Class IIOngoingZ-1390-2026

Medline Industries, LP recalls Medline Convenience Kits: 1) OPEN HEART 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) OPEN HEART CDS, Model Number: CDS840015AQ; 2) OPEN HEART CDS, Model Number: CDS840023T; 3) OFF PUMP CABG CDS, Model Number: CDS840087AI; 4) OFF PUMP CABG CDS, Model Number: CDS840087AK; 5) OFF PUMP CABG CDS, Model Number: CDS840087AL; 6) OPEN HEART, Model Number: CDS840150S; 7) OPEN HEART, Model Number: CDS840150T; 8) OPEN HEART, Model Number: CDS840150U; 9) OPEN HEART, Model Number: CDS840150V; 10) OPEN HEART, Model Number: CDS840150W; 11) UNIVERSAL HEART CDS, Model Number: CDS840246O; 12) GENERAL AAA #11-RF, Model Number: CDS840261AB; 13) OPEN HEART ADULT, Model Number: CDS840396AA; 14) OPEN HEART ADULT, Model Number: CDS840396AB; 15) OPEN HEART ADULT, Model Number: CDS840396X; 16) OPEN HEART ADULT, Model Number: CDS840396Y; 17) OPEN HEART CDS, Model Number: CDS840428K; 18) OPEN HEART CDS, Model Number: CDS840428L; 19) PACEMAKER CDS, Model Number: CDS980839C; 20) KIT, CVC ADD A PACK HUM-LF, Model Number: CDS982564C; 21) OPEN HEART ADULT HUM, Model Number: CDS982566K; 22) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575K; 23) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575M; 24) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575O; 25) OPEN HEART BOX 1 CDS MRH, Model Number: CDS982575P; 26) OPEN HEART, Model Number: CDS983348S; 27) HEART CABG CDS, Model Number: CDS983376Q; 28) HEART CABG CDS, Model Number: CDS983376T; 29) HEART CABG CDS, Model Number: CDS983376U; 30) HEART CABG CDS, Model Number: CDS983376V; 31) OPEN HEART CDS, Model Number: CDS983513F; 32) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786D; 33) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786F; 34) OPEN HEART ADULT PART 2 CDS, Model Number: CDS983786G; 35) PEDS CARDIAC CDS, Model Number: CDS984117F; 36) OPEN HEART CDS, Model Number: CDS984276P; 37) OPEN HEART ACCESSORY CDS, Model Number: CDS984289J; 38) OPEN HEART ACCESSORY CDS, Model Number: CDS984289K; 39) OPEN HEART ACCESSORY CDS, Model Number: CDS984289L; 40) OPEN HEART ACCESSORY CDS, Model Number: CDS984289M; 41) OPEN HEART ACCESSORY CDS, Model Number: CDS984289N; 42) OPEN HEART ACCESSORY CDS, Model Number: CDS984289O; 43) OPEN HEART CDS, Model Number: CDS984355F; 44) OPEN HEART CDS, Model Number: CDS984355G; 45) OPEN HEART CDS, Model Number: CDS984355I; 46) OPEN HEART CDS, Model Number: CDS984355J; 47) OPEN HEART A, Model Number: CDS985105M; 48) OPEN HEART A, Model Number: CDS985105N; 49) OPEN HEART A, Model Number: CDS985105O; 50) VASCULAR CDS, Model Number: CDS985215C; 51) BASE HEART PACK-LF, Model Number: CVT159AA; 52) ENDO KIT, Model Number: DYKE1580B; 53) KIT VASCULAR MINOR, Model Number: DYKMBNDL11; 54) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118; 55) KIT VASCULAR CAROTID, Model Number: DYKMBNDL118A; 56) KIT VASCULAR BYPASS GRAFT GENE, Model Number: DYKMBNDL120; 57) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14; 58) KIT VASCULAR PERCUTANEOUS TEVA, Model Number: DYKMBNDL14A; 59) KIT VASCULAR VNS, Model Number: DYKMBNDL152; 60) KIT VASCULAR VNS, Model Number: DYKMBNDL152A; 61) KIT THORACIC SYMPHATECTOMY, Model Number: DYKMBNDL187; 62) KIT UROLOGY PERIPHERAL STIMULA, Model Number: DYKMBNDL189B; 63) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL191; 64) KIT VASCULAR ANGIOGRAM GENERIC, Model Number: DYKMBNDL192; 65) KIT VASCULAR ENDOVENOUS ABLATI, Model Number: DYKMBNDL203; 66) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209A; 67) KIT VASCULAR MEDIAN ARCUATE, Model Number: DYKMBNDL209B; 68) CARDIAC ADULT CABG, Model Number: DYKMBNDL20A; 69) CARDIAC ADULT CABG, Model Number: DYKMBNDL20B; 70) KIT CARDIAC CSICU ADULT ECMO, Model Number: DYKMBNDL21; 71) KIT VASCULAR AAA REPAIR, Model Number: DYKMBNDL23A; 72) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27A; 73) KIT CARDIAC ANEURYSM, Model Number: DYKMBNDL27B; 74) KIT PEDS CARDIAC ADULT, Model Number: DYKMBNDL4

Lot / code information

UDI: 10195327210144(each), 40195327210145(case)
Lot #: 23FLA191; 2) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 23LBM199; 3) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 23KBM369; 4) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 23JBU616; 5) CDS840023T
UDI: 10193489682069(each), 40193489682060(case)
Lot #: 23IBJ759; 6) CDS840023T

Additional code information

118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21GLA161; 361) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21FLA215; 362) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21DLA456; 363) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21BLA306; 364) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21BBF731; 365) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 21ABL157; 366) DYKMBNDL118, UDI-DI: 10193489479300(each), 40193489479301(case), Lot Number: 20XBA425; 367) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25LLA510; 368) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25ILA365; 369) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25HLA331; 370) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25GLA109; 371) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25CLA313; 372) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 25BLA585; 373) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24KLB057; 374) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24HLA380; 375) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 24CLA833; 376) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23LLA174; 377) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23KLA391; 378) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ILA666; 379) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23FLA324; 380) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ELA941; 381) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ELA838; 382) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23DLA355; 383) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23CLA705; 384) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23BLA828; 385) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 23ALA566; 386) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22KLA582; 387) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22ILB112; 388) DYKMBNDL118A, UDI-DI: 10195327240677(each), 40195327240678(case), Lot Number: 22ILA065; 389) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25LLA349; 390) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25JLB053; 391) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25GLA494; 392) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25FLA240; 393) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25DLA352; 394) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25BLA990; 395) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25BLA424; 396) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 25ALB013; 397) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24LLA579; 398) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24KLA949; 399) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24GLA056; 400) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24ELA331; 401) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24ELA077; 402) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24CLA597; 403) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24BLA044; 404) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 24ALB056; 405) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23LLA448; 406) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23KLA994; 407) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23HLB003; 408) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23GLA840; 409) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23FLA967; 410) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23ELA675; 411) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23ELA040; 412) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23DLA682; 413) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23CLA186; 414) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 23BLA245; 415) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22LLA597; 416) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22LLA146; 417) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22JLB091; 418) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22HLB104; 419) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22GLB229; 420) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22GLA229; 421) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22ELB071; 422) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22DLA164; 423) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 22CBD042; 424) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA903; 425) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA708; 426) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21LLA186; 427) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21JLA983; 428) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21JLA460; 429) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ILA312; 430) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21HLB003; 431) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21GLB132; 432) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21FLA945; 433) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21FLA091; 434) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ELA354; 435) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21CLA211; 436) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21BLA317; 437) DYKMBNDL120, UDI-DI: 10193489478082(each), 40193489478083(case), Lot Number: 21ABJ093; 438) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23LBP163; 439) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23LBC712; 440) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23JBY285; 441) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23IBG420; 442) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23HBO526; 443) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23HBC121; 444) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23FBQ222; 445) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23EBP454; 446) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23CBP836; 447) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 23BBP965; 448) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22LBK907; 449) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22JBK931; 450) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22JBD609; 451) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22IBC491; 452) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22HBH510; 453) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22HBB974; 454) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22GBS119; 455) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22DBR013; 456) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22DBP495; 457) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22DBL096; 458) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22CBS524; 459) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22BBL863; 460) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 22ABB464; 461) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 21JBD210; 462) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 21HBC607; 463) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 21FBB100; 464) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 21BBG053; 465) DYKMBNDL14, UDI-DI: 10193489478631(each), 40193489478632(case), Lot Number: 21ABN769; 466) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25LBN111; 467) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25GBP609; 468) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25EBN099; 469) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25DBI894; 470) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25DBI893; 471) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25CBR584; 472) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 25ABE334; 473) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24LBC933; 474) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24JBY394; 475) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24HBC859; 476) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24GBQ246; 477) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24EBR754; 478) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24DBR729; 479) DYKMBNDL14A, UDI-DI: 10195327628840(each), 40195327628841(case), Lot Number: 24DBB197; 480) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 23JBT153; 481) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 23FBM174; 482) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 23FBJ607; 483) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 23ABF139; 484) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 22FBI463; 485) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 22FBC067; 486) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 22EBP246; 487) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 21LBY227; 488) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 21HBL119; 489) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478434(case), Lot Number: 21FBQ540; 490) DYKMBNDL152, UDI-DI: 10193489478433(each), 40193489478 …

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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Class IIOngoingZ-2674-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems S…

Potential sterility breach in sealing area of sterile pouch. If used, issue may result in moderate localized infection. If discovered prior to use, may result in clinically insignificant extension of surgery to find anot…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2673-2026

Zimmer Surgical Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…

Pneumatic Tourniquet
Under Investigation by firm

Zimmer Surgical IncOHJul 8, 2026

Class IIOngoingZ-2672-2026

W L Gore & Associates, Inc. recalls GORE¿ TAG¿ Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Re…

Due to catheter separation

Aortic Aneurysm Treatment Endovascular Graft System
Under Investigation by firm

W L Gore & Associates,…AZJul 8, 2026