Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) C-SECTION OR 30 CDS
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.
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 labeled as: 1) C-SECTION OR 30 CDS, REF CDS820075W; 2) C-SECTION, REF CDS984261J; 3) C-SECTION CDS, REF CDS985282F; 4) C-SECTION PACK, REF DYNJ02577D; 5) C-SECTION PACK-LF, REF DYNJ0536924U; 6) C-SECTION PACK-LF, REF DYNJ0551169V; 7) C-SECTION PACK-LF, REF DYNJ0551409P; 8) C-SECTION PACK-LF, REF DYNJ07836R; 9) C-SECTION, REF DYNJ14103C; 10) C-SECTION PACK, REF DYNJ19417R; 11) C-SECTION PACK-LF, REF DYNJ33059B; 12) C-SECTION PACK SC-LF, REF DYNJ38063D; 13) C-SECTION PACK SC-LF, REF DYNJ38700G; 14) C-SECTION PACK-LF, REF DYNJ38845D; 15) C-SECTION PACK-LF, REF DYNJ38845F; 16) C-SECTION PACK, REF DYNJ44679L; 17) C-SECTION DELIVERY PACK-LF, REF DYNJ47808F; 18) C SECTION PACK, REF DYNJ48087I; 19) C-SECTION I, REF DYNJ51354B; 20) C-SECTION SAFETY PACK, REF DYNJ52481B; 21) C-SECTION SMMC, REF DYNJ59457B; 22) C-SECTION PACK, REF DYNJ59825A; 23) PK CUST C-SECTION ST MICH, REF DYNJ60544C; 24) C SECTION PACK, REF DYNJ64377D; 25) C-SECTION PACK, REF DYNJ64505B; 26) C SECTION SHARED, REF DYNJ64775C; 27) LDRP-C SECTION PACK-LF, REF DYNJ64834A; 28) LDRP-C SECTION PACK-LF, REF DYNJ64834B; 29) C-SECTION PACK-LF, REF DYNJ65031D; 30) C SECTION PK, REF DYNJ65403A; 31) C SECTION PACK-LF, REF DYNJ65765A; 32) C-SECTION PACK-LF, REF DYNJ69445; 33) C-SECTION PACK-LF, REF DYNJ69445A; 34) C SECTION DELIVERY PACK, REF DYNJ81604A; 35) C SECTION DELIVERY PACK, REF DYNJ81604B; 36) C SECTION PACK, REF DYNJ82949; 37) C-SECTION ADD ON PACK, REF DYNJ83507; 38) C-SECTION PACK, REF DYNJ83980; 39) C SECTION ACCESS, REF DYNJ85612; 40) ISSAQUAH C-SECTION PACK-LF, REF DYNJ85770; 41) C-SECTION PACK, REF DYNJ86173; 42) C-SECTION, REF DYNJ900266F; 43) C-SECTION, REF DYNJ903865D; 44) C-SECTION, REF DYNJ904612G; 45) C-SECTION, REF DYNJ904612I; 46) C-SECTION, REF DYNJ904653G; 47) C-SECTION, REF DYNJ904697F; 48) CDS C-SECTION CH, REF DYNJ906263D; 49) C SECTION, REF DYNJ908327; 50) C-SECTION -LF, REF DYNJ9932207R; 51) C-SECTION -LF, REF DYNJ9932207S; 52) C-SECTION PACK, REF DYNJV0322A; 53) GP-C SECTION PACK-LF, REF PHS396980007C.
Lot / code information
- REF
- CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case)
- Lot #
- 23JBR313
- REF
- CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case)
- Lot #
- 23KBB240
- REF
- CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case)
- Lot #
- 24DBA895
- REF
- CDS820075W, UDI/DI: 10195327209797 (each) 40195327209798 (case)
- Lot #
- 24EBI651
- REF
- CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case)
- Lot #
- 23FBP399
- REF
- CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case)
- Lot #
- 23HBP624
- REF
- CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case)
- Lot #
- 23IBE037
- REF
- CDS984261J, UDI/DI: 10195327139629 (each) 40195327139620 (case)
- Lot #
- 23JBC747
- REF
- CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case)
- Lot #
- 23LBM204
- REF
- CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case)
- Lot #
- 24ABL069
- REF
- CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case)
- Lot #
- 24CBM113
- REF
- CDS985282F, UDI/DI: 10193489645606 (each) 40193489645607 (case)
- Lot #
- 24FBE246
- REF
- DYNJ02577D, UDI/DI: 10193489958003 (each) 40193489958004 (case)
- Lot #
- 23EDA073
- REF
- DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case)
- Lot #
- 23GBP147
- REF
- DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case)
- Lot #
- 23HBD395
- REF
- DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case)
- Lot #
- 23HBP685
- REF
- DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case)
- Lot #
- 24BBV536
- REF
- DYNJ0536924U, UDI/DI: 10195327206246 (each) 40195327206247 (case)
- Lot #
- 24EBF239
- REF
- DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case)
- Lot #
- 23HMD981
- REF
- DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case)
- Lot #
- 23KBF163
- REF
- DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case)
- Lot #
- 24BBH765
- REF
- DYNJ0551169V, UDI/DI: 10889942826582 (each) 40889942826583 (case)
- Lot #
- 24BBT798
- REF
- DYNJ0551409P, UDI/DI: 10195327561871 (each) 40195327561872 (case)
- Lot #
- 24BBC833
- REF
- DYNJ07836R, UDI/DI: 10195327349431 (each) 40195327349432 (case)
- Lot #
- 24BBH764
- REF
- DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case)
- Lot #
- 23LBC980
- REF
- DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case)
- Lot #
- 24ABQ944
- REF
- DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case)
- Lot #
- 24ABR003
- REF
- DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case)
- Lot #
- 24ABV987
- REF
- DYNJ14103C, UDI/DI: 10195327496609 (each) 40195327496600 (case)
- Lot #
- 24BBG949
- REF
- DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case)
- Lot #
- 23GMF903
- REF
- DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case)
- Lot #
- 23HMF589
- REF
- DYNJ19417R, UDI/DI: 10195327351373 (each) 40195327351374 (case)
- Lot #
- 23JMB497
- REF
- DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case)
- Lot #
- 23EBO244
- REF
- DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case)
- Lot #
- 23FBR011
- REF
- DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case)
- Lot #
- 23HBD673
- REF
- DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case)
- Lot #
- 23HBH801
- REF
- DYNJ33059B, UDI/DI: 10193489950946 (each) 40193489950947 (case)
- Lot #
- 23IBP528
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23DMF816
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23DMI790
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23EMG135
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23FMI968
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23GMI116
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23HMA195
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 23JMC837
- REF
- DYNJ38063D, UDI/DI: 10195327034757 (each) 40195327034758 (case)
- Lot #
- 24BMB829
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 23DMI785
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 23EMJ326
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 23GMD537
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 23IMF534
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 23KMB242
- REF
- DYNJ38700G, UDI/DI: 10195327050528 (each) 40195327050529 (case)
- Lot #
- 24BMC270
- REF
- DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case)
- Lot #
- 23HBQ392
- REF
- DYNJ38845D, UDI/DI: 10193489860832 (each) 40193489860833 (case)
- Lot #
- 23LBT819
- REF
- DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case)
- Lot #
- 24CBM675
- REF
- DYNJ38845F, UDI/DI: 10195327653354 (each) 40195327653355 (case)
- Lot #
- 24EBP120
- REF
- DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case)
- Lot #
- 23EBK092
- REF
- DYNJ44679L, UDI/DI: 10195327127381 (each) 40195327127382 (case)
- Lot #
- 23EBS759
- REF
- DYNJ47808F, UDI/DI: 10195327232603 (each) 40195327232604 (case)
- Lot #
- 23GMI543
- REF
- DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case)
- Lot #
- 24ABE884
- REF
- DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case)
- Lot #
- 24BBI603
- REF
- DYNJ48087I, UDI/DI: 10195327500054 (each) 40195327500055 (case)
- Lot #
- 24CBU107
- REF
- DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case)
- Lot #
- 23JME469
- REF
- DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case)
- Lot #
- 23KMH696
- REF
- DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case)
- Lot #
- 24DMD663
- REF
- DYNJ51354B, UDI/DI: 10193489878257 (each) 40193489878258 (case)
- Lot #
- 24KMD766
- REF
- DYNJ52481B, UDI/DI: 10195327689773 (each) 40195327689774 (case)
- Lot #
- 24DBO831
- REF
- DYNJ59457B, UDI/DI: 10195327446574 (each) 40195327446575 (case)
- Lot #
- 23KMD078
- REF
- DYNJ59825A, UDI/DI: 10195327331610 (each) 40195327331611 (case)
- Lot #
- 23HLA627
- REF
- DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case)
- Lot #
- 23EBD197
- REF
- DYNJ60544C, UDI/DI: 10195327361983 (each) 40195327361984 (case)
- Lot #
- 23EBR612
- REF
- DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case)
- Lot #
- 23EBB409
- REF
- DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case)
- Lot #
- 23GBG734
- REF
- DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case)
- Lot #
- 23HBM866
- REF
- DYNJ64377D, UDI/DI: 10195327233600 (each) 40195327233601 (case)
- Lot #
- 23IBR809
- REF
- DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case)
- Lot #
- 23HBI631
- REF
- DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case)
- Lot #
- 24ABI243
- REF
- DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case)
- Lot #
- 24BBC533
- REF
- DYNJ64505B, UDI/DI: 10195327115388 (each) 40195327115389 (case)
- Lot #
- 24DBO874
- REF
- DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case)
- Lot #
- 23EDC402
- REF
- DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case)
- Lot #
- 23FDC227
- REF
- DYNJ64775C, UDI/DI: 10195327221232 (each) 40195327221233 (case)
- Lot #
- 23HDB277
- REF
- DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case)
- Lot #
- 23IMG148
- REF
- DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case)
- Lot #
- 23JME325
- REF
- DYNJ64834A, UDI/DI: 10195327439712 (each) 40195327439713 (case)
- Lot #
- 23LMA555
- REF
- DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case)
- Lot #
- 24AMF996
- REF
- DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case)
- Lot #
- 24BMI121
- REF
- DYNJ64834B, UDI/DI: 10195327601072 (each) 40195327601073 (case)
- Lot #
- 24CMF007
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 23KMI521
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 23LMF119
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 24AMC075
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 24CMI550
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 24EMH988
- REF
- DYNJ65031D, UDI/DI: 10195327528171 (each) 40195327528172 (case)
- Lot #
- 24FME482
- REF
- DYNJ65403A, UDI/DI: 10193489417081 (each) 40193489417082 (case)
- Lot #
- 24ABS258
- REF
- DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case)
- Lot #
- 23EBO612
- REF
- DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case)
- Lot #
- 23HBR353
- REF
- DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case)
- Lot #
- 23IBJ604
- REF
- DYNJ65765A, UDI/DI: 10193489420739 (each) 40193489420730 (case)
- Lot #
- 23KBD084
- REF
- DYNJ69445, UDI/DI: 10193489942514 (each) 40193489942515 (case)
- Lot #
- 23GBA532
- REF
- DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case)
- Lot #
- 23KBU661
- REF
- DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case)
- Lot #
- 24BBH876
- REF
- DYNJ69445A, UDI/DI: 10195327528690 (each) 40195327528691 (case)
- Lot #
- 24BBI439
- REF
- DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case)
- Lot #
- 23DBJ057
- REF
- DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case)
- Lot #
- 23EBN921
- REF
- DYNJ81604A, UDI/DI: 10195327314996 (each) 40195327314997 (case)
- Lot #
- 23FBB765
- REF
- DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case)
- Lot #
- 23GBK114
- REF
- DYNJ81604B, UDI/DI: 10195327442514 (each) 40195327442515 (case)
- Lot #
- 23JBK156
- REF
- DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case)
- Lot #
- 23EBM401
- REF
- DYNJ82949, UDI/DI: 10195327218959 (each) 40195327218950 (case)
- Lot #
- 23IBQ454
- REF
- DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case)
- Lot #
- 23HBW089
- REF
- DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case)
- Lot #
- 23IBK153
- REF
- DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case)
- Lot #
- 23LBU485
- REF
- DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case)
- Lot #
- 23LBV117
- REF
- DYNJ83507, UDI/DI: 10195327273071 (each) 40195327273072 (case)
- Lot #
- 24DBR994
- REF
- DYNJ83980, UDI/DI: 10195327323554 (each) 40195327323555 (case)
- Lot #
- 24ABR096
- REF
- DYNJ85612, UDI/DI: 10195327523770 (each) 40195327523771 (case)
- Lot #
- 23LMF612
- REF
- DYNJ85770, UDI/DI: 10195327546557 (each) 40195327546558 (case)
- Lot #
- 24AMG054
- REF
- DYNJ86173, UDI/DI: 10195327609412 (each) 40195327609413 (case)
- Lot #
- 24CBA422
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 23LBG515
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 23LBQ424
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 24ABG727
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 24ABS178
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 24ABW963
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 24BBQ451
- REF
- DYNJ900266F, UDI/DI: 10195327542993 (each) 40195327542994 (case)
- Lot #
- 24CBT653
- REF
- DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case)
- Lot #
- 23KMD690
- REF
- DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case)
- Lot #
- 23LMG846
- REF
- DYNJ903865D, UDI/DI: 10195327239107 (each) 40195327239108 (case)
- Lot #
- 24AMG510
- REF
- DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case)
- Lot #
- 23LMC684
- REF
- DYNJ904612G, UDI/DI: 10195327480134 (each) 40195327480135 (case)
- Lot #
- 24AMA761
- REF
- DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case)
- Lot #
- 24CMH459
- REF
- DYNJ904612I, UDI/DI: 10195327644451 (each) 40195327644452 (case)
- Lot #
- 24GMH592
- REF
- DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case)
- Lot #
- 23HBH779
- REF
- DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case)
- Lot #
- 23IBP238
- REF
- DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case)
- Lot #
- 23JBS995
- REF
- DYNJ904653G, UDI/DI: 10195327277659 (each) 40195327277650 (case)
- Lot #
- 23KBM075
- REF
- DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case)
- Lot #
- 23EDB517
- REF
- DYNJ904697F, UDI/DI: 10195327169275 (each) 40195327169276 (case)
- Lot #
- 23FDB192
- REF
- DYNJ906263D, UDI/DI: 10195327344375 (each) 40195327344376 (case)
- Lot #
- 23HBJ335
- REF
- DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case)
- Lot #
- 23HMD044
- REF
- DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case)
- Lot #
- 23JMH952
- REF
- DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case)
- Lot #
- 23KMF087
- REF
- DYNJ908327, UDI/DI: 10195327036652 (each) 40195327036653 (case)
- Lot #
- 24AMB283
- REF
- DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case)
- Lot #
- 23GMI390
- REF
- DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case)
- Lot #
- 23KMJ296
- REF
- DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case)
- Lot #
- 23LMH787
- REF
- DYNJ9932207R, UDI/DI: 10193489624151 (each) 40193489624152 (case)
- Lot #
- 24BMJ492
- REF
- DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case)
- Lot #
- 24DMG311
- REF
- DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case)
- Lot #
- 24FMB530
- REF
- DYNJ9932207S, UDI/DI: 10195327652371 (each) 40195327652372 (case)
- Lot #
- 24HMJ414
- REF
- DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case)
- Lot #
- 23JMF237
- REF
- DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case)
- Lot #
- 23KMG863
- REF
- DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case)
- Lot #
- 24AMI231
- REF
- DYNJV0322A, UDI/DI: 10195327515935 (each) 40195327515936 (case)
- Lot #
- 24HMD222
- REF
- PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case)
- Lot #
- 23GDB702
- REF
- PHS396980007C, UDI/DI: 10195327454173 (each) 40195327454174 (case)
- Lot #
- 23HDA942
Show 302 more code fieldsShow fewer
What the firm is doing
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: 1. Immediately check 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 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. 3. 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. 4. 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. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
DistributionShow detailsHide
US Nationwide distribution.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-0526-2026
- FDA device classification · OHMOfficial FDA classification for this device type
- CFR regulation · 21 CFR 884.1720The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Medline Industries, LPSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
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 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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