Recall archive / FDA device enforcement
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PAC... — FDA record Z-1616-2025
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) UTHET TYLER OB PACK, Model Number: DYNJ68673; 2) D AND C PACK, Model Number: DYNJ66290A; 3) D & C PACK-LF, Model Number: DYNJ24159C; 4) OB PACK, Model Number: DYNJ54484A; 5) PERI GYN-LF, Model Number: DYNJS3040; 6) D&C, Model Number: DYNJ900422F; 7) D&C HYSTEROSCOPY CDS, Model Number: CDS985201A; 8) D AND C PACK, Model Number: DYNJ66290A; 9) D&C PACK, Model Number: DYNJ47616B; 10) WMC D & C PACK-LF, Model Number: DYNJ50656B; 11) TRANSVAGINAL PACK, Model Number: DYNJ36599; 12) OB PACK, Model Number: DYNJ25915G; 13) PERI GYN-LF, Model Number: DYNJS3040; 14) MEMORIAL D AND C PACK, Model Number: DYNJ0989660A; 15) HYSTEROSCOPY PACK, Model Number: DYNJ64226A; 16) OB PACK, Model Number: DYNJ64571; 17) WMC D & C PACK-LF, Model Number: DYNJ50656B; 18) D & C PACK-LF, Model Number: DYNJT2535G; 19) OB PACK, Model Number: DYNJ44522B; 20) OB PACK-LF, Model Number: DYNJ26121G; 21) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 22) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 23) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C; 24) NYGH-HYSTEROSCOPY-LF, Model Number: DYNJ905534C
- 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
- 2,531 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1616-2025
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) DYNJ68673, UDI-DI: 10193489839951(each), 40193489839952(case), Lot Number: 24IBG873; 2) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24IBG957; 3) DYNJ24159C, UDI-DI: 10198459032394(each), 40198459032395(case), Lot Number: 24IBL229; 4) DYNJ54484A, UDI-DI: 10193489813074(each), 40193489813075(case), Lot Number: 24IBS805; 5) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBL655; 6) DYNJ900422F, UDI-DI: 10195327658373(each), 40195327658374(case), Lot Number: 24JBM234; 7) CDS985201A, UDI-DI: 10889942942312(each), 40889942942313(case), Lot Number: 24JBN479; 8) DYNJ66290A, UDI-DI: 10193489461428(each), 40193489461429(case), Lot Number: 24JBN645; 9) DYNJ47616B, UDI-DI: 10193489731040(each), 40193489731041(case), Lot Number: 24JBT461; 10) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24JBT906; 11) DYNJ36599, UDI-DI: 10884389554142(each), 40884389554143(case), Lot Number: 24JBW173; 12) DYNJ25915G, UDI-DI: 10193489718942(each), 40193489718943(case), Lot Number: 24JBW203; 13) DYNJS3040, UDI-DI: 10884389602225(each), 40884389602226(case), Lot Number: 24JBW545; 14) DYNJ0989660A, UDI-DI: 10889942136131(each), 40889942136132(case), Lot Number: 24JBX677; 15) DYNJ64226A, UDI-DI: 10195327135430(each), 40195327135431(case), Lot Number: 24KBC728; 16) DYNJ64571, UDI-DI: 10193489208986(each), 40193489208987(case), Lot Number: 24KBD692; 17) DYNJ50656B, UDI-DI: 10195327306410(each), 40195327306411(case), Lot Number: 24KBF096; 18) DYNJT2535G, UDI-DI: 10195327548506(each), 40195327548507(case), Lot Number: 24KBG398; 19) DYNJ44522B, UDI-DI: 10193489691511(each), 40193489691512(case), Lot Number: 24KBG967; 20) DYNJ26121G, UDI-DI: 10889942225248(each), 40889942225249(case), Lot Number: 24KBG978; 21) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24KBS436; 22) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBF208; 23) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 24LBR809; 24) DYNJ905534C, UDI-DI: 10193489247244(each), 40193489247245(case), Lot Number: 25ABF622 |
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.