# FDA recall Z-2317-2023

> **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. (54) KIT STC PLASTIC FREE FLAP, Model Number: DYNJ909031;       b. BREAST, Model Number: DYNJ904598B;     c. BREAST DBL PROCED SUPPLEMENT, Model Number: DYNJ63893;       d. BREAST PACK, Model Number: DYNDH1306;       e. BRST BX TRAY, Model Number: DYNDH1389B;       f. CMC BREAST BIOPSY TRAY-LF, Model Number: DYNJ61084A;       g. DBD-DIEP PACK, Model Number: DYNJ60669F;       h. DBD-FREE FLAP, Model Number: DYNJ907802;       i. DBD-FREE FLAP PACK, Model Number: DYNJ83286;       j. DBD-MAJOR BREAST, Model Number: DYNJ905004B;       k. DBD-PLASTICS FREE FLAP, Model Number: SYNJ910024A;       l. DELNOR SIMPLE PLASTIC PACK, Model Number: DYNJ82250;       m. DIEP, Model Number: DYNJ905702C, DYNJ905702D;       n. DIEP FLAP CDS, Model Number: DYNJ904762D;       o. DIEP PACK, Model Number: DYNJ60669C, DYNJ60669D;       p. FH BREAST FLAP PACK, Model Number: DYNJ58272C, DYNJ58272D; 

## 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-2317-2023
- **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-2317-2023

## Citation

> AI Analytics. FDA recall Z-2317-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2317-2023. Source: US FDA. Licensed CC0.

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