MEDLINE INDUSTRIES, LP - Northfield: Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;

Recall number

Z-2169-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;

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

770147 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 CDS840214Q, UDI/DI (EA) 10195327289904, UDI/DI (CS) 40195327289905; b) Model Number DYNDA2418, UDI/DI (EA) 10193489378214, UDI/DI (CS) 40193489378215; c) Model Number DYNJ0365463J, UDI/DI (EA) 10193489783872, UDI/DI (CS) 40193489783873; d) Model Number DYNJ24459P, UDI/DI (EA) 10193489355345, UDI/DI (CS) 40193489355346; e) Model Number DYNJ40629B, UDI/DI (EA) 10888277778696, UDI/DI (CS) 40888277778697; f) Model Number DYNJ44210B, UDI/DI (EA) 10193489306859, UDI/DI (CS) 40193489306850; g) Model Number DYNJ47716C, UDI/DI (EA) 10195327355296, UDI/DI (CS) 40195327355297; h) Model Number DYNJ48520, UDI/DI (EA) 10888277903463, UDI/DI (CS) 40888277903464; i) Model Number DYNJ53059A, UDI/DI (EA) 10889942415113, UDI/DI (CS) 40889942415114; j) Model Number DYNJ59813, UDI/DI (EA) 10888277786455, UDI/DI (CS) 40888277786456; k) Model Number DYNJ61747C, UDI/DI (EA) 10193489365030, UDI/DI (CS) 40193489365031; l) Model Number DYNJ68027A, UDI/DI (EA) 10195327351144, UDI/DI (CS) 40195327351145; m) Model Number DYNJ81410B, UDI/DI (EA) 10195327320829, UDI/DI (CS) 40195327320820; n) Model Number DYNJ82517, UDI/DI (EA) 10195327198640, UDI/DI (CS) 40195327198641; o) Model Number DYNJ83966, UDI/DI (EA) 10195327320423, UDI/DI (CS) 40195327320424; p) Model Number DYNJ906915, UDI/DI (EA) 10193489280371, UDI/DI (CS) 40193489280372; q) Model Number DYNJ908046C, UDI/DI (EA) 10195327313494, UDI/DI (CS) 40195327313495; r) Model Number PHS751646C, UDI/DI (EA) 10889942245352, UDI/DI (CS) 40889942245353; s) Model Number PHS751646D, UDI/DI (EA) 10195327196806, UDI/DI (CS) 40195327196807;

510(k) numbers

not on file

PMA numbers

not on file

Product code

FDE

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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