# FDA recall Z-2335-2023

> **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. CUSTOM GYN, Model Number: DYNJ63257C;       b. GYN EXP LAPAROTOMY, Model Number: DYNJ906578C;     c. INTRAUTERINE TRNSFUSION -LF, Model Number: DYNJ9048708I;    d. PERI NEURO BLOCK PACK-LF, Model Number: PHS762887001B;       e. PICC TRAY, Model Number: DYNJ32988;       f. SLING PACK-LF, Model Number: DYNJ55361, DYNJ55361A;       g. TRANS VAGINAL TRAY (KW01JF), Model Number: OBQ056E;       h. TVS4700 CUSTOM PACK, Model Number: TVS4700;

## 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-2335-2023
- **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-2335-2023

## Citation

> AI Analytics. FDA recall Z-2335-2023. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2335-2023. Source: US FDA. Licensed CC0.

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