Medline Industries, LP recalls Medline medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF
Reason for recall
Medline kits containing Stryker's Strykeflow 2 Suction Irrigators due to a change in design in 2024, irrigation solution is able to travel to the handpiece and battery pack during use of the Strykeflow 2 Suction Irrigator. This design change has caused some devices to leak and/or emit vaporized saline (which can resemble smoke) during use.
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 medical procedure convenience kits labeled as: 1) LAPAROSCOPY CDS-LF, REF CDS860235L; 2) GENERAL LAPAROSCOPIC, REF CDS930223M; 3) LAP CHOLE CDS, REF CDS983678K; 4) LAPAROSCOPY PELV CDS, REF CDS983679K; 5) LAP CHOLE CDS-LF, REF CDS983752M; 6) LAP CHOLE CDS-LF, REF CDS984016B; 7) LAP CHOLE KIT, REF CDS984020P; 8) LAP CHOLE-LF, REF CDS984175J; 9) LAP COLON CDS, REF CDS984849N; 10) GENERAL LAPAROSCOPY CDS, REF CDS985328M; 11) LAP CHOLE, REF DYNJQ9044O; 12) GENERAL LAPAROSCOPY V, REF DYNJS2032F; 13) LAP CHOLE PACK, REF DYNJ26209R; 14) LAP CHOLE PACK, REF DYNJ26209S; 15) GENERAL LAPAROSCOPY PACK, REF DYNJ37459D; 16) DR. BROWN LAP CHOLE PLUS SETUP, REF DYNJ42578G; 17) LAPAROSCOPY GENERAL PACK, REF DYNJ45083G; 18) LAP CHOLE PACK, REF DYNJ51785D; 19) LAPAROSCOPY PACK, REF DYNJ61652A; 20) ENDOSCOPY, REF DYNJ62133A; 21) LAP CHOLE PACK, REF DYNJ66285A; 22) LAPAROSCOPY PACK, REF DYNJ66289B; 23) LAPAROSCOPIC CHOLECYSTECTO, REF DYNJ67296D; 24) LAPAROSCOPY PACK, REF DYNJ68187A; 25) LAP OB PACK, REF DYNJ68741A; 26) LAP CHOLE PACK-LF, REF DYNJ81408A; 27) LAP CHOLE PACK-LF, REF DYNJ81408B; 28) LAP CHOLE PACK, REF DYNJ85318; 29) GENERAL LAPAROSCOPY PACK, REF DYNJ89677; 30) LEX GENERAL LAPAROSCOPY, REF DYNJ900969J; 31) LAP CHOLE, REF DYNJ901126G; 32) BARIATRIC KIT, REF DYNJ901145I; 33) GENERAL LAPAROSCOPY SOMC-LF, REF DYNJ901164M; 34) LAP GASTRIC SLEEVE, REF DYNJ901504L; 35) GENERAL LAP GASTRIC, REF DYNJ901827X; 36) GENERAL LAPAROSCOPY, REF DYNJ901847N; 37) LOU LAP SIGMOID COLON, REF DYNJ901848L; 38) LAP CHOLE, REF DYNJ901870J; 39) LEX BARIATRIC, REF DYNJ902033L; 40) BARIATRIC, REF DYNJ902515K; 41) LAP CHOLE CDS, REF DYNJ902565K; 42) LAP CHOLE, REF DYNJ902995I; 43) LAP CHOLE, REF DYNJ903163L; 44) LAP APPY, REF DYNJ903164L; 45) GENERAL SURGERY LAPAROSCOPY, REF DYNJ903733C; 46) LAP CHOLE, REF DYNJ904693D; 47) BARIATRIC, REF DYNJ904891N; 48) LAPAROSCOPY, REF DYNJ905071F; 49) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390F; 50) KIT GENERAL LAPAROSCOPY MHS, REF DYNJ905390G; 51) KIT GENERAL LAPAROSCOPY WEILER, REF DYNJ905407D; 52) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413A; 53) KIT GENERAL LAP WAKEFIELD, REF DYNJ905413B; 54) LAP BARIATRIC, REF DYNJ905733K; 55) KIT LAPAROSCOPIC GASTRIC B, REF DYNJ905856A; 56) LAP CHOLE, REF DYNJ906277D; 57) LAP CHOLE RFD, REF DYNJ906302D; 58) KIT LAP COLON RFD, REF DYNJ906315D; 59) GASTRIC SLEEVE, REF DYNJ906355D; 60) PROSTATECTOMY LAP ROBOTIC, REF DYNJ906805C; 61) LAP ROBOTIC SURG ONCOLOGY, REF DYNJ906824C; 62) GEN BARIATRIC, REF DYNJ907639D; 63) LAP CHOLE, REF DYNJ908415B; 64) LAP CHOLE, REF DYNJ908415C; 65) LAPAROSCOPIC, REF DYNJ908569B; 66) ROBOTIC GASTRIC LAP SLEEVE-LF, REF DYNJ909119G; 67) LAPAROSCOPIC GASTRIC ADD ON, REF DYNJ909628A; 68) BARIATRIC CENTRASTATE, REF DYNJ909817A; 69) LAP GENERAL THEDA, REF DYNJ910050; 70) LAPAROSCOPIC CHOLE PACK, REF DYNJ910139A; 71) ROBOTIC THORACIC, REF DYNJ910386; 72) BARIATRIC, REF DYNJ911017.
Lot / code information
- REF
- CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit
- Lot #
- 25EMH913
- REF
- CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit
- Lot #
- 25EMC376
- REF
- CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit
- Lot #
- 25CMJ688
- REF
- CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit
- Lot #
- 25CME476
- REF
- CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit
- Lot #
- 25EBM987
- REF
- CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit
- Lot #
- 25CBT666
- REF
- CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit
- Lot #
- 25FBP815
- REF
- CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit
- Lot #
- 25EBN002
- REF
- CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit
- Lot #
- 25CBN212
- REF
- CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit
- Lot #
- 25FBN760
- REF
- CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit
- Lot #
- 25EBD329
- REF
- CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit
- Lot #
- 25DBN040
- REF
- CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit
- Lot #
- 25DBK313
- REF
- CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit
- Lot #
- 25CBE452
- REF
- CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit
- Lot #
- 25DMH793
- REF
- CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit
- Lot #
- 25DMC405
- REF
- CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit
- Lot #
- 25EBN676
- REF
- CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit
- Lot #
- 25DBO816
- REF
- CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit
- Lot #
- 25CBJ724
- REF
- CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit
- Lot #
- 25BBK265
- REF
- CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit
- Lot #
- 25EMG591
- REF
- CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit
- Lot #
- 25DMH851
- REF
- CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit
- Lot #
- 25CMH945
- REF
- CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit
- Lot #
- 25EBS490
- REF
- CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit
- Lot #
- 25EBI971
- REF
- CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit
- Lot #
- 25DBO242
- REF
- CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit
- Lot #
- 25CBO208
- REF
- CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit
- Lot #
- 25BDA838
- REF
- CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit
- Lot #
- 25BDA425
- REF
- CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit
- Lot #
- 25CBP120
- REF
- CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit
- Lot #
- 25BBN336
- REF
- DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit
- Lot #
- 25FBG772
- REF
- DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit
- Lot #
- 25EBG794
- REF
- DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit
- Lot #
- 25DBF556
- REF
- DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit
- Lot #
- 25CBQ563
- REF
- DYNJS2032F: UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit
- Lot #
- 25EDC051
- REF
- DYNJ26209R: UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit
- Lot #
- 25BMG526
- REF
- DYNJ26209S: UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit
- Lot #
- 25FMA594
- REF
- DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit
- Lot #
- 25EBD946
- REF
- DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit
- Lot #
- 25CBS951
- REF
- DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit
- Lot #
- 25EBH485
- REF
- DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit
- Lot #
- 25DBK606
- REF
- DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit
- Lot #
- 25CBN430
- REF
- DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit
- Lot #
- 25FBK260
- REF
- DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit
- Lot #
- 25EBH397
- REF
- DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit
- Lot #
- 25DBT090
- REF
- DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit
- Lot #
- 25FDA326
- REF
- DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit
- Lot #
- 25CDA693
- REF
- DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit
- Lot #
- 25EMF946
- REF
- DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit
- Lot #
- 25CMG793
- REF
- DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit
- Lot #
- 25FBI408
- REF
- DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit
- Lot #
- 25CBR811
- REF
- DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit
- Lot #
- 25BBR383
- REF
- DYNJ66285A: UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit
- Lot #
- 25DBG032
- REF
- DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit
- Lot #
- 25EBA558
- REF
- DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit
- Lot #
- 25DBC195
- REF
- DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit
- Lot #
- 25FBM369
- REF
- DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit
- Lot #
- 25DBF833
- REF
- DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit
- Lot #
- 25DBC575
- REF
- DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit
- Lot #
- 25CBI966
- REF
- DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit
- Lot #
- 25FMB779
- REF
- DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit
- Lot #
- 25DMD529
- REF
- DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit
- Lot #
- 25DMH940
- REF
- DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit
- Lot #
- 25BMH074
- REF
- DYNJ81408A: UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit
- Lot #
- 25CMB055
- REF
- DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit
- Lot #
- 25FMC540
- REF
- DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit
- Lot #
- 25CMG686
- REF
- DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit
- Lot #
- 25CMD691
- REF
- DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit
- Lot #
- 25EBL562
- REF
- DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit
- Lot #
- 25CBP974
- REF
- DYNJ89677: UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit
- Lot #
- 25CMF548
- REF
- DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit
- Lot #
- 25DBP346
- REF
- DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit
- Lot #
- 25CBH795
- REF
- DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit
- Lot #
- 25FBE871
- REF
- DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit
- Lot #
- 25EBG615
- REF
- DYNJ901145I: UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit
- Lot #
- 25EBH921
- REF
- DYNJ901164M: UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit
- Lot #
- 25DBR923
- REF
- DYNJ901504L: UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit
- Lot #
- 25CBH718
- REF
- DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit
- Lot #
- 25FDA155
- REF
- DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit
- Lot #
- 25EDA571
- REF
- DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit
- Lot #
- 25CDA197
- REF
- DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit
- Lot #
- 25FBG897
- REF
- DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit
- Lot #
- 25EBJ874
- REF
- DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit
- Lot #
- 25DBM222
- REF
- DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit
- Lot #
- 25FBH903
- REF
- DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit
- Lot #
- 25EBH888
- REF
- DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit
- Lot #
- 25EBV494
- REF
- DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit
- Lot #
- 25DBD971
- REF
- DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit
- Lot #
- 25EBQ971
- REF
- DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit
- Lot #
- 25CBR575
- REF
- DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit
- Lot #
- 25EBH883
- REF
- DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit
- Lot #
- 25DBC358
- REF
- DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit
- Lot #
- 25EMD967
- REF
- DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit
- Lot #
- 25DMG347
- REF
- DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit
- Lot #
- 25EMH930
- REF
- DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit
- Lot #
- 25DMB723
- REF
- DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit
- Lot #
- 25EME835
- REF
- DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit
- Lot #
- 25DMJ465
- REF
- DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit
- Lot #
- 25DMF401
- REF
- DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit
- Lot #
- 25BMJ071
- REF
- DYNJ903164L: UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit
- Lot #
- 25FMD784
- REF
- DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit
- Lot #
- 25FBC756
- REF
- DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit
- Lot #
- 25EBF091
- REF
- DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit
- Lot #
- 25HBJ124
- REF
- DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit
- Lot #
- 25FBF713
- REF
- DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit
- Lot #
- 25DBJ916
- REF
- DYNJ904891N: UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit
- Lot #
- 25DBM300
- REF
- DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit
- Lot #
- 25EBO479
- REF
- DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit
- Lot #
- 25DBF405
- REF
- DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit
- Lot #
- 25DBG629
- REF
- DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit
- Lot #
- 25EBN370
- REF
- DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit
- Lot #
- 25CBR398
- REF
- DYNJ905390G: UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit
- Lot #
- 25FBS728
- REF
- DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit
- Lot #
- 25EBI282
- REF
- DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit
- Lot #
- 25CBK566
- REF
- DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit
- Lot #
- 25EBK030
- REF
- DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit
- Lot #
- 25DBF506
- REF
- DYNJ905413B: UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit
- Lot #
- 25FBN971
- REF
- DYNJ905733K: UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit
- Lot #
- 25DMI831
- REF
- DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit
- Lot #
- 25FBL810
- REF
- DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit
- Lot #
- 25EBN681
- REF
- DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit
- Lot #
- 25CBT634
- REF
- DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit
- Lot #
- 25FMA366
- REF
- DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit
- Lot #
- 25EMB405
- REF
- DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit
- Lot #
- 25DMJ507
- REF
- DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit
- Lot #
- 25CMI539
- REF
- DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit
- Lot #
- 25CMD374
- REF
- DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit
- Lot #
- 25EBJ685
- REF
- DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit
- Lot #
- 25CBN214
- REF
- DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit
- Lot #
- 25EBP431
- REF
- DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit
- Lot #
- 25DBG969
- REF
- DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit
- Lot #
- 25CBD708
- REF
- DYNJ906355D: UDI/DI 10198459130496 (EA)40198459130497 (CS), Kit
- Lot #
- 25CBR473
- REF
- DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit
- Lot #
- 25EBO230
- REF
- DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit
- Lot #
- 25DBN709
- REF
- DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit
- Lot #
- 25CBF802
- REF
- DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit
- Lot #
- 25FBJ387
- REF
- DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit
- Lot #
- 25EBG494
- REF
- DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit
- Lot #
- 25DBF817
- REF
- DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit
- Lot #
- 25FBL808
- REF
- DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit
- Lot #
- 25EBO292
- REF
- DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit
- Lot #
- 25CBU472
- REF
- DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit
- Lot #
- 25CBF619
- REF
- DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit
- Lot #
- 25CLA613
- REF
- DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit
- Lot #
- 25BLA456
- REF
- DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit
- Lot #
- 25FLA028
- REF
- DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit
- Lot #
- 25ELA953
- REF
- DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit
- Lot #
- 25DLA736
- REF
- DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit
- Lot #
- 25EBK350
- REF
- DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit
- Lot #
- 25BBI977
- REF
- DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit
- Lot #
- 25FBP681
- REF
- DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit
- Lot #
- 25CBM187
- REF
- DYNJ909628A: UDI/DI 10198459013751 (EA)40198459013752 (CS), Kit
- Lot #
- 25EBB901
- REF
- DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit
- Lot #
- 25FBP547
- REF
- DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit
- Lot #
- 25FBG101
- REF
- DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit
- Lot #
- 25EBK620
- REF
- DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit
- Lot #
- 25EMA608
- REF
- DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit
- Lot #
- 25CMI012
- REF
- DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit
- Lot #
- 25FBU030
- REF
- DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit
- Lot #
- 25FBB531
- REF
- DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit
- Lot #
- 25DBO255
- REF
- DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit
- Lot #
- 25EMF578
- REF
- DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit
- Lot #
- 25DMG348
- REF
- DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit
- Lot #
- 25FBR251
- REF
- DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit
- Lot #
- 25FBE132
Show 320 more code fieldsShow fewer
What the firm is doing
Medline Industries issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 12/16/2025 via email and USPS first class mail. The notice explained the issue, potential risk, and requested the following: "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 quantityof affected product you have in inventory on the form. Even if you do not have any affected productin inventory, please complete and submit the form. Website link: https://recalls.medline.comRecall Reference #: R-25-145-FGX5 Recall Code: 3.Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove and discard the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable. 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 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-1086-2026
- FDA device classification · FDEOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.1500The 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.
More Class II recalls
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 Inc recalls Brand Name: Sterile Tourniquet Hoses Product Name: A.T.S¿ 4000 TS Tourniquet Systems D…
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
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