FDA DevicesClass II
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B...
Published: February 25, 2026Recall ID: Z-1396-2026Category: devicesCountry: US
Reason for Recall / 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 & Identification
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Affected Products
Medline Convenience Kits: 1) BAPTIST FLOYD ENDO GI KIT, Model Number: DYKE1455B; 2) GI LAB OTHER ENDO KIT, Model Number: DYKE1721
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98329 |
| Address 1 | 3 Lakes Dr |
| Code info | 1) DYKE1455B, UDI-DI: 10193489760781(each), 40193489760782(case), Lot Number: 22IBV801; 2) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23KMC417; 3) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23IMF495; 4) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23HMG566; 5) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMF416; 6) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23GMC067; 7) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23EMF635; 8) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMG332; 9) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMC558; 10) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23CMB706; 11) DYKE1721, UDI-DI: 10193489258684(each), 40193489258685(case), Lot Number: 23BMC768; 12) DYKE1721, UDI-DI: 10193489258684(eac... [TRUNCATED] |
| Postal code | 60093-2753 |
| Report date | 20260225 |
| Product type | Devices |
| Product quantity | 23238 units |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260107 |
| Initial firm notification | Letter |
| Center classification date | 20260217 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide.