# FDA recall Z-2333-2023

> **MEDLINE INDUSTRIES, LP - Northfield** · Class II · device recall initiated 2023-05-15.

## Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel.  Labeled as the following:     a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N;       b. CUSTOM GYN, Model Number: DYNJ63257B;     c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C;    d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F;       e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F;       f. DBD-GYN LS, Model Number: DYNJ906616G;       g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I;       h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D;       i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F;       j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F;       k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K;       l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F;       m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C;       n. ROBOTIC PACK-LF, Model Number: DYNJ904250G;       o. ROBOTIC PROSTATECT

## Reason for recall

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

## Key facts

- **Recall number:** Z-2333-2023
- **Recalling firm:** MEDLINE INDUSTRIES, LP - Northfield
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-15
- **Report date:** 2023-08-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Northfield, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2333-2023

## Citation

> AI Analytics. FDA recall Z-2333-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2333-2023. Source: US FDA. Licensed CC0.

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