{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216736", "product_res_number": "Z-0521-2026", "event_date_initiated": "2025-09-30", "event_date_posted": "2025-11-14", "recall_status": "Open, Classified", "res_event_number": "97846", "product_code": "LRO", "product_description": "MEDLINE convenience kits labeled as: \n1) GENERAL LAPAROSCOPY, REF CDS930027W; \n2) GENERAL MAJOR CDS, REF CDS980245X; \n3) BASIC GENERAL CDS, REF CDS980566F; \n4) TOTAL KNEE CDS, REF CDS982823R; \n5) BASIC CDS, REF CDS982936U; \n6) UPPER EXTREMITY CDS, REF CDS983907M; \n7) MAJOR ABDOMINAL CDS, REF CDS983908Q; \n8) LOWER EXTREMITY CDS, REF CDS983909Q; \n9) GENERAL SURGERY CDS, REF CDS983914M; \n10) GENERAL ORTHO CDS, REF CDS983915N; \n11) GENERAL LAP, REF CDS984251O; \n12) ROBOTIC, REF CDS984262O; \n13) HYPOSPADIUS PACK, REF DYNJ00282Q; \n14) MINOR HARPER PACK-LF, REF DYNJ0161694F; \n15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; \n16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; \n17) MINOR PACK-LF, REF DYNJ0259893T; \n18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; \n19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; \n20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; \n21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; \n22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; \n23) VASCULAR PACK-LF, REF DYNJ0429345R; \n24) GENERAL PACK-LF, REF DYNJ0506906S; \n25) BASIC PACK-LF, REF DYNJ0519294K; \n26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; \n27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; \n28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; \n29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; \n30) BASIC GENERAL PACK-LF, REF DYNJ14004N; \n31) MVFF/FIBU #54-RF, REF DYNJ21927S; \n32) AUGMENTATION #87-RF, REF DYNJ27319W; \n33) BASIC SET-UP, REF DYNJ34979B; \n34) BASIC PACK, REF DYNJ35834D; \n35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; \n36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; \n37) TOTAL JOINT PACK, REF DYNJ40982F; \n38) BASIC PACK, REF DYNJ42791F; \n39) TOTAL JOINT PACK, REF DYNJ42793F; \n40) RRP PACK, REF DYNJ44109F; \n41) CENTRACARE BASIC PACK, REF DYNJ44858J; \n42) DONOR PACK, REF DYNJ44865G; \n43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; \n44) UROLOGY PACK, REF DYNJ44899R; \n45) ENDOCRINE PACK-RF, REF DYNJ47131F; \n46) ENDOCRINE PACK-RF, REF DYNJ47131G; \n47) ORTHO MAJOR, REF DYNJ48131K; \n48) ENDO BLADDER PACK, REF DYNJ49672M; \n49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; \n50) MINOR GENERAL PACK, REF DYNJ53036J; \n51) ACL PACK, REF DYNJ54634I; \n52) READY SET CLOSE PACK, REF DYNJ57214C; \n53) KIDNEY TRANSPLANT, REF DYNJ57455C; \n54) TOTAL HIP PACK, REF DYNJ58563F; \n55) TOTAL HIP PACK, REF DYNJ58563G; \n56) TOTAL KNEE PACK, REF DYNJ58564F; \n57) TRANSPLANT PACK, REF DYNJ59201D; \n58) PACK RECTAL, REF DYNJ60156C; \n59) C-SECTION PK CABRINI, REF DYNJ60577B; \n60) MINI KIT PACK CABRINI, REF DYNJ60579B; \n61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; \n62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; \n63) THORACIC PACK, REF DYNJ62015B; \n64) MAJOR GENERAL PACK, REF DYNJ62397B; \n65) VASCULAR PACK, REF DYNJ62683D; \n66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; \n67) GENDER AFFIRMING SURGERY, REF", "code_info": "REF 24BBC860: UDI/DI 10195327601492 (each), 40195327601493 (case), Lot Numbers: 24BBC860; \nREF 24BBU607: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24BBU607; \nREF 24CBU583: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24CBU583; \nREF 24EBE546: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24EBE546; \nREF 23GBF733: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 23GBF733; \nREF 24ABG140: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24ABG140; \nREF 24BBN521: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24BBN521; \nREF 24CBR696: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24CBR696; \nREF 24EBK857: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24EBK857; \nREF 24ABH200: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24ABH200; \nREF 24BBG787: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24BBG787; \nREF 24CBI679: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24CBI679; \nREF 23GBS700: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 23GBS700; \nREF 24ABG363: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 24ABG363; \nREF 24BBH950: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBH950; \nREF 24BBR420: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBR420; \nREF 24CBV474: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24CBV474; \nREF 24EBS619: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24EBS619; \nREF 24ABQ767: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABQ767; \nREF 24ABS333: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABS333; \nREF 24EBP558: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24EBP558; \nREF 24ABL655: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24ABL655; \nREF 24CBI698: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24CBI698; \nREF 24EBJ019: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24EBJ019; \nREF 24FBE329: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBE329; \nREF 24FBI206: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBI206; \nREF 24BBC411: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24BBC411; \nREF 24CBD731: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24CBD731; \nREF 24EBM175: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24EBM175; \nREF 24BBF155: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24BBF155; \nREF 24CBU894: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24CBU894; \nREF 24FBE659: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24FBE659; \nREF 24BBE394: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBE394; \nREF 24BBO665: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBO665; \nREF 24BBV851: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBV851; \nREF 23EMF844: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23EMF844; \nREF 23HMD598: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23HMD598; \nREF 23FDA733: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23FDA733; \nREF 23HDB247: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23HDB247; \nREF 23EDA481: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23EDA481; \nREF 23FDA681: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23FDA681; \nREF 23FDB248: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB248; \nREF 23FDB439: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB439; \nREF 23FDC293: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDC293; \nREF 23JMD699: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23JMD699; \nREF 23KMG018: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23KMG018; \nREF 23LMB676: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23LMB676; \nREF 24CMA286: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24CMA286; \nREF 24EMH397: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24EMH397; \nREF 24BBG478: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24BBG478; \nREF 24DBA379: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24DBA379; \nREF 23LBE978: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBE978; \nREF 23LBN137: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBN137; \nREF 25CMF710: UDI/DI 10198459237010 (each), 40198459237011 (case), Lot Numbers: 25CMF710; \nREF 24AMG978: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24AMG978; \nREF 24CMF532: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532; \nREF 24CMF532A: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532A; \nREF 24DMD291: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMD291; \nREF 24DMJ889: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889; \nREF 24DMJ889A: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889A; \nREF 24FMA003: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24FMA003; \nREF 24AMC190: UDI/DI 10195327587567 (each), 40195327587568 (case), Lot Numbers: 24AMC190; \nREF 23LMH286: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 23LMH286; \nREF 24FMG970: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 24FMG970; \nREF 23GMG601: UDI/DI 10195327084851 (each), 40195327084852 (case), Lot Numbers: 23GMG601; \nREF 23LBL866: UDI/DI 10195327556488 (each), 40195327556489 (case), Lot Numbers: 23LBL866; \nREF 24DBF254: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBF254; \nREF 24DBS437: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBS437; \nREF 23LBJ656: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 23LBJ656; \nREF 24ABO017: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24ABO017; \nREF 24BBK221: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBK221; \nREF 24BBV641: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBV641; \nREF 24DBV052: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24DBV052; \nREF 23HMC872: UDI/DI 10195327418502 (each), 40195327418503 (case), Lot Numbers: 23HMC872; \nREF 23FBD394: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23FBD394; \nREF 23GBA320: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23GBA320; \nREF 23HBP909: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23HBP909; \nREF 23KBI977: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23KBI977; \nREF 24ABP890: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 24ABP890; \nREF 24ABW268: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24ABW268; \nREF 24BBN342: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24BBN342; \nREF 24CBV435: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24CBV435; \nREF 24BBT429: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24BBT429; \nREF 24DBO680: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24DBO680; \nREF 24EBB580: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24EBB580; \nREF 23IMB907: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23IMB907; \nREF 23LMB648: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23LMB648; \nREF 23FMI945: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23FMI945; \nREF 23GMC968: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMC968; \nREF 23GMD789: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMD789; \nREF 23HMC393: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23HMC393; \nREF 24LMD228: UDI/DI 10198459170287 (each), 40198459170288 (case), Lot Numbers: 24LMD228; \nREF 24AMC149: UDI/DI 10195327529727 (each), 40195327529728 (case), Lot Numbers: 24AMC149; \nREF 24EBP778: UDI/DI 10195327651947 (each), 40195327651948 (case), Lot Numbers: 24EBP778; \nREF 23KMF307: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 23KMF307; \nREF 24BBO859: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 24BBO859; \nREF 24CBP376: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24CBP376; \nREF 24DBK029: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24DBK029; \nREF 25BMA362: UDI/DI 10198459157882 (each), 40198459157883 (case), Lot Numbers: 25BMA362; \nREF 23EBH918: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23EBH918; \nREF 23FBP180: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23FBP180; \nREF 23GBI066: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23GBI066; \nREF 23GBI768: UDI/DI 10195327127633 (each), 40195327127634 (case), Lot Numbers: 23GBI768; \nREF 23FDB675: UDI/DI 10195327127640 (each), 40195327127641 (case), Lot Numbers: 23FDB675; \nREF 23HMF595: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23HMF595; \nREF 23JMB651: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23JMB651; \nREF 23FBS399: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23FBS399; \nREF 23GBU051: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23GBU051; \nREF 23LBQ322: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 23LBQ322; \nREF 24ABB411: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 24ABB411; \nREF 24ABE534: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABE534; \nREF 24ABM168: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABM168; \nREF 24BBP488: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24BBP488; \nREF 23EDA769: UDI/DI 10195327298241 (each), 40195327298242 (case), Lot Numbers: 23EDA769; \nREF 25CME293: UDI/DI 10198459004162 (each), 40198459004163 (case), Lot Numbers: 25CME293; \nREF 24DBQ236: UDI/DI 10195327683641 (each), 40195327683642 (case), Lot Numbers: 24DBQ236; \nREF 24BME129: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24BME129; \nREF 24CMA954: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24CMA954; \nREF 24DMF816: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24DMF816; \nREF 24FMG334: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24FMG334; \nREF 23GBF882: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23GBF882; \nREF 23LBF959: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23LBF959; \nREF 24FMC274: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FMC274; \nREF 24FME602: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FME602; \nREF 23LBQ748: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 23LBQ748; \nREF 24ABV036: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24ABV036; \nREF 24DBA039: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24DBA039; \nREF 24BME600: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24BME600; \nREF 24CMD450: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24CMD450; \nREF 24FMH050: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24FMH050; \nREF 25AMB211: UDI/DI 10198459218798 (each), 40198459218799 (case), Lot Numbers: 25AMB211; \nREF 24CMJ290: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24CMJ290; \nREF 24DMJ919: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24DMJ919; \nREF 24FMG191: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24FMG191; \nREF 24ALA025: UDI/DI 10195327465490 (each), 40195327465491 (case), Lot Numbers: 24ALA025; \nREF 23KMJ737: UDI/DI 10195327425425 (each), 40195327425426 (case), Lot Numbers: 23KMJ737; \nREF 23KBF763: UDI/DI 10195327547721 (each), 40195327547722 (case), Lot Numbers: 23KBF763; \nREF 23KBF750: UDI/DI 10195327547752 (each), 40195327547753 (case), Lot Numbers: 23KBF750; \nREF 23KBE945: UDI/DI 10195327543204 (each), 40195327543205 (case), Lot Numbers: 23KBE945; \nREF 23KBV078: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23KBV078; \nREF 23LBV307: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23LBV307; \nREF 23HBI144: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23HBI144; \nREF 23JBD981: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23JBD981; \nREF 23DBJ748: UDI/DI 10193489873917 (each), 40193489873918 (case), Lot Numbers: 23DBJ748; \nREF 23LBF100: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 23LBF100; \nREF 24ABP681: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABP681; \nREF 24ABQ390: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABQ390; \nREF 24ABR344: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABR344; \nREF 24ABT457: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24ABT457; \nREF 24BBN976: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24BBN976; \nREF 24DBN478: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24DBN478; \nREF 24EBB279: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24EBB279; \nREF 24DBP727: UDI/DI 10195327653378 (each), 40195327653379 (case), Lot Numbers: 24DBP727; \nREF 23HMC391: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391; \nREF 23HMC391A: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391A; \nREF 23IMF472: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23IMF472; \nREF 23EBC299: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBC299; \nREF 23EBD393: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBD393; \nREF 23FBQ644: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBQ644; \nREF 23FBR335: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBR335; \nREF 24ABR941: UDI/DI 10195327578480 (each), 40195327578481 (case), Lot Numbers: 24ABR941; \nREF 23HMD614: UDI/DI 10195327352585 (each), 40195327352586 (case), Lot Numbers: 23HMD614; \nREF 23HMD699: UDI/DI 10195327352547 (each), 40195327352548 (case), Lot Numbers: 23HMD699; \nREF 23JMA869: UDI/DI 10195327512026 (each), 40195327512027 (case), Lot Numbers: 23JMA869; \nREF 24ABP075: UDI/DI 10195327542078 (each), 40195327542079 (case), Lot Numbers: 24ABP075; \nREF 23HBF482: UDI/DI 10195327422547 (each), 40195327422548 (case), Lot Numbers: 23HBF482; \nREF 23GBM786: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23GBM786; \nREF 23JBF877: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23JBF877; \nREF 23KBF328: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23KBF328; \nREF 24ABR880: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 24ABR880; \nREF 23EBO892: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23EBO892; \nREF 23GBN260: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23GBN260; \nREF 24ABU344: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 24ABU344; \nREF 24BBA167: UDI/DI 10195327618599 (each), 40195327618590 (case), Lot Numbers: 24BBA167; \nREF 23LBM994: UDI/DI 10195327569396 (each), 40195327569397 (case), Lot Numbers: 23LBM994; \nREF 24DBQ086: UDI/DI 10195327689780 (each), 40195327689781 (case), Lot Numbers: 24DBQ086; \nREF 24FMH614: UDI/DI 10198459046179 (each), 40198459046170 (case), Lot Numbers: 24FMH614; \nREF 23JBJ315: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23JBJ315; \nREF 23LBL460: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23LBL460; \nREF 24BBF647: UDI/DI 10195327556501 (each), 40195327556502 (case), Lot Numbers: 24BBF647; \nREF 24KMD557: UDI/DI 10195327684976 (each), 40195327684977 (case), Lot Numbers: 24KMD557; \nREF 24FMC551: UDI/DI 10195327697471 (each), 40195327697472 (case), Lot Numbers: 24FMC551; \nREF 23GBK061: UDI/DI 10193489915112 (each), 40193489915113 (case), Lot Numbers: 23GBK061; \nREF 24ABP586: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24ABP586; \nREF 24BBQ527: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24BBQ527; \nREF 24CBM211: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24CBM211; \nREF 24ALA564: UDI/DI 10195327540388 (each), 40195327540389 (case), Lot Numbers: 24ALA564; \nREF 23JMH334: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23JMH334; \nREF 23KMC378: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23KMC378; \nREF 23LMG820: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23LMG820; \nREF 24AME239: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24AME239; \nREF 24CMA078: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24CMA078; \nREF 24DME143: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24DME143; \nREF 24EMA859: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24EMA859; \nREF 23IDA164: UDI/DI 10193489282818 (each), 40193489282819 (case), Lot Numbers: 23IDA164; \nREF 23EDB532: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23EDB532; \nREF 23FDB404: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23FDB404; \nREF 23IDA596: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23IDA596; \nREF 24BBB064: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBB064; \nREF 24BBH257: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBH257; \nREF 24DBL795: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24DBL795; \nREF 23LBE717: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 23LBE717; \nREF 24ABK008: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24ABK008; \nREF 24FBA280: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24FBA280; \nREF 23JBE392: UDI/DI 10195327344412 (each), 40195327344413 (case), Lot Numbers: 23JBE392; \nREF 23EBP184: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23EBP184; \nREF 23FBO482: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23FBO482; \nREF 23HBE220: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23HBE220; \nREF 24CMF366: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24CMF366; \nREF 24EMJ009: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24EMJ009; \nREF 23HBN222: UDI/DI 10195327313449 (each), 40195327313440 (case), Lot Numbers: 23HBN222; \nREF 24DBU838: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24DBU838; \nREF 24FBD404: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24FBD404; \nREF 24BBT683: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24BBT683; \nREF 24GBH489: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24GBH489; \nREF 23EME689: UDI/DI 10193489877328 (each), 40193489877329 (case), Lot Numbers: 23EME689; \nREF 24BMC531: UDI/DI 10195327617769 (each), 40195327617760 (case), Lot Numbers: 24BMC531; \nREF 23HDB171: UDI/DI 10195327454180 (each), 40195327454181 (case), Lot Numbers: 23HDB171; \nREF 23HDB144: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23HDB144; \nREF 23JDB494: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23JDB494.", "firm_fei_number": "1417592", "recalling_firm": "Medline Industries, LP", "address_1": "3 Lakes Dr", "city": "Northfield", "state": "IL", "postal_code": "60093-2753", "additional_info_contact": "Haley Barclay\n800-369-1704", "reason_for_recall": "Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke Evacuation Pencils previously initiated in October 2024, adding an additional 47 lots to the scope of the recall. The initial recall was due to the potential for product to activate without manual input when plugged into a power source or remain active after buttons are released.", "root_cause_description": "Under Investigation by firm", "action": "Medline issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 09/30/2025 and 10/6/2025 via email and mail. The notice explained the issue with the component, potential risk, and requested the following actions: \n1. Immediately check stock for the affected item number(s) and the affected lot number(s) listed within the recall portal. Quarantine all affected product.\n2. Please use the link and the information found in the notice to complete the response form. Please list the quantity of affected product in inventory on the form. Even if no affected product is in inventory, please complete and submit the form. \n3. Upon receipt of the submitted response form, the customer account will receive over-labels to place on affected inventory, with instructions for the customer staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.\n4. For distributors or those who 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 include your customers quantities on your response form. Upon receipt of your submitted response form, you will receive over-labels to provide to your customers to affix to their affected product.\nIf you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.", "product_quantity": "20941 kits", "distribution_pattern": "US Nationwide distribution.", "openfda": { "k_number": [ "K930270", "K964011", "K041080", "K963715", "K970187", "K935858", "K931824", "K930700", "K963443", "K935686", "K920292", "K933137", "K023276", "K925214", "K936117", "K961863", "K885090", "K873973", "K895202", "K934028", "K871322", "K934428", "K952539", "K880961", "K920267", "K884093", "K914935", "K854292", "K931673", "K212258", "K945481", "K925216", "K931760", "K910365", "K874439", "K902888", "K871437", "K935740", "K932220", "K935483", "K934688", "K932221", "K030721", "K962826", "K874760", "K941846", "K882684", "K890726", "K926269", "K950574", "K931844", "K901856", "K951149", "K961683", "K965201", "K980137", "K953083", "K945160", "K932217", "K922648", "K854095", "K934030", "K922133", "K934029", "K871459", "K890098", "K931820", "K924468", "K872011", "K872448", "K871873", "K914036", "K944044", "K842648", "K914037", "K905004", "K925467", "K971062", "K883250", "K914174", "K880942", "K945831", "K932652", "K893814", "K871434", "K935741", "K951478", "K910368", "K213481", "K902293", "K931759", "K894685", "K881083", "K903336", "K931758", "K971061", "K935743", "K923600", "K925016", "K902887", "K890570", "K950295", "K905459", "K890729", "K964921", "K970286", "K892389", "K963721", "K913136", "K890658" ], "registration_number": [ "9681709", "3005595283", "3007829657", "2029015", "1060680", "3013298431", "2029275", "9680357", "3010376936", "1055954", "1417592", "3009637528", "3007007790", "3014325891", "3009750712", "1047429", "3013466775", "1527607", "3006891803", "1047843", "3012811961", "3006271008", "3006540014", "1123010", "3006400329", "3014421917", "8030672", "3011707784", "8022032", "3002807314", "3041276890", "3010878085", "3006673317", "9616096", "3007344957", "1526711", "3042480961", "3019798849", "1063382", "3042158935", "2936485", "3006846316", "2011171", "3013735189", "2024311", "3012595397", "1721686", "3010166880", "3008824097", "1610287", "3004519921", "3045857302", "2433012", "2648727", "1823410", "3004111573", "3004911384", "3045816907", "3005400762", "3017467279", "3014680744", "3018071447", "3006191977", "3005391805", "3013421458", "3007082897", "1423395", "9616088", "3017430544", "8030678", "1018470", "3007139365", "9680143", "1644019", "3023140882", "3004122598", "1065597", "2024980", "3017636737", "1921846", "3036002406", "3031841433", "3020983482", "3006450239", "1000124971", "3010452421", "3015960676", "3004513970", "3014925393", "3016761372", "3008496560", "3002669946", "3014704068", "3018116884", "3004713352", "1422634", "3009203853", "3011270181", "9680425", "3005669815", "1423537", "1043214", "3006973666", "3013960812", "3003495693", "3015895045", "3018077422", "3011144486", "3010305275", "3026197444", "1424263", "3009773841", "1066741", "3013600605", "8022210", "9611594", "3015173212", "1061124", "1923569", "3045816902", "3004361903", "1650907", "3014718111", "9611024", "3007289408", "3008403546", "1055236", "3004605321", "3007329020", "3005997949", "1643817", "3009888344", "9614277", "1420054", "1030451", "3011532690", "3043620414", "3011554160", "1824619", "1121203", "3013502418", "1928237", "3006542380", "3004362278", "3035642068", "3003924117", "1055892", "3011494917", "3015058854", "3002806603", "3011545608", "3044906632", "1054241", "3005012805", "2320762", "3011500469", "2431166", "3005246893", "3030078769", "3016096096", "2000028362", "3027977504" ], "fei_number": [ "3005595283", "3007829657", "3002902735", "3001236905", "3013298431", "3010376936", "1000208624", "1417592", "3009637528", "3007007790", "3014325891", "3009750712", "1047429", "3013466775", "1527607", "3003040625", "3006891803", "1047843", "1000514656", "3012811961", "3006271008", "3005596530", "3006540014", "3006400329", "3014421917", "3011707784", "3005846326", "3002807314", "1000117501", "3002807170", "3041276890", "3010878085", "3003803331", "3007344957", "1526711", "3042480961", "3019798849", "3042158935", "2936485", "3006846316", "2011171", "3013735189", "2024311", "3001717360", "3012595397", "3007596547", "2523865", "1721686", "3010166880", "3008824097", "1610287", "3045857302", "3003807323", "2433012", "2648727", "1000111202", "1000306431", "1823410", "3004111573", "3004911384", "3045816907", "3005400762", "3017467279", "3014680744", "3018071447", "3006191977", "3005391805", "3013421458", "3007082897", "1000121355", "3002805559", "3017430544", "1018470", "3007139365", "3023140882", "3002681132", "1000113384", "3004122598", "3017636737", "3008373372", "1921846", "3036002406", "3020983482", "3031841433", "3006450239", "1000124971", "3010452421", "3015960676", "1000160458", "3004513970", "3014925393", "3016761372", "3008496560", "3002669946", "3014704068", "3018116884", "3002807308", "3008875470", "3004713352", "3009203853", "3011270181", "3005669815", "1000123297", "3194", "1043214", "3006973666", "3013960812", "3003495693", "1000112968", "3015895045", "3018077422", "3011144486", "3010305275", "3026197444", "3009773841", "3000718854", "1000512168", "3013600605", "3003005156", "3015173212", "3004829691", "1923569", "3045816902", "3004361903", "3007289408", "3000717925", "3008403546", "3004605321", "1000112877", "3007329020", "3005997949", "1643817", "3009888344", "1420054", "1030451", "3011532690", "3043620414", "3011554160", "1824619", "3932", "3013502418", "3003015552", "1928237", "3006542380", "3004362278", "3035642068", "3003924117", "3011494917", "3015058854", "3002806603", "3011545608", "3044906632", "3000215259", "3005012805", "3011500469", "3002692512", "3005246893", "3030078769", "3016096096", "3002806436", "2000028362", "3027977504" ], "device_name": "General Surgery Tray", "medical_specialty_description": "General, Plastic Surgery", "regulation_number": "878.4370", "device_class": "2" } } ] }