Recall archive / FDA device enforcement

Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a. COVER, PROBE, W/GEL AND BAND... — FDA record Z-2290-2023

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 15, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

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
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Classification: Class II
Recalling firm: MEDLINE INDUSTRIES, LP - Northfield
Quantity: 1,231,480 kits
Agency-reported status: Ongoing
Source record identifier: Z-2290-2023

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	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

Label field

Details supplied by the agency

Lot, code or applicability

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

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Aug 9, 2023
Recall initiation date: May 15, 2023
Center classification date: Aug 3, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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