CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report

Custom Sterile and Non-Sterile Procedural Kits recalled

MEDLINE INDUSTRIES, LP - Northfield is recalling Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel, distributed nationwide in the US. The recall was initiated on 15 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll 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.
Quantity recalled6,340 kits

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number
Z-2335-2023
FDA event ID
92399
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification
Class II
Status
Ongoing
Recall initiated
15 May 2023
FDA classified
3 Aug 2023
Reported
9 Aug 2023
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Sterility

Timeline

15 May 2023Recall initiated by company
3 Aug 2023Classified by FDA+80 days
9 Aug 2023Published in enforcement report+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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;

Where it was distributed

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

Nationwide

Questions about this recall

Is Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel on 15 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2335-2023.

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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