Recall archive / FDA device enforcement
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model ... — FDA record Z-2169-2023
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 18, 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 sterile Ultrasound Gel, Labeled as the following: a) FETAL SURGERY CDS-LF, Model Number CDS840214Q; b) MINOR PROCEDURE TRAY, Model Number DYNDA2418; c) CLOSUREFAST PROCEDURE PACK-LF, Model Number DYNJ0365463J; d) BARIATRIC PACK, Model Number DYNJ24459P; e) ABLATION PACK, Model Number DYNJ40629B; f) ENDOLUMINAL ACCESSORY PACK, Model Number DYNJ44210B; g) IR THYROID PACK (THLUF)642-LF, Model Number DYNJ47716C; h) EVLT SURGICAL PACK, Model Number DYNJ48520; i) MAXIMAL BARRIER BEDSIDE PACK, Model Number DYNJ53059A; j) LAPAROSCOPY PACK, Model Number DYNJ59813; k) PORT PACK, Model Number DYNJ61747C; l) RR-BRACHY PACK, Model Number DYNJ68027A; m) AV FISTULA PACK, Model Number DYNJ81410B; n) ECMO PACK-LF, Model Number DYNJ82517; o) SYNERGY PROCEDURE PACK, Model Number DYNJ83966; p) MINOR, Model Number DYNJ906915; q) PROCEDURE PACK DR BILIMORI, Model Number DYNJ908046C; r) ULTRASOUND PACK-LF, Model Number PHS751646C; s) ULTRASOUND PACK-LF, Model Number PHS751646D;
- Reason
- Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 770147 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2169-2023
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 | all lots within expiry, distributed from Medline between December 2017 - May 2023: a) Model Number CDS840214Q, UDI/DI (EA) 10195327289904, UDI/DI (CS) 40195327289905; b) Model Number DYNDA2418, UDI/DI (EA) 10193489378214, UDI/DI (CS) 40193489378215; c) Model Number DYNJ0365463J, UDI/DI (EA) 10193489783872, UDI/DI (CS) 40193489783873; d) Model Number DYNJ24459P, UDI/DI (EA) 10193489355345, UDI/DI (CS) 40193489355346; e) Model Number DYNJ40629B, UDI/DI (EA) 10888277778696, UDI/DI (CS) 40888277778697; f) Model Number DYNJ44210B, UDI/DI (EA) 10193489306859, UDI/DI (CS) 40193489306850; g) Model Number DYNJ47716C, UDI/DI (EA) 10195327355296, UDI/DI (CS) 40195327355297; h) Model Number DYNJ48520, UDI/DI (EA) 10888277903463, UDI/DI (CS) 40888277903464; i) Model Number DYNJ53059A, UDI/DI (EA) 10889942415113, UDI/DI (CS) 40889942415114; j) Model Number DYNJ59813, UDI/DI (EA) 10888277786455, UDI/DI (CS) 40888277786456; k) Model Number DYNJ61747C, UDI/DI (EA) 10193489365030, UDI/DI (CS) 40193489365031; l) Model Number DYNJ68027A, UDI/DI (EA) 10195327351144, UDI/DI (CS) 40195327351145; m) Model Number DYNJ81410B, UDI/DI (EA) 10195327320829, UDI/DI (CS) 40195327320820; n) Model Number DYNJ82517, UDI/DI (EA) 10195327198640, UDI/DI (CS) 40195327198641; o) Model Number DYNJ83966, UDI/DI (EA) 10195327320423, UDI/DI (CS) 40195327320424; p) Model Number DYNJ906915, UDI/DI (EA) 10193489280371, UDI/DI (CS) 40193489280372; q) Model Number DYNJ908046C, UDI/DI (EA) 10195327313494, UDI/DI (CS) 40195327313495; r) Model Number PHS751646C, UDI/DI (EA) 10889942245352, UDI/DI (CS) 40889942245353; s) Model Number PHS751646D, UDI/DI (EA) 10195327196806, UDI/DI (CS) 40195327196807; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide Distribution: US (Nationwide) and OUS (foreign) United Arab Emirates, Singapore, Lebanon, China Qatar, Costa Rica, India, Canada, Panama & Saudi Arabia.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 26, 2023
- Recall initiation date
- May 18, 2023
- Center classification date
- Jul 20, 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.