RecallRadar

FDA Device recall Z-2333-2023

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel

On 2023-08-09 the FDA classified a Class II recall of Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by Medline Industries Northfield, citing potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-2333-2023
ClassificationClass II
Statusongoing
Initiated2023-05-15
Published2023-08-09
Last updated2026-09-13 11:56 UTC
CompanyMedline Industries Northfield
DistributionUS

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CHN OR DAVINCI PROSTATE, Model Number: DYNJ902540N; b. CUSTOM GYN, Model Number: DYNJ63257B; c. DBD-AMNIOCENTESIS PACK-LF, Model Number: DYNJ0771979C; d. DBD-GYN EXP LAPAROTOMY, Model Number: DYNJ906578F; e. DBD-GYN LITHOTOMY, Model Number: DYNJ906579F; f. DBD-GYN LS, Model Number: DYNJ906616G; g. DBD-ROBOTICS GYN, Model Number: DYNJ905824I; h. GYN EXP LAPAROTOMY, Model Number: DYNJ906578D; i. GYN LITHOTOMY, Model Number: DYNJ906579A, DYNJ906579B, DYNJ906579D, DYNJ906579F; j. GYN LS, Model Number: DYNJ906616A, DYNJ906616B, DYNJ906616C, DYNJ906616D, DYNJ906616F; k. GYN ROBOTIC CUSTOM PACK-LF, Model Number: DYNJ0752001K; l. ROBOTIC, Model Number: DYNJ904343D, DYNJ904343F; m. ROBOTIC GYN SSC, Model Number: DYNJ60009B, DYNJ60009C; n. ROBOTIC PACK-LF, Model Number: DYNJ904250G; o. ROBOTIC PROSTATECTOMY, Model Number: DYNJ905826G; p. ROBOTIC-LF, Model Number: DYNJ904254G, DYNJ904254I; q. ROBOTICS GYN, Model Number: DYNJ905824F, DYNJ905824G, DYNJ905824I; r. SSC GU ROBOTIC PACK, Model Number: DYNJ64027A, DYNJ64027B;

Reason

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

Identifiers

upc019348991666
upc019348942817
upc019348940069
upc019532728963
upc019532728964
upc019532728947
upc019532728972
upc019532721712
upc019348942214
upc019348986153
upc019532721713
upc019348942213
upc019348986167
upc019532702358
upc019532714503
upc019532721728
upc019348978302
upc019348991389
upc019532714890
upc019532705797
upc019532720643
upc019532717379
upc019532728973
upc019532700342
upc019532704701
upc019532702351
upc019532721704
upc019532705798
upc019532720644
code_info
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2…All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ902540N, UPC Number: 019348991666. b. Model Number: DYNJ63257B, UPC Number: 019348942817. c. Model Number: DYNJ0771979C, UPC Number: 019348940069. d. Model Number: DYNJ906578F, UPC Number: 019532728963. e. Model Number: DYNJ906579F, UPC Number: 019532728964. f. Model Number: DYNJ906616G, UPC Number: 019532728947. g. Model Number: DYNJ905824I, UPC Number: 019532728972. h. Model Number: DYNJ906578D, UPC Number: 019532721712. i. Model Number: DYNJ906579A, UPC Number: 019348942214; Model Number: DYNJ906579B, UPC Number: 019348986153; Model Number: DYNJ906579D, UPC Number: 019532721713; Model Number: DYNJ906579F, UPC Number: 019532728964. j. Model Number: DYNJ906616A, UPC Number: 019348942213; Model Number: DYNJ906616B, UPC Number: 019348986167; Model Number: DYNJ906616C, UPC Number: 019532702358; Model Number: DYNJ906616D, UPC

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2333-2023%22

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