Medline Industries, LP recalls Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS

Recalling company

Medline Industries, LP

Product

Medline Convenience Kits: 1) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 2) BAP NORTH ROBOTIC SURGERY CDS, Model Number: CDS982407N; 3) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431J; 4) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431K; 5) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431L; 6) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431N; 7) TOT/ GYN LITHOTOMY CDS, Model Number: CDS985431O; 8) KIT ROBOTICS GYN, Model Number: DYKMBNDL109A; 9) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116A; 10) KIT ROBOTICS UROLOGY PROSTATE, Model Number: DYKMBNDL116G; 11) ROBOTIC PACK, Model Number: DYNJ04135B; 12) MINOR LITHOTOMY PACK, Model Number: DYNJ04382J; 13) NBMC D & C PACK-LF, Model Number: DYNJ0665843C; 14) D&C PACK-LF, Model Number: DYNJ22567G; 15) D&C PACK-LF, Model Number: DYNJ22567I; 16) D&C PACK-LF, Model Number: DYNJ22567J; 17) D&C PACK-LF, Model Number: DYNJ22567K; 18) D&C HYSTEROSCOPY PACK, Model Number: DYNJ38805B; 19) D AND C, Model Number: DYNJ41272B; 20) D AND C, Model Number: DYNJ41272C; 21) OB PACK, Model Number: DYNJ42884; 22) D&C/GYN PACK, Model Number: DYNJ47713A; 23) PERI GYN PACK, Model Number: DYNJ55377D; 24) ANTERIOR CERVICAL-LF, Model Number: DYNJ58344; 25) D&C PACK, Model Number: DYNJ67214D; 26) D&C PACK, Model Number: DYNJ67214F; 27) D&C PACK, Model Number: DYNJ67214G; 28) D&C PACK, Model Number: DYNJ67214I; 29) LITHOTOMY PACK, Model Number: DYNJ80765C; 30) GYN PACK, Model Number: DYNJ83475; 31) D AND C PACK, Model Number: DYNJ87468; 32) D&C-ASC, Model Number: DYNJ900465C; 33) D&C-ASC, Model Number: DYNJ900465D; 34) D&C-ASC, Model Number: DYNJ900465F; 35) GYN LITHOTOMY-LF, Model Number: DYNJ902711L; 36) GYN LITHOTOMY-LF, Model Number: DYNJ902711N; 37) D&C, Model Number: DYNJ906947C; 38) 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.

Classification

Class II – may cause temporary or medically reversible health consequences

Recall date

Jan 7, 2026

Reported

May 13, 2026

Distribution

Worldwide - US Nationwide distribution.

Status

Ongoing

Quantity

13376 units

Lot / codes

1) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21CBD150; 2) CDS982407N, UDI-DI: 10193489683004(each), 40193489683005(case), Lot Number: 21DBO201; 3) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23BBG608; 4) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23DBM469; 5) CDS985431J, UDI-DI: 10195327336110(each), 40195327336111(case), Lot Number: 23FBA948; 6) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBL932; 7) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23GBM332; 8) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23IBQ647; 9) CDS985431K, UDI-DI: 10195327451295(each), 40195327451296(case), Lot Number: 23JBF512; 10) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABA205; 11) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABV349; 12) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24ABW239; 13) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24CBR704; 14) CDS985431L, UDI-DI: 10195327527273(each), 40195327527274(case), Lot Number: 24EBP485; 15) CDS985431N, UDI-DI: 10198459081590(each), 40198459081591(case), Lot Number: 24JBG321; 16) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), Lot Number: 24LBH099; 17) CDS985431O, UDI-DI: 10198459195006(each), 40198459195007(case), L

Company location

Northfield, IL

Recall type

Voluntary: Firm initiated

Recall number

Z-2112-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2112-2026 in the FDA Enforcement Report. Also see FDA recall press releases.