CLASS II ONGOING Device recall · Reported 9 Aug 2023 · FDA Enforcement Report
Medline Probe Cover Kits containing Turkuaz Ultrasound Gel recalled
Medline Industries LP - Northfield is recalling Medline Probe Cover Kits containing Turkuaz Ultrasound Gel, Labeled as the following: a, 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
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-2290-2023
- 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
- Device type
- Imaging Equipment
Timeline
| 15 May 2023 | Recall initiated by company | |
| 3 Aug 2023 | Classified by FDA | +80 days |
| 9 Aug 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
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
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
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.
Questions about this recall
Why was it recalled?
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Which lots are affected?
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
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
49 other products · FDA event 92399This product is part of a recall event; the main page for the event is Custom Sterile and Non-Sterile Procedural Kits recalled.
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