Z-2290-2023Class II

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL...

Name: Z-2290-2023 Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL...
Creator: MEDLINE INDUSTRIES, LP - Northfield
Published: 2023-05-15
License: https://open.fda.gov/license/

MEDLINE INDUSTRIES, LP - Northfield / initiated 2023-05-15 / Open, Classified / root cause: manufacturing process

FDA source

MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b... on 2023-05-15. FDA classified it as Class II and gives the reason as "Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2290-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-05-15
Posted: 2023-08-03
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Product: Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJE5900; b. COVER, PROBE, W/GEL AND BANDS, 6X24 - Model Number DYNJE5910; c. COVER, PROBE, W/GEL AND BANDS, 6X48 - Model Number DYNJE5920; d. COVER, PROBE, W/GEL AND BANDS, 6X96 - Model Number DYNJE5930; e. COVER, PROBE, W/GEL AND BANDS, 5X48 - Model Number DYNJE5940; f. COVER, PROBE, W/GEL AND BANDS, 4X48 - Model Number DYNJEX5900
Product code: MMP Cover, Barrier, Protective
Reason for recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.
Quantity in commerce: 1,231,480 kits
Distribution: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Product codes and lots: a. Model Number DYNJE5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010022, 06921020011, 06921020021, 06921030021, 06921030031, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011; b. Model Number DYNJE5910; UDI-DI Each: 10884389114094, Case: 40884389114095; Lot Numbers: 06920120011, 06920120011, 06921010011, 06921030011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921110011, 06921120011, 0692112H022, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692208H014; c. Model Number DYNJE5920; UDI-DI Each: 10884389114100, Case: 40884389114101; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920070011, 06920080012, 06920090011, 06920100011, 06920100011, 06920110011, 06920120011, 06920120011, 06920120012, 06921010011, 06921020021, 06921030012, 06921030021, 06921030021, 06921040011, 06921040011, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921100011, 06921100012, 06921100013, 06921110011, 0692112H022, 0692112H022, 0692112H022, 0692202H011, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H012, 0692205H013, 0692205H013, 0692206H011; d. Model Number DYNJE5930; UDI-DI Each: 10884389114117, Case: 40884389114118; Lot Numbers: 06920030012, 06920030021, 06920040022, 06920040022, 06920050011, 06920050011, 06920050011, 06920050012, 06920070011, 06920080012, 06920100011, 06920110011, 06920110011, 06920110011, 06920120011, 06920120011, 06921010011, 06921010011, 06921010011, 06921020021, 06921030021, 06921040011, 06921040011, 06921040011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 06921080011, 06921090011, 06921090011, 06921090012, 06921100011, 06921100012, 06921100012, 06921120011, 0692112H022, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692204H011, 0692204H011, 0692205H011, 0692205H011, 0692205H011, 0692205H011, 0692206H011; e. Model Number DYNJE5940; UDI-DI Each: 10888277723641, Case: 20888277723648; Lot numbers: 06920050011, 06920060012, 06920060012, 06920070021, 06920100011, 06920110011, 06920110011, 06920110011, 06920110012, 06920120011, 06921050011, 06921050011, 06921060011, 06921070011, 06921070011, 06921080011, 0692201H011, 0692202H011, 0692202H011, 0692202H024, 0692202H024, 0692203H011, 0692203H011, 0692204H011, 0692204H011; f. Model Number DYNJEX5900; UDI-DI Each: 10884389114124, Case: 40884389114125; Lot Numbers: 06920040022, 06920080012. **Lot format as follows: Example 069YYMM0001 where "069" is the last 3 digits of the vendor code for the probe cover kitting facility, "YYMM" is the year and month of manufacture of the probe cover kit, and "0001" is a sequential number for the month of production

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2290-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2291-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2292-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2293-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2294-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2295-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2296-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2297-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2298-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2299-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2300-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2301-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2302-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2303-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2304-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2305-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2306-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2307-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2308-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2309-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2310-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2311-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2312-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2313-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2314-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2315-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2316-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2317-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2318-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2319-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2320-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2321-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2322-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2323-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2324-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2325-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2326-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2327-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2328-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2329-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2330-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2331-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2332-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2333-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2334-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2335-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2336-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2337-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2338-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03
Z-2339-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-08-09	2023-08-03

Product code MMP

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)