Recall archive / FDA device enforcement
Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT... — FDA record Z-1610-2025
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 Mar 3, 2025. 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 Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model Number: DYNJ53032C
- Reason
- There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Classification
- Class II
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Quantity
- 354 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1610-2025
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 | 1) DYNJ41856C, UDI-DI: 10195327429010(each), 40195327429011(case), Lot Number: 24JBM711; 2) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24JBN788; 3) DYNJ50629M, UDI-DI: 10198459146985(each), 40198459146986(case), Lot Number: 24JBW674; 4) DYNJ40040C, UDI-DI: 10889942683970(each), 40889942683971(case), Lot Number: 24KBC507; 5) DYNJ53032C, UDI-DI: 10195327494094(each), 40195327494095(case), Lot Number: 24KBC655 |
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, Mexico, Panama, Virgin Islands.
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
- Apr 23, 2025
- Recall initiation date
- Mar 3, 2025
- Center classification date
- Apr 17, 2025
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.