MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Recall number

Z-2177-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST PACK, Model Number DYNDH1306; b) BRST BX TRAY, Model Number DYNDH1389B; c) PLASTIC PACK, Model Number DYNJ35262A; d) VNUS RFS PROCEDURE PACK, Model Number DYNJ39508A; e) FACELIFT PACK, Model Number DYNJ55954C; f) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893; g) BREAST DBL PROCED SUPPLEMENT, Model Number DYNJ63893A; h) PLASTIC FREE FLAP, Model Number DYNJ67367; i) MAJOR BREAST PACK, Model Number DYNJ67381; j) RR-FACIAL FEMINIZATION PACK, Model Number DYNJ68321B; k) DELNOR SIMPLE PLASTIC PACK, Model Number DYNJ82250; l) PK GEN BREAST RESTON, Model Number DYNJ84305; m) BREAST, Model Number DYNJ904598B; n) MINOR BREAST, Model Number DYNJ905002B; o) MAJOR BREAST, Model Number DYNJ905004B; p) MAJOR BREAST, Model Number DYNJ905004C; q) MAJOR BREAST, Model Number DYNJ908890; r) MAJOR BREAST, Model Number DYNJ908890A; s) MINOR BREAST, Model Number DYNJ908892; t) MINOR BREAST, Model Number DYNJ908892A

Status

Open, Classified

Initiated

2023-05-18

Posted

2023-07-20

Terminated

not on file

Reason

Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.

Root cause

Device Design

Action

Medline distributed their recall notices to their consignees beginning on 05/18/2023 by letter. The notices explained the problem, and the risk and requested the destruction of the products. Distributors were directed to notify their consignees, have the customers document and destroy any affected product, and include your customers quantities on the response form. Beginning on 05/23/2023, Medline issued another notice to a separate group of consignees requesting that the kits be over labeled. Distributors were directed to notify the customers and have them return any affected product to the distributor for collection and return to Medline. Questions: please contact the Recall Department at 866-359-1704

Quantity

4398 units

Distribution

Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.

Lot, serial or model codes

all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number DYNDH1306, UDI/DI 10889942771523, UDI/DI 40889942771524; b) Model Number DYNDH1389B, UDI/DI 10193489449181, UDI/DI 40193489449182; c) Model Number DYNJ35262A, UDI/DI 10193489903430, UDI/DI 40193489903431; d) Model Number DYNJ39508A, UDI/DI 10889942628919, UDI/DI 40889942628910; e) Model Number DYNJ55954C, UDI/DI 10193489855791, UDI/DI 40193489855792; f) Model Number DYNJ63893, UDI/DI 10193489771565, UDI/DI 40193489771566; g) Model Number DYNJ63893A, UDI/DI 10195327316891, UDI/DI 40195327316892; h) Model Number DYNJ67367, UDI/DI 10193489895711, UDI/DI 40193489895712; i) Model Number DYNJ67381, UDI/DI 10193489896534, UDI/DI 40193489896535; j) Model Number DYNJ68321B, UDI/DI 10195327283346, UDI/DI 40195327283347; k) Model Number DYNJ82250, UDI/DI 10195327181758, UDI/DI 40195327181759; l) Model Number DYNJ84305, UDI/DI 10195327349813, UDI/DI 40195327349814; m) Model Number DYNJ904598B, UDI/DI 10889942946358, UDI/DI 40889942946359; n) Model Number DYNJ905002B, UDI/DI 10195327316860, UDI/DI 40195327316861; o) Model Number DYNJ905004B, UDI/DI 10193489782585, UDI/DI 40193489782586; p) Model Number DYNJ905004C, UDI/DI 10195327316938, UDI/DI 40195327316939; q) Model Number DYNJ908890, UDI/DI 10195327203399, UDI/DI 40195327203390; r) Model Number DYNJ908890A, UDI/DI 10195327259532, UDI/DI 40195327259533; s) Model Number DYNJ908892, UDI/DI 10195327204037, UDI/DI 40195327204038; t) Model Number DYNJ908892A, UDI/DI 10195327259556, UDI/DI 40195327259557;

510(k) numbers

not on file

PMA numbers

not on file

Product code

FTN

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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