MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2335-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

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;

Product Classification:

Class II

Date Initiated: May 15, 2023

Date Posted: August 9, 2023

Recall Number: Z-2335-2023

Event ID: 92399

Reason for Recall:

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

Status: Ongoing

Product Quantity: 6,340 kits

Code Information:

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ63257C, UPC Number: 019348993830. b. Model Number: DYNJ906578C, UPC Number: 019532702355. c. Model Number: DYNJ9048708I, UPC Number: 019532707273. d. Model Number: PHS762887001B, UPC Number: 088994284931. e. Model Number: DYNJ32988, UPC Number: 088438924278. f. Model Number: DYNJ55361, UPC Number: 088994254669; Model Number: DYNJ55361A, UPC Number: 019532717352. g. Model Number: OBQ056E, UPC Number: 088827758937. h. Model Number: TVS4700, UPC Number: 081698202339.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated