Medline Industries, LP: 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

Recall number

Z-1419-2026

Recalling firm

Medline Industries, LP

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

Status

Open, Classified

Initiated

2026-01-07

Posted

2026-02-17

Terminated

not on file

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.

Root cause

Under Investigation by firm

Action

An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Proxima Sterile Surgical Gowns, Packs, and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. Upon completion of the below actions, please destroy affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. Website link: https://recalls.medline.com Recall Reference #: R-26-003 Recall Code: 3. Your account will receive credit once the response form is submitted. 4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers destroy any affected product. You should include your customers quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. An URGENT MEDICAL DEVICE RECALL notification letter dated 1/7/26 was sent to customers regarding Medline Kits containing Proxima Sterile Surgical Gowns and Drapes. REQUIRED ACTION: 1. Immediately check your stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product. 2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the form. Website link: https://recalls.medline.com Recall Reference #: R-26-003-FGX1 Recall Code: 3. Upon receipt of your submitted response form,

Quantity

7725 units

Distribution

Worldwide distribution - US Nationwide.

Lot, serial or model codes

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) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22GBL821; 13) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBM235; 14) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22FBC878; 15) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP063; 16) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 22EBP060; 17) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21KBQ697; 18) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21HBB549; 19) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21FBB101; 20) DYKMBNDL116A, UDI-DI: 10193489880717(each), 40193489880718(case), Lot Number: 21DBE919; 21) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25GBG086; 22) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25EBM426; 23) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25BBI842; 24) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 25ABF361; 25) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBH410; 26) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24LBE008; 27) DYKMBNDL116G, UDI-DI: 10198459156991(each), 40198459156992(case), Lot Number: 24KBD429; 28) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23KBH005; 29) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 23CBK988; 30) DYNJ04135B, UDI-DI: 10888277893535(each), 40888277893536(case), Lot Number: 20XBF598; 31) DYNJ04382J, UDI-DI: 10195327271763(each), 40195327271764(case), Lot Number: 22JMI206; 32) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23LBR468; 33) DYNJ0665843C, UDI-DI: 10195327461041(each), 40195327461042(case), Lot Number: 23JBL141; 34) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21DBJ206; 35) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABL629; 36) DYNJ22567G, UDI-DI: 10193489267877(each), 40193489267878(case), Lot Number: 21ABK140; 37) DYNJ22567J, UDI-DI: 10195327524876(each), 40195327524877(case), Lot Number: 24FBJ094; 38) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23GMF146; 39) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23EME955; 40) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG245; 41) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 23AMG044; 42) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22GME486; 43) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22DMD888; 44) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 22AME935; 45) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21LMB348; 46) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21IMB245; 47) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21GMF389; 48) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21FMA773; 49) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21DME541; 50) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21BMB150; 51) DYNJ41272B, UDI-DI: 10193489792027(each), 40193489792028(case), Lot Number: 21AMA560; 52) DYNJ41272C, UDI-DI: 10195327487409(each), 40195327487400(case), Lot Number: 23IMA347; 53) DYNJ42884, UDI-DI: 10888277011076(each), 40888277011077(case), Lot Number: 23CBJ945; 54) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24GBW285; 55) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24FBB582; 56) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 24DBG903; 57) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23IBQ206; 58) DYNJ47713A, UDI-DI: 10193489648850(each), 40193489648851(case), Lot Number: 23GBP395; 59) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBV760; 60) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23FBQ343; 61) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23EBB329; 62) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23DBC104; 63) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23CBB298; 64) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 23ABU921; 65) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22KBF536; 66) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22JBM589; 67) DYNJ55377D, UDI-DI: 10195327138073(each), 40195327138074(case), Lot Number: 22DBQ586; 68) DYNJ58344, UDI-DI: 10889942841721(each), 40889942841722(case), Lot Number: 21DBG514; 69) DYNJ67214D, UDI-DI: 10195327133320(each), 40195327133321(case), Lot Number: 22JBM637; 70) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23CBS078; 71) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 23BBM551; 72) DYNJ67214F, UDI-DI: 10195327277802(each), 40195327277803(case), Lot Number: 22LBT250; 73) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23LBG081; 74) DYNJ67214G, UDI-DI: 10195327411305(each), 40195327411306(case), Lot Number: 23GBI555; 75) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24DBB420; 76) DYNJ67214I, UDI-DI: 10195327586959(each), 40195327586950(case), Lot Number: 24ABG486; 77) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25LBI656; 78) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25KBT912; 79) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBL938; 80) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25IBC889; 81) DYNJ80765C, UDI-DI: 10198459367106(each), 40198459367107(case), Lot Number: 25GBO543; 82) DYNJ83475, UDI-DI: 10195327268411(each), 40195327268412(case), Lot Number: 23GBA918; 83) DYNJ87468, UDI-DI: 10198459041266(each), 40198459041267(case), Lot Number: 24HBC480; 84) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23FMD008; 85) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DME071; 86) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23DMC062; 87) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 23AMJ541; 88) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22JMF456; 89) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMC505; 90) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22IMA128; 91) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22GBP729; 92) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBG597; 93) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22EBD247; 94) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 22BBE872; 95) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21JBW028; 96) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBI550; 97) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21IBA045; 98) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21HBK281; 99) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21FBL088; 100) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21DBC055; 101) DYNJ900465C, UDI-DI: 10889942932238(each), 40889942932239(case), Lot Number: 21ABU698; 102) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24EMG501; 103) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24CME409; 104) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 24AMA976; 105) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23KMA629; 106) DYNJ900465D, UDI-DI: 10195327422936(each), 40195327422937(case), Lot Number: 23JMD404; 107) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25LMA690; 108) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25IMG392; 109) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 25BMF779; 110) DYNJ900465F, UDI-DI: 10198459121746(each), 40198459121747(case), Lot Number: 24IMI010; 111) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24LBF949; 112) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24KBT705; 113) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24JBH803; 114) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24HBU990; 115) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24GBW026; 116) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24EBJ699; 117) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24DBI465; 118) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24CBT820; 119) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBG800; 120) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24BBC557; 121) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 24ABG736; 122) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23LBP758; 123) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBN910; 124) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23KBH145; 125) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23IBA468; 126) DYNJ902711L, UDI-DI: 10195327468064(each), 40195327468065(case), Lot Number: 23HBI647; 127) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25LMF580; 128) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25JBO532; 129) DYNJ902711N, UDI-DI: 10198459452154(each), 40198459452155(case), Lot Number: 25IBD839; 130) DYNJ906947C, UDI-DI: 10195327569006(each), 40195327569007(case), Lot Number: 24BBL769; 131) DYNJT6424, UDI-DI: 10198459553622(each), 40198459553623(case), Lot Number: 25KMI469

510(k) numbers

not on file

PMA numbers

not on file

Product code

OKV

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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