Recall archive / FDA device enforcement
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) BREAST BIOPSY KIT, Model Num... — FDA record Z-2170-2023
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) BREAST BIOPSY KIT, Model Number DYNDA1224B; b) U/S CORE BIOPSY KIT, Model Number DYNDH1121C; c) BIOPSY PACK, Model Number DYNDH1124; d) REVAMP BIOPSY TRAY, Model Number DYNDH1147A; e) BREAST BIOPSY TRAY, Model Number DYNDH1266; f) BREAST BIOPSY TRAY, Model Number DYNDH1345A; g) ULTRASOUND BREAST BIOPSY, Model Number DYNDH1496A; h) BASIC BIOPSY TRAY, Model Number DYNDH1534; i) ULTRASOUND BIOPSY, Model Number DYNDH1542B; j) CABARRUS BIOPSY TRAY, Model Number DYNDH1670; k) BREAST BIOPSY TRAY, Model Number DYNDH1677; l) NORTH PARK BIOPSY TRAY, Model Number DYNDH1748; m) SOFT TISSUE BIOPSY, Model Number DYNDH1750; n) SOFT TISSUE BIOPSY, Model Number DYNDH1750A; o) UL BIOPSY TRAY, Model Number DYNDH1778; p) BREAST BIOPSY KIT, Model Number DYNDH1822; q) ULTRASOUND BIOPSY, Model Number DYNDH1828; r) BIOPSY PACK-LF, Model Number DYNJ0747885G; s) BIOPSY TRAY, Model Number DYNJ34637G; t) IGT BIOPSY PACK-LF, Model Number DYNJ38616A; u) BIOPSY WITH PROB COVER WRO-LF, Model Number DYNJ42307A; v) CORE BIOPSY PACK-LF, Model Number DYNJ42752A; w) BIOPSY TRAY, Model Number DYNJ43076; x) BIOPSY TRAY, Model Number DYNJ43076A; y) BIOPSY PACK, Model Number DYNJ50485; z) ABLATION/DRAINAGE PACK, Model Number DYNJ53658B; aa) BIOPSY RAD CT, Model Number DYNJ59752A; bb) US BREAST BIOPSY PACK, Model Number DYNJ61992B; cc) US BREAST BIOPSY PACK, Model Number DYNJ61992C; dd) BIOPSY TRAY, Model Number DYNJ62690; ee) IR BIOPSY PACK, Model Number DYNJ63688A; ff) IR BIOPSY PACK, Model Number DYNJ63688B; gg) IR BIOPSY PACK, Model Number DYNJ63688C; hh) IR BIOPSY PACK, Model Number DYNJ63688G; ii) IR BIOPSY PACK, Model Number DYNJ63688I; jj) INSERTION PACK, Model Number DYNJ83149; kk) GENERAL BIOPSY PACK, Model Number P365500; ll) RENAL BIOPSY TRAY, Model Number SPEC0168;
- 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
- 47185 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2170-2023
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 DYNDA1224B, UDI/DI (EA) 10193489468519, UDI/DI (CS) 40193489468510; b) Model Number DYNDH1121C, UDI/DI (EA) 10193489468656, UDI/DI (CS) 40193489468657; c) Model Number DYNDH1124, UDI/DI (EA) 10889942303274, UDI/DI (CS) 40889942303275; d) Model Number DYNDH1147A, UDI/DI (EA) 10193489348798, UDI/DI (CS) 40193489348799; e) Model Number DYNDH1266, UDI/DI (EA) 10889942670451, UDI/DI (CS) 40889942670452; f) Model Number DYNDH1345A, UDI/DI (EA) 10888277732933, UDI/DI (CS) 40888277732934; g) Model Number DYNDH1496A, UDI/DI (EA) 10193489825312, UDI/DI (CS) 40193489825313; h) Model Number DYNDH1534, UDI/DI (EA) 10193489197082, UDI/DI (CS) 40193489197083; i) Model Number DYNDH1542B, UDI/DI (EA) 10195327251475, UDI/DI (CS) 40195327251476; j) Model Number DYNDH1670, UDI/DI (EA) 10195327010683, UDI/DI (CS) 40195327010684; k) Model Number DYNDH1677, UDI/DI (EA) 10195327044480, UDI/DI (CS) 40195327044481; l) Model Number DYNDH1748, UDI/DI (EA) 10195327164744, UDI/DI (CS) 40195327164745; m) Model Number DYNDH1750, UDI/DI (EA) 10195327166427, UDI/DI (CS) 40195327166428; n) Model Number DYNDH1750A, UDI/DI (EA) 10195327337872, UDI/DI (CS) 40195327337873; o) Model Number DYNDH1778, UDI/DI (EA) 10195327228477, UDI/DI (CS) 40195327228478; p) Model Number DYNDH1822, UDI/DI (EA) 10195327292294, UDI/DI (CS) 40195327292295; q) Model Number DYNDH1828, UDI/DI (EA) 10195327311308, UDI/DI (CS) 40195327311309; r) Model Number DYNJ0747885G, UDI/DI (EA) 10195327088729, UDI/DI (CS) 40195327088720; s) Model Number DYNJ34637G, UDI/DI (EA) 10193489368802, UDI/DI (CS) 40193489368803; t) Model Number DYNJ38616A, UDI/DI (EA) 10884389755952, UDI/DI (CS) 40884389755953; u) Model Number DYNJ42307A, UDI/DI (EA) 10888277298750, UDI/DI (CS) 40888277298751; v) Model Number DYNJ42752A, UDI/DI (EA) 10889942326099, UDI/DI (CS) 40889942326090; w) Model Number DYNJ43076, UDI/DI (EA) 10888277024533, UDI/DI (CS) 40888277024534; x) Model Number DYNJ43076A, UDI/DI (EA) 10195327080624, UDI/DI (CS) 40195327080625; y) Model Number DYNJ50485, UDI/DI (EA) 10888277992795, UDI/DI (CS) 40888277992796; z) Model Number DYNJ53658B, UDI/DI (EA) 10195327088705, UDI/DI (CS) 40195327088706; aa) Model Number DYNJ59752A, UDI/DI (EA) 10193489598575, UDI/DI (CS) 40193489598576; bb) Model Number DYNJ61992B, UDI/DI (EA) 10195327292652, UDI/DI (CS) 40195327292653; cc) Model Number DYNJ61992C, UDI/DI (EA) 10195327406592, UDI/DI (CS) 40195327406593; dd) Model Number DYNJ62690, UDI/DI (EA) 10193489682267, UDI/DI (CS) 40193489682268; ee) Model Number DYNJ63688A, UDI/DI (EA) 10193489326451, UDI/DI (CS) 40193489326452; ff) Model Number DYNJ63688B, UDI/DI (EA) 10193489405590, UDI/DI (CS) 40193489405591; gg) Model Number DYNJ63688C, UDI/DI (EA) 10193489432282, UDI/DI (CS) 40193489432283; hh) Model Number DYNJ63688G, UDI/DI (EA) 10193489897197, UDI/DI (CS) 40193489897198; ii) Model Number DYNJ63688I, UDI/DI (EA) 10195327037239, UDI/DI (CS) 40195327037230; jj) Model Number DYNJ83149, UDI/DI (EA) 10195327235710, UDI/DI (CS) 40195327235711; kk) Model Number P365500, UDI/DI (EA) 10889942141852, UDI/DI (CS) 40889942141853; ll) Model Number SPEC0168, UDI/DI (EA) 10884389869864, UDI/DI (CS) 40884389869865; |
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.