoyal Industries Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.
FDA root cause category: Process control
What the company is doing
DeRoyal disseminated an URGENT! DEROYAL RECALL NOTICE to its consignees on 05/30/2023 by email. The notice explained the issue, the risk, and requested the return of the affected products. Distributors were also directed to identify and notify their customers.
Recall details
- Recall number
- Z-2086-2023
- Status
- Open, Classified
- Initiated by the company
- May 30, 2023
- Posted by the FDA
- Jul 3, 2023
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 4225 packs
- Product code
- LRO
- FDA submissions
- K842648
- Distribution
- US Nationwide distribution.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (2k characters)
a) REF '53-1941, GTIN 50749756864676 (cs), 00749756864671 (unit), Lot Numbers: 59095817, 59108518, 59132841, 59153079, 59169847, 59185134, 59216471, 59224383; b) REF '89-10045, GTIN 50749756980123 (cs), 00749756980128 (unit), Lot Numbers: 58714313; c) REF '89-10115, GTIN 50749756977901 (cs), 00749756980128 (unit), Lot Numbers: 58746278; d) REF '89-10213, GTIN 50749756350131 (cs), 00749756350136 (unit), Lot Numbers: 58745371; e) REF '89-10505, GTIN 50749756363124 (cs), 00749756363129 (unit), Lot Numbers: 58774885, 58774885; f) REF '89-10563, GTIN 50749756363988 (cs), 00749756363983 (unit), Lot Numbers: 58800174; g) REF '89-1495, GTIN 50749756214730 (cs), 00749756214735 (unit), Lot Numbers: 58762104; h) REF '89-4479, GTIN 50749756591527 (cs), 00749756591522 (unit), Lot Numbers: 58810330; i) REF '89-5424, GTIN 50749756636730 (cs), 00749756636735 (unit) Lot Numbers: 58698974; j) REF '89-6606, GTIN 50749756686421 (cs), 00749756686426 (unit) Lot Numbers: 58698907; k) REF '89-7369, GTIN 50749756736690 (cs), 00749756736695 (unit) Lot Numbers: 58777761; l) REF '89-7378, GTIN 50749756736409 (cs), 00749756736404 (unit) Lot Numbers: 58811834; m) REF '89-7540, GTIN 50749756741410 (cs), 00749756741415 (unit), Lot Numbers: 58737081; n) REF '89-8061, GTIN 50749756807291 (cs), 00749756807296 (unit), Lot Numbers: 58698042; o) REF '89-8187, GTIN 50749756818488 (cs), 00749756818483 (unit), Lot Numbers: 58736862; p) REF '89-8439, GTIN 50749756836925 (cs), 00749756836920 (unit), Lot Numbers: 58823595; q) REF '89-8445, GTIN 50749756840090 (cs), 00749756840095 (unit) Lot Numbers: 58697963; r) REF '89-8482, GTIN 50749756848331 (cs), 00749756848336 (unit), Lot Numbers: 58789411; s) REF '89-9131, GTIN 50749756945030 (cs), 00749756945035 (unit) Lot Numbers: 58808416; t) REF '89-9287, GTIN 50749756938001 (cs), 00749756938006 (unit) Lot Numbers 58789260; u) REF '89-9626, GTIN 50749756927661 (cs), 00749756927666 (unit) Lot Numbers: 58738315 v) REF '89-9632, GTIN 50749756927593 (cs), 00749756927598 (unit) Lot Numbers: 58701598
Devices named in this recall
22 devices in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-10563Deroyal Industries, Inc. · General surgery tray1 recall2 reports
- DeRoyal 89-1495Deroyal Industries, Inc. · General surgery tray1 recall1 report
- DeRoyal 89-10213Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-10505Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-4479Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-5424Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-6606Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-7378Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-7369Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-7540Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8061Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8187Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8439Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8445Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-8482Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 53-1941Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-9632Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-9626Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-9287Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-9131Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-10115Deroyal Industries, Inc. · General surgery tray1 recall0 reports
- DeRoyal 89-10045Deroyal Industries, Inc. · General surgery tray1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92445).
- Z-2087-2023 · Open, ClassifiedCustom medical procedure packs labeled as: a) STURDI STRAINER TRAY STANDARD, REF '89-5014
- Z-2088-2023 · Open, ClassifiedCustom medical procedure packs labeled as: a) STANDARD OB PACK ASCENSION WI, REF 89-10640 b) ANGIO PACK, REF 89-10901 c) BASIN, REF 89-1924 d) CYSTO PACK, REF 89-7133 e) TOTAL HI…
- Z-2089-2023 · Open, ClassifiedCustom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
- Z-2090-2023 · Open, ClassifiedCustom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB PACK, REF 89-9183
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page