FDA Device recall Z-1616-2025
Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673
- FDA Device
- Class II
- ongoing
- Published 2025-04-23
On 2025-04-23 the FDA classified a Class II recall of Medline Convenience kits used for various procedures: 1) UTHET TYLER OB PACK, Model Number: DYNJ68673 by Medline Industries Northfield, citing there is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1616-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-03 |
| Published | 2025-04-23 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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.
Identifiers
| code_info | 1) DYNJ68673, UDI-DI: 10193489839951(each), 40193489839952(case), Lot Number: 24IBG873; 2) DYNJ66290A, UDI-DI: 10193489…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-D |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1616-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.