CLASS II ONGOING Device recall · Reported 26 Jul 2023 · FDA Enforcement Report

Medline Probe Cover Kits recalled by MEDLINE INDUSTRIES, LP

MEDLINE INDUSTRIES, LP - Northfield is recalling Medline Probe Cover Kits, distributed nationwide in the US. The recall was initiated on 18 May 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots within expiry, distributed from Medline between December 2017 May 2023: Model Number (GTIN Number): DYNJE5900 (Each: 10884389114124, Case: 40884389114125), DYNJE5910 (Each: 10884389114094, Case: 40884389114095), DYNJE5920 (Each: 10884389114100, Case: 40884389114101), DYNJE5930 (Each: 10884389114117, Case: 40884389114118), DYNJE5940 (Each: 10888277723641, Case: 20888277723648), DYNJEX5900 (Each: 10884389114124, Case: 40884389114125). All lots within their expiration date.

Quantity recalled1,505,262 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-2154-2023
FDA event ID: 92466
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL
Classification: Class II
Status: Ongoing
Recall initiated: 18 May 2023
FDA classified: 20 Jul 2023
Reported: 26 Jul 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Imaging Equipment

Timeline

18 May 2023	Recall initiated by company
20 Jul 2023	Classified by FDA	+63 days
26 Jul 2023	Published 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

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

Product as listed by the FDA

Medline Probe Cover Kits, Model Numbers: DYNJE5900, DYNJE5910, DYNJE5920, DYNJE5930, DYNJE5940, DYNJEX5900. for use during diagnostic ultrasound procedures

Where it was distributed

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

Nationwide

Stores named: Walmart

Questions about this recall

Is Medline Probe Cover Kits recalled?

Yes. MEDLINE INDUSTRIES, LP - Northfield recalled Medline Probe Cover Kits on 18 May 2023. The recall is Class II and its status is Ongoing. Recall number Z-2154-2023.

Why was it recalled?

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

Which lots are affected?

All lots within expiry, distributed from Medline between December 2017 May 2023: Model Number (GTIN Number): DYNJE5900 (Each: 10884389114124, Case: 40884389114125), DYNJE5910 (Each: 10884389114094, Case: 40884389114095), DYNJE5920 (Each: 10884389114100, Case: 40884389114101), DYNJE5930 (Each: 10884389114117, Case: 40884389114118), DYNJE5940 (Each: 10888277723641, Case: 20888277723648), DYNJEX5900 (Each: 10884389114124, Case: 40884389114125). All lots within their expiration date.

Where was it sold?

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

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.

More recalls from MEDLINE INDUSTRIES, LP - Northfield

All 792

Reported	Class	Recall	Company	Reason	Where
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
1 Oct 2025Device	CLASS I	Medline medical convenience kits labeled as recalled	MEDLINE INDUSTRIES, LP - Northfield	Device Malfunction	6 states
3 Sep 2025Device	CLASS I	Medline ReNewal Reprocessed St. Jude Medical Response recalled	MEDLINE INDUSTRIES, LP - Northfield	Particulate Matter	Nationwide
3 Sep 2025Device	CLASS II	The Medline General Surgery Tray is customized to meet recalled	MEDLINE INDUSTRIES, LP - Northfield	Sterility	Nationwide
3 Sep 2025Device	CLASS II	Medline Kits containing BD SureStep Foley Tray Systems recalled	MEDLINE INDUSTRIES, LP - Northfield	Labeling Errors	FL, IL

Other Imaging Equipment recalls

All 2,336

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Lead & Heavy Metals	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits: Ultrasound Breast Pack recalled	Medline Industries	Sterility	Nationwide
2 Sep 2026Device	CLASS II	Alphenix Models Infx-8000C Infx-8000F Infx-8000V This device is recalled	Canon Medical System, USA	Other	Nationwide
2 Sep 2026Device	CLASS II	Merge PACS and Merge OrthoPACS recalled by Merge Healthcare	Merge Healthcare	Labeling Errors	Nationwide
19 Aug 2026Device	CLASS II	Philips Azurion recalled by Philips Medical Systems	Philips Medical Systems Nederland B.v	Lead & Heavy Metals