Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTA... — FDA record Z-1421-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 7, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
Medline Convenience Kits: 1) SPINAL CDS, Model Number: CDS940087AG; 2) SPINAL CDS, Model Number: CDS940087AI; 3) TOTAL HIP CDS-LF, Model Number: CDS980832Q; 4) TOTAL HIP CDS-LF, Model Number: CDS980832R; 5) TOTAL HIP CDS-LF, Model Number: CDS980832S; 6) TOTAL KNEE CDS-LF, Model Number: CDS980833Q; 7) TOTAL KNEE CDS-LF, Model Number: CDS980833R; 8) TOTAL HIP PROCEDURE, Model Number: CDS980865V; 9) TOTAL HIP PROCEDURE, Model Number: CDS980865W; 10) TOTAL HIP PROCEDURE, Model Number: CDS980865X; 11) TOTAL HIP PROCEDURE, Model Number: CDS980865Y; 12) TOTAL KNEE CDS, Model Number: CDS981454K; 13) TOTAL KNEE CDS, Model Number: CDS981454L; 14) KNEE ARTHROSCOPY CDS, Model Number: CDS981502K; 15) TOTAL KNEE, Model Number: CDS981505O; 16) TOTAL KNEE, Model Number: CDS981505P; 17) TOTAL KNEE, Model Number: CDS981505Q; 18) TOTAL KNEE, Model Number: CDS981505R; 19) OR LAMINECTOMY CDS, Model Number: CDS981858F; 20) LAMI FUSION, Model Number: CDS982035W; 21) ARMC TOTAL KNEE CDS, Model Number: CDS982281O; 22) ARMC TOTAL KNEE CDS, Model Number: CDS982281P; 23) ARMC TOTAL KNEE CDS, Model Number: CDS982281S; 24) TOTAL HIP CDS, Model Number: CDS983036K; 25) TOTAL KNEE CDS, Model Number: CDS983042K; 26) LOWER EXTREMITY CDS, Model Number: CDS983049K; 27) ZALE SPINE CDS, Model Number: CDS983182G; 28) TOTAL KNEE CDS, Model Number: CDS983297M; 29) SITTING CERVICAL CDS, Model Number: CDS983480G; 30) SHOULDER CDS, Model Number: CDS983581K; 31) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983838G; 32) TOTAL HIP CDS, Model Number: CDS983840I; 33) TOTAL JOINT CDS-LF, Model Number: CDS983863D; 34) SHOULDER ARTHROSCOPY CDS, Model Number: CDS983879C; 35) TOTAL JOINT, Model Number: CDS983903D; 36) GB TOTAL KNEE, Model Number: CDS984147K; 37) GB LOWER EXTREMITY, Model Number: CDS984156L; 38) LOWER EXTREMTIY, Model Number: CDS984254K; 39) LOWER EXTREMTIY, Model Number: CDS984254L; 40) LOWER EXTREMTIY, Model Number: CDS984254M; 41) LAMI MICRODISC-LF, Model Number: CDS984527I; 42) EXTREMITY CDS-LF, Model Number: CDS984607G; 43) EXTREMITY CDS-LF, Model Number: CDS984607I; 44) HANA/FRACTURE TABLE CDS-LF, Model Number: CDS984610C; 45) TOTAL JOINT CDS, Model Number: CDS985202B; 46) TOTAL JOINT CDS, Model Number: CDS985202C; 47) TRAUMA-LF, Model Number: CDS985279K; 48) ARTHROSCOPY CDS, Model Number: CDS985316A; 49) EXTREMITY CDS, Model Number: CDS985317C; 50) EXTREMITY CDS, Model Number: CDS985317D; 51) EXTREMITY CDS, Model Number: CDS985317F; 52) EXTREMITY CDS, Model Number: CDS985317G; 53) KNEE ARTHROSCOPY CDS, Model Number: CDS985425J; 54) TOTAL HIP PACK (CDSOPM834)-LF, Model Number: CDSOPM834W; 55) JOINT ASPIRATION KIT, Model Number: DYKM1161; 56) TOTAL KNEE SUPPLEMENT PACK NS, Model Number: DYKM2106; 57) KIT ORTHRO TOTAL HIP DR. NANDI, Model Number: DYKMBNDL137; 58) KIT NEUR FUS LUM POST CRANDALL, Model Number: DYKMBNDL138A; 59) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141; 60) KIT NEURO CRANIOTOMYANEURYSM R, Model Number: DYKMBNDL141A; 61) KIT NEURO CRANIOTOMYANEURYSM ...
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
Recalling firm
Medline Industries, LP
Quantity
117907 units
Agency-reported status
Ongoing
Source record identifier
Z-1421-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicability1) CDS940087AG, UDI-DI: 10193489847260(each), 40193489847261(case), Lot Number: 21EBC900; 2) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22GBE442; 3) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBG548; 4) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBF695; 5) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22EBA274; 6) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 22BBY060; 7) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21KBH163; 8) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21JBF936; 9) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21IBJ260; 10) CDS940087AI, UDI-DI: 10193489933758(each), 40193489933759(case), Lot Number: 21GBI183; 11) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21FBS254; 12) CDS980832Q, UDI-DI: 10193489788655(each), 40193489788656(case), Lot Number: 21BBL223; 13) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21LBO219; 14) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBQ650; 15) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21KBB625; 16) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBV695; 17) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21IBU197; 18) CDS980832R, UDI-DI: 10193489900972(each), 40193489900973(case), Lot Number: 21GBR895; 19) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23JBI054; 20) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23GBP400; 21) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23EBW653; 22) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23DBR887; 23) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23CBG614; 24) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBK758; 25) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 23BBJ844; 26) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBK666; 27) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22OBI093; 28) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22JBH355; 29) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22HBS531; 30) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBM598; 31) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBL549; 32) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK859; 33) CDS980832S, UDI-DI: 10195327064495(each), 40195327064496(case), Lot Number: 22GBK858; 34) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBL968; 35) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21LBC616; 36) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21KBF393; 37) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21JBO077; 38) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBV804; 39) CDS980833Q, UDI-DI: 10193489900989(each), 40193489900980(case), Lot Number: 21GBB808; 40) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23EBK295; 41) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23CBT556; 42) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23BBP326; 43) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABH483; 44) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 23ABG351; 45) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22IBE748; 46) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS173; 47) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22GBS172; 48) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22FBD583; 49) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 22DBN516; 50) CDS980833R, UDI-DI: 10195327064501(each), 40195327064502(case), Lot Number: 21LBW480; 51) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21FBH003; 52) CDS980865V, UDI-DI: 10193489304206(each), 40193489304207(case), Lot Number: 21ABX303; 53) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22OBL581; 54) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22IMH323; 55) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22GBM603; 56) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22FBO257; 57) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 22DBD515; 58) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21VBC540; 59) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA989; 60) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21JBA988; 61) CDS980865W, UDI-DI: 10193489929157(each), 40193489929158(case), Lot Number: 21IBP619; 62) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23FMI799; 63) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23EME858; 64) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMF336; 65) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23DMB940; 66) CDS980865X, UDI-DI: 10195327243135(each), 40195327243136(case), Lot Number: 23CMA547; 67) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24IMH073; 68) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24HMH806; 69) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24FMG472; 70) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24EMC301; 71) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24CMC328; 72) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 24AMG267; 73) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23KMH550; 74) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23IMA365; 75) CDS980865Y, UDI-DI: 10195327446529(each), 40195327446520(case), Lot Number: 23HMF744; 76) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24DMH818; 77) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24CMC092; 78) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24BMF152; 79) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 24AMB397; 80) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23FME101; 81) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23EMG643; 82) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23DMH779; 83) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMF017; 84) CDS981454K, UDI-DI: 10195327310455(each), 40195327310456(case), Lot Number: 23CMB403; 85) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25BMJ035; 86) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 25AMJ535; 87) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24LMC844; 88) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24KMB678; 89) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24JMB660; 90) CDS981454L, UDI-DI: 10195327689445(each), 40195327689446(case), Lot Number: 24GMI703; 91) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 24CMF795; 92) CDS981502K, UDI-DI: 10195327295370(each), 40195327295371(case), Lot Number: 23JMI916; 93) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22KBM385; 94) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22JBK515; 95) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22IBJ349; 96) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBQ624; 97) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22HBN671; 98) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22FBS293; 99) CDS981505O, UDI-DI: 10195327071202(each), 40195327071203(case), Lot Number: 22ABS105; 100) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24BBH054; 101) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 24ABU182; 102) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ766; 103) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23KBQ737; 104) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23GBG193; 105) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23DBL133; 106) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBU775; 107) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23CBI326; 108) CDS981505P, UDI-DI: 10195327286231(each), 40195327286232(case), Lot Number: 23ABG957; 109) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24IBD132; 110) CDS981505Q, UDI-DI: 10198459028991(each), 40198459028992(case), Lot Number: 24GBJ138; 111) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25DBO814; 112) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 25BBD996; 113) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24LBR473; 114) CDS981505R, UDI-DI: 10198459177361(each), 40198459177362(case), Lot Number: 24KBP956; 115) CDS981858F, UDI-DI: 10889942973682(each), 40889942973683(case), Lot Number: 21ABH636; 116) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22HBP524; 117) CDS982035W, UDI-DI: 10193489999259(each), 40193489999250(case), Lot Number: 22GBI202; 118) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 23AMB059; 119) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22LMB455; 120) CDS982281O, UDI-DI: 10888277787223(each), 40888277787224(case), Lot Number: 22CME430; 121) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 25BMC093; 122) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24FMA426; 123) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24EMD974; 124) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24CMB637; 125) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 24AMD955; 126) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23IMF292; 127) CDS982281P, UDI-DI: 10195327472801(each), 40195327472802(case), Lot Number: 23HME111; 128) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LME952; 129) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25LMD470; 130) CDS982281S, UDI-DI: 10198459561238(each), 40198459561239(case), Lot Number: 25KMJ877; 131) CDS983036K, UDI-DI: 10193489842012(each), 40193489842013(case), Lot Number: 23KBN289; 132) CDS983042K, UDI-DI: 10193489842029(each), 40193489842020(case), Lot Number: 23KBN273; 133) CDS983049K, UDI-DI: 10193489841657(each), 40193489841658(case), Lot Number: 23...

The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Worldwide distribution - US Nationwide.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Feb 25, 2026
Recall initiation date
Jan 7, 2026
Center classification date
Feb 17, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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