Recall archive / FDA device enforcement
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
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 1) 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.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
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.