# FDA recall Z-2086-2023

> **DeRoyal Industries Inc** · Class II · device recall initiated 2023-05-30.

## 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  V

## Reason for recall

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2086-2023
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-30
- **Report date:** 2023-07-12

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2086-2023

## Citation

> MORVS. FDA recall Z-2086-2023. Retrieved 2026-10-20 from https://api.morvs.ai/recall/Z-2086-2023. Source: US FDA. Licensed CC0.

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*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*