Recall archive / FDA device enforcement
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) NERVE BLOCK ACCESSORY PACK, ... — FDA record Z-2158-2023
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) NERVE BLOCK ACCESSORY PACK, Model Number DYNJRA1220; b) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1773; c) PERI NEURO BLOCK PACK-LF, Model Number DYNJ51107B; d) PERI NEURO BLOCK PACK-LF, Model Number DYNJ0703127A; e) PERI NEURO BLOCK PACK-LF, Model Number DYNJ42367B; f) PERI NEURO BLOCK PACK-LF, Model Number DYNJRA1571; g) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJRA0656A; h) CVOR ANGIOGRAPHY PACK-LF, Model Number DYNJ47338; i) BLOCK KIT-LF, Model Number DYNJRA1287A; j) BLOCK KIT-LF, Model Number PAIN1622A; k) BLOCK KIT-LF, Model Number DYNJRA1543; l) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1635A; m) PK, RADIOLOGY-NEURO-IR, Model Number DYNJ0134147D; n) PK, RADIOLOGY-NEURO-IR, Model Number DYNJRA1604; o) BLOCK TRAY, Model Number PAIN1182;
- 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
- 23938 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2158-2023
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 DYNJRA1220, UDI/DI (EA)10888277795037, UDI/DI (CS)40888277795038; b) Model Number DYNJRA1773, UDI/DI (EA)10193489862973, UDI/DI (CS)40193489862974; c) Model Number DYNJ51107B, UDI/DI (EA)10193489810479, UDI/DI (CS)40193489810470; d) Model Number DYNJ0703127A, UDI/DI (EA)10889942084630, UDI/DI (CS)40889942084631; e) Model Number DYNJ42367B, UDI/DI (EA)10193489211511, UDI/DI (CS)40193489211512; f) Model Number DYNJRA1571, UDI/DI (EA)10193489264739, UDI/DI (CS)40193489264730; g) Model Number DYNJRA0656A, UDI/DI (EA)10889942225118, UDI/DI (CS)40889942225119; h) Model Number DYNJ47338, UDI/DI (EA)10888277900172, UDI/DI (CS)40888277900173; i) Model Number DYNJRA1287A, UDI/DI (EA)10193489773095, UDI/DI (CS)40193489773096; j) Model Number PAIN1622A, UDI/DI (EA)10193489891690, UDI/DI (CS)40193489891691; k) Model Number DYNJRA1543, UDI/DI (EA)10193489217667, UDI/DI (CS)40193489217668; l) Model Number DYNJRA1635A, UDI/DI (EA)10193489367645, UDI/DI (CS)40193489367646; m) Model Number DYNJ0134147D, UDI/DI (EA)10889942937349, UDI/DI (CS)40889942937340; n) Model Number DYNJRA1604, UDI/DI (EA)10193489299816, UDI/DI (CS)40193489299817; o) Model Number PAIN1182, UDI/DI (EA)10889942720927, UDI/DI (CS)40889942720928; |
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.