CLASS II ONGOING Device recall · Reported 26 Nov 2025 · FDA Enforcement Report
Medline convenience kits labeled as: General Laparoscopy recalled
Medline Industries is recalling Medline convenience kits labeled as: General Laparoscopy, distributed nationwide in the US. The recall was initiated on 30 Sep 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0521-2026
- FDA event ID
- 97846
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 Sep 2025
- FDA classified
- 14 Nov 2025
- Reported
- 26 Nov 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 30 Sep 2025 | Recall initiated by company | |
| 14 Nov 2025 | Classified by FDA | +45 days |
| 26 Nov 2025 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
MEDLINE convenience kits labeled as: 1) GENERAL LAPAROSCOPY, REF CDS930027W; 2) GENERAL MAJOR CDS, REF CDS980245X; 3) BASIC GENERAL CDS, REF CDS980566F; 4) TOTAL KNEE CDS, REF CDS982823R; 5) BASIC CDS, REF CDS982936U; 6) UPPER EXTREMITY CDS, REF CDS983907M; 7) MAJOR ABDOMINAL CDS, REF CDS983908Q; 8) LOWER EXTREMITY CDS, REF CDS983909Q; 9) GENERAL SURGERY CDS, REF CDS983914M; 10) GENERAL ORTHO CDS, REF CDS983915N; 11) GENERAL LAP, REF CDS984251O; 12) ROBOTIC, REF CDS984262O; 13) HYPOSPADIUS PACK, REF DYNJ00282Q; 14) MINOR HARPER PACK-LF, REF DYNJ0161694F; 15) THROMBECTOMY HARPER PACK-LF, REF DYNJ0161832F; 16) MAJOR COMPONENT HARPER PACK-LF, REF DYNJ0161949C; 17) MINOR PACK-LF, REF DYNJ0259893T; 18) TOTAL KNEE PACK LF, REF DYNJ0368519AA; 19) TOTAL KNEE PACK LF, REF DYNJ0368519Y; 20) PEDIATRIC BASIC PACK-LF, REF DYNJ0406353N; 21) DONOR FREE FLAP PACK-LF, REF DYNJ0426069O; 22) DONOR FREE FLAP PACK-LF, REF DYNJ0426069P; 23) VASCULAR PACK-LF, REF DYNJ0429345R; 24) GENERAL PACK-LF, REF DYNJ0506906S; 25) BASIC PACK-LF, REF DYNJ0519294K; 26) TOTAL HIP PACK-LF, REF DYNJ0537284AC; 27) TOTAL HIP PACK-LF, REF DYNJ0537284AD; 28) BASIC MAJOR PACK-LF, REF DYNJ0537337AA; 29) BASIC MAJOR PACK-LF, REF DYNJ0537337Y; 30) BASIC GENERAL PACK-LF, REF DYNJ14004N; 31) MVFF/FIBU #54-RF, REF DYNJ21927S; 32) AUGMENTATION #87-RF, REF DYNJ27319W; 33) BASIC SET-UP, REF DYNJ34979B; 34) BASIC PACK, REF DYNJ35834D; 35) MINOR SINGLE BASIN PACK, REF DYNJ37698M; 36) ISSAQUAH PEDIATRIC PACK, REF DYNJ39001F; 37) TOTAL JOINT PACK, REF DYNJ40982F; 38) BASIC PACK, REF DYNJ42791F; 39) TOTAL JOINT PACK, REF DYNJ42793F; 40) RRP PACK, REF DYNJ44109F; 41) CENTRACARE BASIC PACK, REF DYNJ44858J; 42) DONOR PACK, REF DYNJ44865G; 43) UROLOGY RECONSTRUCTION PACK, REF DYNJ44866P; 44) UROLOGY PACK, REF DYNJ44899R; 45) ENDOCRINE PACK-RF, REF DYNJ47131F; 46) ENDOCRINE PACK-RF, REF DYNJ47131G; 47) ORTHO MAJOR, REF DYNJ48131K; 48) ENDO BLADDER PACK, REF DYNJ49672M; 49) ORTHO SPINE SUPPLEMENT PACK-LF, REF DYNJ51445B; 50) MINOR GENERAL PACK, REF DYNJ53036J; 51) ACL PACK, REF DYNJ54634I; 52) READY SET CLOSE PACK, REF DYNJ57214C; 53) KIDNEY TRANSPLANT, REF DYNJ57455C; 54) TOTAL HIP PACK, REF DYNJ58563F; 55) TOTAL HIP PACK, REF DYNJ58563G; 56) TOTAL KNEE PACK, REF DYNJ58564F; 57) TRANSPLANT PACK, REF DYNJ59201D; 58) PACK RECTAL, REF DYNJ60156C; 59) C-SECTION PK CABRINI, REF DYNJ60577B; 60) MINI KIT PACK CABRINI, REF DYNJ60579B; 61) MAJOR GENERAL CHRISTUS, REF DYNJ61184D; 62) PK CUST BASIC PK CHRISTUS, REF DYNJ61647B; 63) THORACIC PACK, REF DYNJ62015B; 64) MAJOR GENERAL PACK, REF DYNJ62397B; 65) VASCULAR PACK, REF DYNJ62683D; 66) GENDER AFFIRMING SURGERY, REF DYNJ66252C; 67) GENDER AFFIRMING SURGERY, REF
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
REF 24BBC860: UDI/DI 10195327601492 (each), 40195327601493 (case), Lot Numbers: 24BBC860; REF 24BBU607: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24BBU607; REF 24CBU583: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24CBU583; REF 24EBE546: UDI/DI 10193489848434 (each), 40193489848435 (case), Lot Numbers: 24EBE546; REF 23GBF733: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 23GBF733; REF 24ABG140: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24ABG140; REF 24BBN521: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24BBN521; REF 24CBR696: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24CBR696; REF 24EBK857: UDI/DI 10193489445442 (each), 40193489445443 (case), Lot Numbers: 24EBK857; REF 24ABH200: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24ABH200; REF 24BBG787: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24BBG787; REF 24CBI679: UDI/DI 10195327584481 (each), 40195327584482 (case), Lot Numbers: 24CBI679; REF 23GBS700: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 23GBS700; REF 24ABG363: UDI/DI 10195327185220 (each), 40195327185221 (case), Lot Numbers: 24ABG363; REF 24BBH950: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBH950; REF 24BBR420: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24BBR420; REF 24CBV474: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24CBV474; REF 24EBS619: UDI/DI 10195327584498 (each), 40195327584499 (case), Lot Numbers: 24EBS619; REF 24ABQ767: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABQ767; REF 24ABS333: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24ABS333; REF 24EBP558: UDI/DI 10195327584450 (each), 40195327584451 (case), Lot Numbers: 24EBP558; REF 24ABL655: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24ABL655; REF 24CBI698: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24CBI698; REF 24EBJ019: UDI/DI 10195327584511 (each), 40195327584512 (case), Lot Numbers: 24EBJ019; REF 24FBE329: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBE329; REF 24FBI206: UDI/DI 10195327584474 (each), 40195327584475 (case), Lot Numbers: 24FBI206; REF 24BBC411: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24BBC411; REF 24CBD731: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24CBD731; REF 24EBM175: UDI/DI 10195327584467 (each), 40195327584468 (case), Lot Numbers: 24EBM175; REF 24BBF155: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24BBF155; REF 24CBU894: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24CBU894; REF 24FBE659: UDI/DI 10195327601485 (each), 40195327601486 (case), Lot Numbers: 24FBE659; REF 24BBE394: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBE394; REF 24BBO665: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBO665; REF 24BBV851: UDI/DI 10195327601508 (each), 40195327601509 (case), Lot Numbers: 24BBV851; REF 23EMF844: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23EMF844; REF 23HMD598: UDI/DI 10195327412029 (each), 40195327412020 (case), Lot Numbers: 23HMD598; REF 23FDA733: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23FDA733; REF 23HDB247: UDI/DI 10195327404550 (each), 40195327404551 (case), Lot Numbers: 23HDB247; REF 23EDA481: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23EDA481; REF 23FDA681: UDI/DI 10195327404574 (each), 40195327404575 (case), Lot Numbers: 23FDA681; REF 23FDB248: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB248; REF 23FDB439: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDB439; REF 23FDC293: UDI/DI 10195327304331 (each), 40195327304332 (case), Lot Numbers: 23FDC293; REF 23JMD699: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23JMD699; REF 23KMG018: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23KMG018; REF 23LMB676: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 23LMB676; REF 24CMA286: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24CMA286; REF 24EMH397: UDI/DI 10195327356750 (each), 40195327356751 (case), Lot Numbers: 24EMH397; REF 24BBG478: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24BBG478; REF 24DBA379: UDI/DI 10195327618360 (each), 40195327618361 (case), Lot Numbers: 24DBA379; REF 23LBE978: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBE978; REF 23LBN137: UDI/DI 10195327556495 (each), 40195327556496 (case), Lot Numbers: 23LBN137; REF 25CMF710: UDI/DI 10198459237010 (each), 40198459237011 (case), Lot Numbers: 25CMF710; REF 24AMG978: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24AMG978; REF 24CMF532: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532; REF 24CMF532A: UDI/DI 10195327586591 (each), 40195327586592 (case), Lot Numbers: 24CMF532A; REF 24DMD291: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMD291; REF 24DMJ889: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889; REF 24DMJ889A: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24DMJ889A; REF 24FMA003: UDI/DI 10195327689452 (each), 40195327689453 (case), Lot Numbers: 24FMA003; REF 24AMC190: UDI/DI 10195327587567 (each), 40195327587568 (case), Lot Numbers: 24AMC190; REF 23LMH286: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 23LMH286; REF 24FMG970: UDI/DI 10195327356774 (each), 40195327356775 (case), Lot Numbers: 24FMG970; REF 23GMG601: UDI/DI 10195327084851 (each), 40195327084852 (case), Lot Numbers: 23GMG601; REF 23LBL866: UDI/DI 10195327556488 (each), 40195327556489 (case), Lot Numbers: 23LBL866; REF 24DBF254: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBF254; REF 24DBS437: UDI/DI 10195327618377 (each), 40195327618378 (case), Lot Numbers: 24DBS437; REF 23LBJ656: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 23LBJ656; REF 24ABO017: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24ABO017; REF 24BBK221: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBK221; REF 24BBV641: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24BBV641; REF 24DBV052: UDI/DI 10195327558925 (each), 40195327558926 (case), Lot Numbers: 24DBV052; REF 23HMC872: UDI/DI 10195327418502 (each), 40195327418503 (case), Lot Numbers: 23HMC872; REF 23FBD394: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23FBD394; REF 23GBA320: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23GBA320; REF 23HBP909: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23HBP909; REF 23KBI977: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 23KBI977; REF 24ABP890: UDI/DI 10193489873887 (each), 40193489873888 (case), Lot Numbers: 24ABP890; REF 24ABW268: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24ABW268; REF 24BBN342: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24BBN342; REF 24CBV435: UDI/DI 10195327576233 (each), 40195327576234 (case), Lot Numbers: 24CBV435; REF 24BBT429: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24BBT429; REF 24DBO680: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24DBO680; REF 24EBB580: UDI/DI 10195327576349 (each), 40195327576340 (case), Lot Numbers: 24EBB580; REF 23IMB907: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23IMB907; REF 23LMB648: UDI/DI 10193489733006 (each), 40193489733007 (case), Lot Numbers: 23LMB648; REF 23FMI945: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23FMI945; REF 23GMC968: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMC968; REF 23GMD789: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23GMD789; REF 23HMC393: UDI/DI 10195327411992 (each), 40195327411993 (case), Lot Numbers: 23HMC393; REF 24LMD228: UDI/DI 10198459170287 (each), 40198459170288 (case), Lot Numbers: 24LMD228; REF 24AMC149: UDI/DI 10195327529727 (each), 40195327529728 (case), Lot Numbers: 24AMC149; REF 24EBP778: UDI/DI 10195327651947 (each), 40195327651948 (case), Lot Numbers: 24EBP778; REF 23KMF307: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 23KMF307; REF 24BBO859: UDI/DI 10193489827538 (each), 40193489827539 (case), Lot Numbers: 24BBO859; REF 24CBP376: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24CBP376; REF 24DBK029: UDI/DI 10195327653538 (each), 40195327653539 (case), Lot Numbers: 24DBK029; REF 25BMA362: UDI/DI 10198459157882 (each), 40198459157883 (case), Lot Numbers: 25BMA362; REF 23EBH918: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23EBH918; REF 23FBP180: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23FBP180; REF 23GBI066: UDI/DI 10195327127336 (each), 40195327127337 (case), Lot Numbers: 23GBI066; REF 23GBI768: UDI/DI 10195327127633 (each), 40195327127634 (case), Lot Numbers: 23GBI768; REF 23FDB675: UDI/DI 10195327127640 (each), 40195327127641 (case), Lot Numbers: 23FDB675; REF 23HMF595: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23HMF595; REF 23JMB651: UDI/DI 10195327127763 (each), 40195327127764 (case), Lot Numbers: 23JMB651; REF 23FBS399: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23FBS399; REF 23GBU051: UDI/DI 10195327104481 (each), 40195327104482 (case), Lot Numbers: 23GBU051; REF 23LBQ322: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 23LBQ322; REF 24ABB411: UDI/DI 10195327580445 (each), 40195327580446 (case), Lot Numbers: 24ABB411; REF 24ABE534: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABE534; REF 24ABM168: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24ABM168; REF 24BBP488: UDI/DI 10195327349455 (each), 40195327349456 (case), Lot Numbers: 24BBP488; REF 23EDA769: UDI/DI 10195327298241 (each), 40195327298242 (case), Lot Numbers: 23EDA769; REF 25CME293: UDI/DI 10198459004162 (each), 40198459004163 (case), Lot Numbers: 25CME293; REF 24DBQ236: UDI/DI 10195327683641 (each), 40195327683642 (case), Lot Numbers: 24DBQ236; REF 24BME129: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24BME129; REF 24CMA954: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24CMA954; REF 24DMF816: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24DMF816; REF 24FMG334: UDI/DI 10195327622442 (each), 40195327622443 (case), Lot Numbers: 24FMG334; REF 23GBF882: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23GBF882; REF 23LBF959: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 23LBF959; REF 24FMC274: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FMC274; REF 24FME602: UDI/DI 10195327437206 (each), 40195327437207 (case), Lot Numbers: 24FME602; REF 23LBQ748: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 23LBQ748; REF 24ABV036: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24ABV036; REF 24DBA039: UDI/DI 10195327104757 (each), 40195327104758 (case), Lot Numbers: 24DBA039; REF 24BME600: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24BME600; REF 24CMD450: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24CMD450; REF 24FMH050: UDI/DI 10195327615253 (each), 40195327615254 (case), Lot Numbers: 24FMH050; REF 25AMB211: UDI/DI 10198459218798 (each), 40198459218799 (case), Lot Numbers: 25AMB211; REF 24CMJ290: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24CMJ290; REF 24DMJ919: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24DMJ919; REF 24FMG191: UDI/DI 10195327615260 (each), 40195327615261 (case), Lot Numbers: 24FMG191; REF 24ALA025: UDI/DI 10195327465490 (each), 40195327465491 (case), Lot Numbers: 24ALA025; REF 23KMJ737: UDI/DI 10195327425425 (each), 40195327425426 (case), Lot Numbers: 23KMJ737; REF 23KBF763: UDI/DI 10195327547721 (each), 40195327547722 (case), Lot Numbers: 23KBF763; REF 23KBF750: UDI/DI 10195327547752 (each), 40195327547753 (case), Lot Numbers: 23KBF750; REF 23KBE945: UDI/DI 10195327543204 (each), 40195327543205 (case), Lot Numbers: 23KBE945; REF 23KBV078: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23KBV078; REF 23LBV307: UDI/DI 10195327506179 (each), 40195327506170 (case), Lot Numbers: 23LBV307; REF 23HBI144: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23HBI144; REF 23JBD981: UDI/DI 10195327401061 (each), 40195327401062 (case), Lot Numbers: 23JBD981; REF 23DBJ748: UDI/DI 10193489873917 (each), 40193489873918 (case), Lot Numbers: 23DBJ748; REF 23LBF100: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 23LBF100; REF 24ABP681: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABP681; REF 24ABQ390: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABQ390; REF 24ABR344: UDI/DI 10195327556518 (each), 40195327556519 (case), Lot Numbers: 24ABR344; REF 24ABT457: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24ABT457; REF 24BBN976: UDI/DI 10195327573508 (each), 40195327573509 (case), Lot Numbers: 24BBN976; REF 24DBN478: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24DBN478; REF 24EBB279: UDI/DI 10195327665371 (each), 40195327665372 (case), Lot Numbers: 24EBB279; REF 24DBP727: UDI/DI 10195327653378 (each), 40195327653379 (case), Lot Numbers: 24DBP727; REF 23HMC391: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391; REF 23HMC391A: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23HMC391A; REF 23IMF472: UDI/DI 10195327472962 (each), 40195327472963 (case), Lot Numbers: 23IMF472; REF 23EBC299: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBC299; REF 23EBD393: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23EBD393; REF 23FBQ644: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBQ644; REF 23FBR335: UDI/DI 10195327299675 (each), 40195327299676 (case), Lot Numbers: 23FBR335; REF 24ABR941: UDI/DI 10195327578480 (each), 40195327578481 (case), Lot Numbers: 24ABR941; REF 23HMD614: UDI/DI 10195327352585 (each), 40195327352586 (case), Lot Numbers: 23HMD614; REF 23HMD699: UDI/DI 10195327352547 (each), 40195327352548 (case), Lot Numbers: 23HMD699; REF 23JMA869: UDI/DI 10195327512026 (each), 40195327512027 (case), Lot Numbers: 23JMA869; REF 24ABP075: UDI/DI 10195327542078 (each), 40195327542079 (case), Lot Numbers: 24ABP075; REF 23HBF482: UDI/DI 10195327422547 (each), 40195327422548 (case), Lot Numbers: 23HBF482; REF 23GBM786: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23GBM786; REF 23JBF877: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23JBF877; REF 23KBF328: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 23KBF328; REF 24ABR880: UDI/DI 10195327331207 (each), 40195327331208 (case), Lot Numbers: 24ABR880; REF 23EBO892: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23EBO892; REF 23GBN260: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 23GBN260; REF 24ABU344: UDI/DI 10195327218980 (each), 40195327218981 (case), Lot Numbers: 24ABU344; REF 24BBA167: UDI/DI 10195327618599 (each), 40195327618590 (case), Lot Numbers: 24BBA167; REF 23LBM994: UDI/DI 10195327569396 (each), 40195327569397 (case), Lot Numbers: 23LBM994; REF 24DBQ086: UDI/DI 10195327689780 (each), 40195327689781 (case), Lot Numbers: 24DBQ086; REF 24FMH614: UDI/DI 10198459046179 (each), 40198459046170 (case), Lot Numbers: 24FMH614; REF 23JBJ315: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23JBJ315; REF 23LBL460: UDI/DI 10195327484453 (each), 40195327484454 (case), Lot Numbers: 23LBL460; REF 24BBF647: UDI/DI 10195327556501 (each), 40195327556502 (case), Lot Numbers: 24BBF647; REF 24KMD557: UDI/DI 10195327684976 (each), 40195327684977 (case), Lot Numbers: 24KMD557; REF 24FMC551: UDI/DI 10195327697471 (each), 40195327697472 (case), Lot Numbers: 24FMC551; REF 23GBK061: UDI/DI 10193489915112 (each), 40193489915113 (case), Lot Numbers: 23GBK061; REF 24ABP586: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24ABP586; REF 24BBQ527: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24BBQ527; REF 24CBM211: UDI/DI 10195327554040 (each), 40195327554041 (case), Lot Numbers: 24CBM211; REF 24ALA564: UDI/DI 10195327540388 (each), 40195327540389 (case), Lot Numbers: 24ALA564; REF 23JMH334: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23JMH334; REF 23KMC378: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23KMC378; REF 23LMG820: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 23LMG820; REF 24AME239: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24AME239; REF 24CMA078: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24CMA078; REF 24DME143: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24DME143; REF 24EMA859: UDI/DI 10195327244545 (each), 40195327244546 (case), Lot Numbers: 24EMA859; REF 23IDA164: UDI/DI 10193489282818 (each), 40193489282819 (case), Lot Numbers: 23IDA164; REF 23EDB532: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23EDB532; REF 23FDB404: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23FDB404; REF 23IDA596: UDI/DI 10195327126278 (each), 40195327126279 (case), Lot Numbers: 23IDA596; REF 24BBB064: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBB064; REF 24BBH257: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24BBH257; REF 24DBL795: UDI/DI 10195327453206 (each), 40195327453207 (case), Lot Numbers: 24DBL795; REF 23LBE717: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 23LBE717; REF 24ABK008: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24ABK008; REF 24FBA280: UDI/DI 10195327482305 (each), 40195327482306 (case), Lot Numbers: 24FBA280; REF 23JBE392: UDI/DI 10195327344412 (each), 40195327344413 (case), Lot Numbers: 23JBE392; REF 23EBP184: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23EBP184; REF 23FBO482: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23FBO482; REF 23HBE220: UDI/DI 10193489436556 (each), 40193489436557 (case), Lot Numbers: 23HBE220; REF 24CMF366: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24CMF366; REF 24EMJ009: UDI/DI 10195327651336 (each), 40195327651337 (case), Lot Numbers: 24EMJ009; REF 23HBN222: UDI/DI 10195327313449 (each), 40195327313440 (case), Lot Numbers: 23HBN222; REF 24DBU838: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24DBU838; REF 24FBD404: UDI/DI 10195327622374 (each), 40195327622375 (case), Lot Numbers: 24FBD404; REF 24BBT683: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24BBT683; REF 24GBH489: UDI/DI 10195327606589 (each), 40195327606580 (case), Lot Numbers: 24GBH489; REF 23EME689: UDI/DI 10193489877328 (each), 40193489877329 (case), Lot Numbers: 23EME689; REF 24BMC531: UDI/DI 10195327617769 (each), 40195327617760 (case), Lot Numbers: 24BMC531; REF 23HDB171: UDI/DI 10195327454180 (each), 40195327454181 (case), Lot Numbers: 23HDB171; REF 23HDB144: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23HDB144; REF 23JDB494: UDI/DI 10195327454210 (each), 40195327454211 (case), Lot Numbers: 23JDB494.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
18 other products · FDA event 97846This product is part of a recall event; the main page for the event is Medline convenience kits labeled as: Ach Plastics Breast-lf recalled.
More recalls from Medline Industries
All 709| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Burgundy recalled | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS II | Rollator, Bariatric, Basic Steel, Blue recalled by Medline Industries | Medline Industries | Foreign Material | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Device Malfunction | Nationwide |
| Device | CLASS I | Medline Basic Homecare Beds and Medlite Homecare Beds recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline Convenience Kits: Major Pack recalled by Medline Industries | Medline Industries | Other | Nationwide |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | TufTex¿ Over-the-Wire Embolectomy Catheter recalled | LeMaitre Vascular | Other | Nationwide |
| Device | CLASS II | Endovascular Pack kits recalled by Avid Medical | Avid Medical | Other | Nationwide |
| Device | CLASS II | Bard Ep Xt Decapolar Steerable, Diagnostic Ep Catheter, 6f recalled | Stryker Sustainability Solutions | Particulate Matter | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |
| Device | CLASS II | Medical convenience kits containing BD CliniClean Pericare recalled | American Contract Systems | Device Malfunction | Nationwide |