Class IIOngoingZ-1421-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) SPINAL CDS

Medline Industries, LPNorthfield, IL, United StatesReported Feb 25, 2026 · 4 months ago

Legal News Analyst · Feb 25, 2026

Reason for recall

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.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

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 R, Model Number: DYKMBNDL141B; 62) KIT NEURO FUS LUM POST SANSUR, Model Number: DYKMBNDL142C; 63) KIT NEURO CRANIOTOMY ACOUSTIC, Model Number: DYKMBNDL143; 64) KIT NEURO CRANIOTOMY FOR TUMOR, Model Number: DYKMBNDL144; 65

Lot / code information

UDI: 10193489847260(each), 40193489847261(case)
Lot #: 21EBC900; 2) CDS940087AI
UDI: 10193489933758(each), 40193489933759(case)
Lot #: 22GBE442; 3) CDS940087AI
UDI: 10193489933758(each), 40193489933759(case)
Lot #: 22EBG548; 4) CDS940087AI
UDI: 10193489933758(each), 40193489933759(case)
Lot #: 22EBF695; 5) CDS940087AI
UDI: 10193489933758(each), 40193489933759(case)
Lot #: 22EBA274; 6) CDS940087AI

Additional code information

8(each), 40195327247769(case), Lot Number: 23LBA277; 360) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 23JBK019; 361) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 23IBA610; 362) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 23GBP488; 363) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 23FBI710; 364) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 22LBL868; 365) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 22KBD324; 366) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 22JBD221; 367) DYKMBNDL141A, UDI-DI: 10195327247768(each), 40195327247769(case), Lot Number: 22IBK345; 368) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25HBA792; 369) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25GBF719; 370) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25FBQ856; 371) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25EBR525; 372) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25DBI356; 373) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25CBI784; 374) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25BBS248; 375) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 25ABL332; 376) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 24JBF929; 377) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 24HBV609; 378) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 24HBG682; 379) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 24HBA088; 380) DYKMBNDL141B, UDI-DI: 10198459025921(each), 40198459025922(case), Lot Number: 24GBK949; 381) DYKMBNDL142C, UDI-DI: 10198459252969(each), 40198459252960(case), Lot Number: 25LBL432; 382) DYKMBNDL142C, UDI-DI: 10198459252969(each), 40198459252960(case), Lot Number: 25FBC129; 383) DYKMBNDL142C, UDI-DI: 10198459252969(each), 40198459252960(case), Lot Number: 25EBN171; 384) DYKMBNDL142C, UDI-DI: 10198459252969(each), 40198459252960(case), Lot Number: 25BBH467; 385) DYKMBNDL143, UDI-DI: 10193489482607(each), 40193489482608(case), Lot Number: 21CBT399; 386) DYKMBNDL143, UDI-DI: 10193489482607(each), 40193489482608(case), Lot Number: 21CBS017; 387) DYKMBNDL143, UDI-DI: 10193489482607(each), 40193489482608(case), Lot Number: 21BBN599; 388) DYKMBNDL143, UDI-DI: 10193489482607(each), 40193489482608(case), Lot Number: 21ABU298; 389) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22HLA742; 390) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22FLA327; 391) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22ELB110; 392) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22DLA896; 393) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22DLA727; 394) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22CLA771; 395) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 22BLA947; 396) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21LLA651; 397) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21LLA431; 398) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21KLB158; 399) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21JLA461; 400) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21ILA240; 401) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21HLA660; 402) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21HLA178; 403) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21GLA871; 404) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21GLA640; 405) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21FLA052; 406) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21DLA534; 407) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21DLA128; 408) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21CLA448; 409) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21CLA414; 410) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21CLA295; 411) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21CBH443; 412) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21BLA414; 413) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21ABU821; 414) DYKMBNDL144, UDI-DI: 10193489478358(each), 40193489478359(case), Lot Number: 21ABI784; 415) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 23GLA491; 416) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 23FLA815; 417) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 23DLA832; 418) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 23BLA654; 419) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 22LLA124; 420) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 22JLB035; 421) DYKMBNDL144A, UDI-DI: 10195327241032(each), 40195327241033(case), Lot Number: 22ILA386; 422) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25HLA637; 423) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25GLA271; 424) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25FLA991; 425) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25DLA246; 426) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25CLA509; 427) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 25ALA559; 428) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24LLA520; 429) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24KLA175; 430) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24ILA591; 431) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24HLA916; 432) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24GLA978; 433) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24FLA724; 434) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24DLA205; 435) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24ALB064; 436) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24ALA759; 437) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 24ALA066; 438) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 23JLB143; 439) DYKMBNDL144B, UDI-DI: 10195327481346(each), 40195327481347(case), Lot Number: 23HLA606; 440) DYKMBNDL145A, UDI-DI: 10193489846454(each), 40193489846455(case), Lot Number: 21DBK033; 441) DYKMBNDL145A, UDI-DI: 10193489846454(each), 40193489846455(case), Lot Number: 21CBF520; 442) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 23BLB013; 443) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 23BLA750; 444) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 23BLA145; 445) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22KLA317; 446) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22ILB139; 447) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22ILA954; 448) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22FLA364; 449) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22DLA064; 450) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22CLA549; 451) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 22BLB218; 452) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21LLA721; 453) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21KLA020; 454) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21JLA429; 455) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21JLA153; 456) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21ILA264; 457) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21HLA172; 458) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21GLB130; 459) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21GLB011; 460) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21ELA429; 461) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21DLA040; 462) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21CLA198; 463) DYKMBNDL146, UDI-DI: 10193489478372(each), 40193489478373(case), Lot Number: 21ALA530; 464) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22EBH424; 465) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22CBZ658; 466) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22BBR619; 467) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22BBA086; 468) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22BBA085; 469) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 22ABD080; 470) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 21JBM753; 471) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 21FBR384; 472) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 21EBK914; 473) DYKMBNDL162, UDI-DI: 10193489477375(each), 40193489477376(case), Lot Number: 21ABI979; 474) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23KBJ631; 475) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23HBY496; 476) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23HBN659; 477) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23HBH774; 478) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23HBH227; 479) DYKMBNDL162A, UDI-DI: 10195327240790(each), 40195327240791(case), Lot Number: 23ABV362; 480) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 22BBN302; 481) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 22BBA226; 482) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 21JBQ867; 483) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 21GBR322; 484) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 21CBM832; 485) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 21CBE515; 486) DYKMBNDL18, UDI-DI: 10193489478662(each), 40193489478663(case), Lot Number: 21ABL344; 487) DYKMBNDL181, UDI-DI: 10193489478471(each), 40193489478472(case), Lot Number: 22GBJ697; 488) DYKMBNDL181, UDI-DI: 10193489478471(each), 40193489478472(case), Lot Number: 21ABM598; 489) DYKMBNDL181, UDI-DI: 10 …

What the firm is doing

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,

DistributionShow details

Worldwide distribution - US Nationwide.

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus

Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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