FDA Device recall Z-1419-2026
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N
- FDA Device
- Class II
- ongoing
- Published 2026-02-25
On 2026-02-25 the FDA classified a Class II recall of Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N by Medline Industries, citing 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 packa….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1419-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-07 |
| Published | 2026-02-25 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Medline Industries |
| Distribution | US |
Product
Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 4) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 5) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 6) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 7) ROBOTIC PACK, Model Number: DYNJ04135B; 8) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 9) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 10) D&C PACK-LF, Model Number: DYNJ22567G; 11) D&C PACK-LF, Model Number: DYNJ22567J; 12) D AND C, Model Number: DYNJ41272B; 13) D AND C, Model Number: DYNJ41272C; 14) OB PACK, Model Number: DYNJ42884; 15) D&C/GYN PACK, Model Number: DYNJ47713A; 16) PERI GYN PACK, Model Number: DYNJ55377D; 17) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 18) D&C PACK, Model Number: DYNJ67214D; 19) D&C PACK, Model Number: DYNJ67214F; 20) D&C PACK, Model Number: DYNJ67214G; 21) D&C PACK, Model Number: DYNJ67214I; 22) LITHOTOMY PACK, Model Number: DYNJ80765C; 23) GYN PACK, Model Number: DYNJ83475; 24) D AND C PACK, Model Number: DYNJ87468; 25) D&C-ASC, Model Number: DYNJ900465C; 26) D&C-ASC, Model Number: DYNJ900465D; 27) D&C-ASC, Model Number: DYNJ900465F; 28) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 29) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 30) D&C, Model Number: DYNJ906947C; 31) PACK PERI GYN DSMC, Model Number: DYNJT6424
Reason
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.
Identifiers
| code_info | 1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 1019348…1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 3) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 4) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 5) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 25GBB847; 6) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21IBS290; 7) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21GBE967; 8) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21FBB105; 9) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21DBC065; 10) DYKMBNDL109A, UDI-DI: 10193489848779(each), 40193489848770(case), Lot Number: 21CBQ508; 11) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22HBE127; 12) DYK |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1419-2026%22
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