Custom medical procedure packs labeled as recallZ-2089-2023 · 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-2089-2023
- Status
- Open, Classified
- Initiated by the company
- May 30, 2023
- Posted by the FDA
- Jul 3, 2023
- Recalling firm
- DeRoyal Industries Inc
- Quantity
- 3 packs
- Product code
- MLT
- Distribution
- US Nationwide distribution.
Product description
Custom medical procedure packs labeled as: a) PELVIC EXAM TRAY, REF 89-6219
Code information (models, lots, serial numbers)
a) REF 89-6219, GTIN 50749756664382 (cs), 00749756664387 (unit), Lot Numbers: 58807114
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- DeRoyal 89-6219Deroyal Industries, Inc. · Pelvic exam kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 92445).
- Z-2086-2023 · Open, ClassifiedCustom 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, …
- 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-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.
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