Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 07, 2026 |
| Reported | February 25, 2026 |
| Recalling firm | Medline Industries, LP |
| Country / region | United States IL |
Hazard
Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.
Product description
Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807J; 4) VAGINAL HYSTERECTOMY PACK-LF, Model Number: DYNJ0373807K; 5) MINOR VAGINAL #76-RF, Model Number: DYNJ27434R; 6) VAG HYST PACK, Model Number: DYNJ31344J; 7) VAG HYST PACK, Model Number: DYNJ31344K; 8) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393L; 9) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393M; 10) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393N; 11) RRMC VAGINAL HYSTERECTOMY PACK, Model Number: DYNJ33393O; 12) LAVH PACK, Model Number: DYNJ36712F; 13) D&C MINOR LITHOTOMY PACK, Model Number: DYNJ45090I; 14) D C HYSTEROSCOPY PACK-LF, Model Number: DYNJ45801C; 15) VAG HYST PACK (VHGSG)642-LF, Model Number: DYNJ47694I; 16) HYSTEROSCOPY D AND C PACK, Model Number: DYNJ51741B; 17) LAVH - N #668629 -N, Model Number: DYNJ58121C; 18) PK, GYN-MINOR-LITHO, Model Number: DYNJ59037B; 19) HYSTEROSCOPY PACK, Model Number: DYNJ59444G; 20) D AND C PACK, Model Number: DYNJ61282B; 21) VAGINAL HYSTERECTOMY, Model Number: DYNJ67161; 22) PERI GYN, Model Number: DYNJ67708A; 23) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713B; 24) ROBOTIC HYSTERECTOMY PACK, Model Number: DYNJ69713C; 25) ANORECTAL PACK, Model Number: DYNJ83560; 26) D&C CDS, Model Number: DYNJ902560I; 27) HYSTEROSCOPY, Model Number: DYNJ903327K; 28) ROBOTIC HYST, Model Number: DYNJ903798G; 29) TLH KIT, Model Number: DYNJ908149; 30) LAVH TOTE, Model Number: DYNJ908340; 31) LAVH TOTE, Model Number: DYNJ908340A; 32) LAVH TOTE, Model Number: DYNJ908340B; 33) LAVH TOTE, Model Number: DYNJ908340D; 34) BRECKENRIDGE LAVH, Model Number: DYNJ910537; 35) VAG HYST PACK, Model Number: DYNJT3348; 36) LAVH PART B, Model Number: DYNJV0312G
Affected products
- Medline Convenience Kits: 1) HYSTEROSCOPY, Model Number: CDS984086I; 2) KIT GYN ONCOLOGY LAP, Model Number: DYKMBNDL91A; 3) VAGINAL HYSTERECTOMY PACK-LF, M