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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 98197

6 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 16, 2025
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Medline Industries, LP

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

6 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 6

Medline medical procedure convenience kits labeled as: 1) THORACIC ROBOTICS, REF DYNJ908777B; 2) CARDIAC ROBOTIC WHC KIT-LF, REF DYNJ911359

Z-1085-2026
Recall number
Z-1085-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
96 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

1) UDI/DI 10198459269196 (EA) 40198459269197 (CS), Lot Number 25EBD732; 2) UDI/DI 10198459326318 (EA) 40198459326319 (CS), Lot Number 25FBA103.

Distribution pattern

US Nationwide distribution.

device · product 2 of 6

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.

Z-1086-2026
Recall number
Z-1086-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
41432 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMH913; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25EMC376; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CMJ688; REF CDS860235L: UDI/DI 10198459258664 (EA)40198459258665 (CS), Kit Lot Number 25CME476; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25EBM987; REF CDS930223M: UDI/DI 10198459282607 (EA)40198459282608 (CS), Kit Lot Number 25CBT666; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25FBP815; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25EBN002; REF CDS983678K: UDI/DI 10195327572242 (EA)40195327572243 (CS), Kit Lot Number 25CBN212; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25FBN760; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25EBD329; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBN040; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25DBK313; REF CDS983679K: UDI/DI 10195327641511 (EA)40195327641512 (CS), Kit Lot Number 25CBE452; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMH793; REF CDS983752M: UDI/DI 10195327255855 (EA)40195327255856 (CS), Kit Lot Number 25DMC405; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25EBN676; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25DBO816; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25CBJ724; REF CDS984016B: UDI/DI 10195327191078 (EA)40195327191079 (CS), Kit Lot Number 25BBK265; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25EMG591; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25DMH851; REF CDS984020P: UDI/DI 10198459134333 (EA)40198459134334 (CS), Kit Lot Number 25CMH945; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBS490; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25EBI971; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25DBO242; REF CDS984175J: UDI/DI 10198459138959 (EA)40198459138950 (CS), Kit Lot Number 25CBO208; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA838; REF CDS984849N: UDI/DI 10195327694210 (EA)40195327694211 (CS), Kit Lot Number 25BDA425; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25CBP120; REF CDS985328M: UDI/DI 10198459114564 (EA)40198459114565 (CS), Kit Lot Number 25BBN336; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25FBG772; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25EBG794; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25DBF556; REF DYNJQ9044O: UDI/DI 10198459043154 (EA)40198459043155 (CS), Kit Lot Number 25CBQ563; REF DYNJS2032F: UDI/DI 10198459023774 (EA)40198459023775 (CS), Kit Lot Number 25EDC051; REF DYNJ26209R: UDI/DI 10198459265167 (EA)40198459265168 (CS), Kit Lot Number 25BMG526; REF DYNJ26209S: UDI/DI 10198459352614 (EA)40198459352615 (CS), Kit Lot Number 25FMA594; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25EBD946; REF DYNJ37459D: UDI/DI 10193489692150 (EA)40193489692151 (CS), Kit Lot Number 25CBS951; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25EBH485; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25DBK606; REF DYNJ42578G: UDI/DI 10198459241611 (EA)40198459241612 (CS), Kit Lot Number 25CBN430; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25FBK260; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25EBH397; REF DYNJ45083G: UDI/DI 10195327045210 (EA)40195327045211 (CS), Kit Lot Number 25DBT090; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25FDA326; REF DYNJ51785D: UDI/DI 10198459136382 (EA)40198459136383 (CS), Kit Lot Number 25CDA693; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25EMF946; REF DYNJ61652A: UDI/DI 10193489468106 (EA)40193489468107 (CS), Kit Lot Number 25CMG793; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25FBI408; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25CBR811; REF DYNJ62133A: UDI/DI 10198459206641 (EA)40198459206642 (CS), Kit Lot Number 25BBR383; REF DYNJ66285A: UDI/DI 10193489428070 (EA)40193489428071 (CS), Kit Lot Number 25DBG032; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25EBA558; REF DYNJ66289B: UDI/DI 10193489950540 (EA)40193489950541 (CS), Kit Lot Number 25DBC195; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25FBM369; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBF833; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25DBC575; REF DYNJ67296D: UDI/DI 10195327668884 (EA)40195327668885 (CS), Kit Lot Number 25CBI966; REF DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25FMB779; REF DYNJ68187A: UDI/DI 10195327384494 (EA)40195327384495 (CS), Kit Lot Number 25DMD529; REF DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25DMH940; REF DYNJ68741A: UDI/DI 10195327404932 (EA)40195327404933 (CS), Kit Lot Number 25BMH074; REF DYNJ81408A: UDI/DI 10198459133947 (EA)40198459133948 (CS), Kit Lot Number 25CMB055; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25FMC540; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMG686; REF DYNJ81408B: UDI/DI 10198459291524 (EA)40198459291525 (CS), Kit Lot Number 25CMD691; REF DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25EBL562; REF DYNJ85318: UDI/DI 10195327488741 (EA)40195327488742 (CS), Kit Lot Number 25CBP974; REF DYNJ89677: UDI/DI 10198459281716 (EA)40198459281717 (CS), Kit Lot Number 25CMF548; REF DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25DBP346; REF DYNJ900969J: UDI/DI 10195327394608 (EA)40195327394609 (CS), Kit Lot Number 25CBH795; REF DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25FBE871; REF DYNJ901126G: UDI/DI 10198459149016 (EA)40198459149017 (CS), Kit Lot Number 25EBG615; REF DYNJ901145I: UDI/DI 10195327603960 (EA)40195327603961 (CS), Kit Lot Number 25EBH921; REF DYNJ901164M: UDI/DI 10195327468675 (EA)40195327468676 (CS), Kit Lot Number 25DBR923; REF DYNJ901504L: UDI/DI 10195327524456 (EA)40195327524457 (CS), Kit Lot Number 25CBH718; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25FDA155; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25EDA571; REF DYNJ901827X: UDI/DI 10198459231377 (EA)40198459231378 (CS), Kit Lot Number 25CDA197; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25FBG897; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25EBJ874; REF DYNJ901847N: UDI/DI 10198459288142 (EA)40198459288143 (CS), Kit Lot Number 25DBM222; REF DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25FBH903; REF DYNJ901848L: UDI/DI 10198459288166 (EA)40198459288167 (CS), Kit Lot Number 25EBH888; REF DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25EBV494; REF DYNJ901870J: UDI/DI 10198459288173 (EA)40198459288174 (CS), Kit Lot Number 25DBD971; REF DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25EBQ971; REF DYNJ902033L: UDI/DI 10195327388485 (EA)40195327388486 (CS), Kit Lot Number 25CBR575; REF DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25EBH883; REF DYNJ902515K: UDI/DI 10195327662608 (EA)40195327662609 (CS), Kit Lot Number 25DBC358; REF DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25EMD967; REF DYNJ902565K: UDI/DI 10198459176401 (EA)40198459176402 (CS), Kit Lot Number 25DMG347; REF DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25EMH930; REF DYNJ902995I: UDI/DI 10198459250194 (EA)40198459250195 (CS), Kit Lot Number 25DMB723; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25EME835; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMJ465; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25DMF401; REF DYNJ903163L: UDI/DI 10198459222733 (EA)40198459222734 (CS), Kit Lot Number 25BMJ071; REF DYNJ903164L: UDI/DI 10198459222740 (EA)40198459222741 (CS), Kit Lot Number 25FMD784; REF DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25FBC756; REF DYNJ903733C: UDI/DI 10195327550622 (EA)40195327550623 (CS), Kit Lot Number 25EBF091; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25HBJ124; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25FBF713; REF DYNJ904693D: UDI/DI 10198459230530 (EA)40198459230531 (CS), Kit Lot Number 25DBJ916; REF DYNJ904891N: UDI/DI 10198459071881 (EA)40198459071882 (CS), Kit Lot Number 25DBM300; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25EBO479; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBF405; REF DYNJ905071F: UDI/DI 10195327052386 (EA)40195327052387 (CS), Kit Lot Number 25DBG629; REF DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25EBN370; REF DYNJ905390F: UDI/DI 10195327048112 (EA)40195327048113 (CS), Kit Lot Number 25CBR398; REF DYNJ905390G: UDI/DI 10198459346309 (EA)40198459346300 (CS), Kit Lot Number 25FBS728; REF DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25EBI282; REF DYNJ905407D: UDI/DI 10198459131677 (EA)40198459131678 (CS), Kit Lot Number 25CBK566; REF DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25EBK030; REF DYNJ905413A: UDI/DI 10193489752021 (EA)40193489752022 (CS), Kit Lot Number 25DBF506; REF DYNJ905413B: UDI/DI 10198459346293 (EA)40198459346294 (CS), Kit Lot Number 25FBN971; REF DYNJ905733K: UDI/DI 10198459061493 (EA)40198459061494 (CS), Kit Lot Number 25DMI831; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25FBL810; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25EBN681; REF DYNJ905856A: UDI/DI 10195327282066 (EA)40195327282067 (CS), Kit Lot Number 25CBT634; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25FMA366; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25EMB405; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25DMJ507; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMI539; REF DYNJ906277D: UDI/DI 10198459117435 (EA)40198459117436 (CS), Kit Lot Number 25CMD374; REF DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25EBJ685; REF DYNJ906302D: UDI/DI 10198459080579 (EA)40198459080570 (CS), Kit Lot Number 25CBN214; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25EBP431; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25DBG969; REF DYNJ906315D: UDI/DI 10198459080456 (EA)40198459080457 (CS), Kit Lot Number 25CBD708; REF DYNJ906355D: UDI/DI 10198459130496 (EA)40198459130497 (CS), Kit Lot Number 25CBR473; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25EBO230; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25DBN709; REF DYNJ906805C: UDI/DI 10195327433734 (EA)40195327433735 (CS), Kit Lot Number 25CBF802; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25FBJ387; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25EBG494; REF DYNJ906824C: UDI/DI 10195327433598 (EA)40195327433599 (CS), Kit Lot Number 25DBF817; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25FBL808; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25EBO292; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBU472; REF DYNJ907639D: UDI/DI 10195327600860 (EA)40195327600861 (CS), Kit Lot Number 25CBF619; REF DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25CLA613; REF DYNJ908415B: UDI/DI 10195327624156 (EA)40195327624157 (CS), Kit Lot Number 25BLA456; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25FLA028; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25ELA953; REF DYNJ908415C: UDI/DI 10198459320507 (EA)40198459320508 (CS), Kit Lot Number 25DLA736; REF DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25EBK350; REF DYNJ908569B: UDI/DI 10195327591182 (EA)40195327591183 (CS), Kit Lot Number 25BBI977; REF DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25FBP681; REF DYNJ909119G: UDI/DI 10198459130526 (EA)40198459130527 (CS), Kit Lot Number 25CBM187; REF DYNJ909628A: UDI/DI 10198459013751 (EA)40198459013752 (CS), Kit Lot Number 25EBB901; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBP547; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25FBG101; REF DYNJ909817A: UDI/DI 10195327660628 (EA)40195327660629 (CS), Kit Lot Number 25EBK620; REF DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25EMA608; REF DYNJ910050: UDI/DI 10195327552657 (EA)40195327552658 (CS), Kit Lot Number 25CMI012; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBU030; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25FBB531; REF DYNJ910139A: UDI/DI 10198459129544 (EA)40198459129545 (CS), Kit Lot Number 25DBO255; REF DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25EMF578; REF DYNJ910386: UDI/DI 10195327661854 (EA)40195327661855 (CS), Kit Lot Number 25DMG348; REF DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBR251; REF DYNJ911017: UDI/DI 10198459234316 (EA)40198459234317 (CS), Kit Lot Number 25FBE132.

Distribution pattern

US Nationwide distribution.

device · product 3 of 6

Medline medical procedure convenience kits labeled as: 1) WCH BARI-GASTRECTOMY CDS, REF CDS860237AF; 2) ROBOTIC PROCEDURE, REF CDS982128Q; 3) CUH THORACIC, REF CDS984338M; 4) THORACIC PROCEDURE, REF CDS984640I; 5) DAVINCI ROBOTIC PACK-LF, REF DYNJ0525321O; 6) LAP CHOLE PACK, REF DYNJ57640F; 7) GYN/PROSTATE ROBOTIC PACK, REF DYNJ62594D; 8) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392D; 9) LAPAROSCOPY PACK, REF DYNJ68187B; 10) LAPAROSCOPY PACK, REF DYNJ82368A; 11) ROBOTIC KIDNEY PACK, REF DYNJ85261; 12) DOWNTOWN ROBOTICS, REF DYNJ86178B; 13) DAVINCI LITHOTOMY PACK, REF DYNJ87610; 14) ROBOTIC WHIPPLE PACK, REF DYNJ88433; 15) PROSTATE DAVINCI, REF DYNJ900127G; 16) GENERAL LAPAROSCOPY, REF DYNJ901847M; 17) LAG TLH, REF DYNJ901890N; 18) LITHOTOMY ROBOTIC CDS, REF DYNJ903948S; 19) LAP, REF DYNJ904576B; 20) ROBOTIC, REF DYNJ905147B; 21) ROBOTICS GYN, REF DYNJ905824M; 22) WH DAVINCI TLH PROCEDURE, REF DYNJ905920B; 23) CHN OR BASIC ROBOTIC, REF DYNJ905982I; 24) KIT ROBOTIC RFD, REF DYNJ906311F; 25) ROBOTIC PROSTATE, REF DYNJ906381G; 26) DAVINCI, REF DYNJ907392C; 27) CHIASSON GASTRIC SLEEVE KIT, REF DYNJ907405C; 28) GYN, REF DYNJ908504B; 29) UROLOGY ROBOTIC, REF DYNJ908588I; 30) THORACIC ROBOTICS, REF DYNJ908777A; 31) GENERAL ROBOT, REF DYNJ908969A; 32) KIT ROBOTIC, REF DYNJ909870B; 33) ROBOTIC THORACOSCOPY, REF DYNJ910924.

Z-1087-2026
Recall number
Z-1087-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
4536 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25FBK870; REF CDS860237AF: UDI/DI 10198459232626 (EA) 40198459232627 (CS), Lot Number 25EBD110; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25EBC253; REF CDS982128Q: UDI/DI 10198459008245 (EA) 40198459008246 (CS), Lot Number 25DBG393; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25FBQ303; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25EBD631; REF CDS984338M: UDI/DI 10198459148101 (EA) 40198459148102 (CS), Lot Number 25DBM322; REF CDS984640I: UDI/DI 10198459318955 (EA) 40198459318956 (CS), Lot Number 25DBT807; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25DMG099; REF DYNJ0525321O: UDI/DI 10198459236907 (EA) 40198459236908 (CS), Lot Number 25CMJ006; REF DYNJ57640F: UDI/DI 10198459011115 (EA) 40198459011116 (CS), Lot Number 25FDB347; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25EBK539; REF DYNJ62594D: UDI/DI 10198459049767 (EA) 40198459049768 (CS), Lot Number 25DBD145; REF DYNJ63392D: UDI/DI 10198459164507 (EA) 40198459164508 (CS), Lot Number 25BLA967; REF DYNJ68187B: UDI/DI 10198459382086 (EA) 40198459382087 (CS), Lot Number 25FMG440; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25EMH020; REF DYNJ82368A: UDI/DI 10198459258077 (EA) 40198459258078 (CS), Lot Number 25CMF917; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25FBK331; REF DYNJ85261: UDI/DI 10195327483418 (EA) 40195327483419 (CS), Lot Number 25EBR783; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBP320; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25EBC981; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25DBA834; REF DYNJ86178B: UDI/DI 10198459104800 (EA) 40198459104801 (CS), Lot Number 25CBM884; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25FBK123; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25EBF929; REF DYNJ87610: UDI/DI 10198459047817 (EA) 40198459047818 (CS), Lot Number 25CBT135; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25FMC215; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMF199; REF DYNJ88433: UDI/DI 10198459157936 (EA) 40198459157937 (CS), Lot Number 25EMC621; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25FBO994; REF DYNJ900127G: UDI/DI 10193489851588 (EA) 40193489851589 (CS), Lot Number 25EBE439; REF DYNJ901847M: UDI/DI 10198459037863 (EA) 40198459037864 (CS), Lot Number 25BBM364; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25FBJ408; REF DYNJ901890N: UDI/DI 10198459300592 (EA) 40198459300593 (CS), Lot Number 25EBJ877; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBO236; REF DYNJ903948S: UDI/DI 10198459332883 (EA) 40198459332884 (CS), Lot Number 25EBC133; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMH506; REF DYNJ904576B: UDI/DI 10888277776760 (EA) 40888277776761 (CS), Lot Number 25DMD329; REF DYNJ905147B: UDI/DI 10193489569032 (EA) 40193489569033 (CS), Lot Number 25GDB060; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25DMK337; REF DYNJ905824M: UDI/DI 10198459303272 (EA) 40198459303273 (CS), Lot Number 25CMF465; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25EBG945; REF DYNJ905920B: UDI/DI 10195327592707 (EA) 40195327592708 (CS), Lot Number 25CBM218; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25EMD118; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25DMJ823; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMJ265; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC374; REF DYNJ905982I: UDI/DI 10195327251420 (EA) 40195327251421 (CS), Lot Number 25CMC546; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25EBI860; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25DBR934; REF DYNJ906311F: UDI/DI 10198459080494 (EA) 40198459080495 (CS), Lot Number 25CBF096; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBJ655; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25FBE873; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25EBB258; REF DYNJ906381G: UDI/DI 10198459131066 (EA) 40198459131067 (CS), Lot Number 25DBR935; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25DMH137; REF DYNJ907392C: UDI/DI 10195327541378 (EA) 40195327541379 (CS), Lot Number 25CMJ730; REF DYNJ907405C: UDI/DI 10195327541392 (EA) 40195327541393 (CS), Lot Number 25CMF429; REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25FBG752; REF DYNJ908504B: UDI/DI 10198459318221 (EA) 40198459318222 (CS), Lot Number 25DBS537; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25FDA930; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDB953; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25EDA576; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25DDA437; REF DYNJ908588I: UDI/DI 10198459231544 (EA) 40198459231545 (CS), Lot Number 25CDB060; REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577; REF DYNJ908777A: UDI/DI 10195327415174 (EA) 40195327415175 (CS), Lot Number 25CBA577Z; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25EBI127; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBP413; REF DYNJ908969A: UDI/DI 10198459003950 (EA) 40198459003951 (CS), Lot Number 25CBD522; REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25EBF813; REF DYNJ909870B: UDI/DI 10198459122446 (EA) 40198459122447 (CS), Lot Number 25DBD407; REF DYNJ910924: UDI/DI 10198459203442 (EA) 40198459203443 (CS), Lot Number 25EBK656.

Distribution pattern

US Nationwide distribution.

device · product 4 of 6

Medline medical procedure convenience kits labeled as: 1) ROBOTIC, REF CDS980523M; 2) ROBOTIC GYN, REF CDS980647K; 3) DAVINCI PROCEDURE, REF CDS980864Q; 4) GYN-URO LAPSCP CDS-LF, REF CDS981583U; 5) GYN-URO LAPSCP CDS-LF, REF CDS981583V; 6) GYN ROBOTIC, REF CDS981826K; 7) DEPAUL DAVINCI CDS, REF CDS982377K; 8) GU DAVINCI, REF CDS982779N; 9) GYN DAVINCI, REF CDS982780V; 10) UNIVERSAL ROBOTIC ORLANDO, REF CDS982857K; 11) ROBOTIC GU/GYN, REF CDS983393L; 12) GYN LAPAROSCOPY CDS, REF CDS984656Q; 13) GYN LAPAROSCOPY CDS, REF CDS984656R; 14) DAVINCI CDS UCC-LF, REF CDS984663J; 15) ROBOTIC UROLOGY PROSTATE, REF CDS985467J; 16) DAVINCI PROSTATECTOMY, REF DYNJG901002B; 17) ROBOTIC PACK IMF 100913- LF, REF DYNJVB91075C; 18) ROBOTIC PACK, REF DYNJ36840L; 19) ROBOTIC PACK MNMC, REF DYNJ38152D; 20) WMC GYN LAPAROSCOPY PACK-LF, REF DYNJ50649J; 21) ROBOTIC GASTRIC BYPASS PACK, REF DYNJ52096P; 22) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564D; 23) SCRIPPS SW ROBOTIC PACK, REF DYNJ52564F; 24) GYN ROBOTIC PACK, REF DYNJ52581D; 25) GYN LAPAROSCOPY PACK, REF DYNJ53782J; 26) UNIVERSAL DAVINCI ROBOTIC P, REF DYNJ53968P; 27) WALKER GYN-UROLOGY ROBOTIC PK, REF DYNJ57458B; 28) GYN LAPAROSCOPY, REF DYNJ62136B; 29) RR-DAVINCI PROSTATE ACCESSORY, REF DYNJ63392F; 30) TOTAL LAPAROSCOPIC HYST PACK, REF DYNJ63456B; 31) ROBOTIC PACK, REF DYNJ67177D; 32) MH GYN LAPAROSCOPY PACK-LF, REF DYNJ84433B; 33) DAVINCI, REF DYNJ900963M; 34) LEX DAVINCI GYN MAJOR, REF DYNJ900965N; 35) LEX DAVINCI UROLOGY, REF DYNJ900967N; 36) COR DAVINCI, REF DYNJ901018O; 37) GYN ROBOTIC, REF DYNJ901046M; 38) DAVINCI, REF DYNJ901076L; 39) GYN ROBOTIC, REF DYNJ901796K; 40) LOU GENERAL ROBOT, REF DYNJ901844N; 41) LOU GYN LAPAROSCOPY, REF DYNJ901845L; 42) LOU GYN LAPAROSCOPY, REF DYNJ901845M; 43) LOU LITHOTOMY ROBOTIC, REF DYNJ901850N; 44) LEX GYN MINOR LAPAROSCOPY, REF DYNJ902029G; 45) GYN ROBOT, REF DYNJ902513J; 46) CHN OR DAVINCI PROSTATE, REF DYNJ902540O; 47) WMC ROBOTIC PACK - LF, REF DYNJ902583N; 48) ROBOTIC GYN & GU, REF DYNJ903459J; 49) GYN LAPAROSCOPY-LF, REF DYNJ903647I; 50) ROBOTIC UROLOGY, REF DYNJ903827F; 51) LITHOTOMY ROBOTIC CDS, REF DYNJ903948R; 52) GYN ROBOTIC, REF DYNJ903983P; 53) GYN LAP, REF DYNJ903990Q; 54) ROBOTIC-LF, REF DYNJ904254L; 55) ROBOTIC, REF DYNJ904343G; 56) ROBOT GYN, REF DYNJ904572L; 57) ROBOTIC PROSTECTOMY, REF DYNJ904597G; 58) GYN LAPAROSCOPY-LF, REF DYNJ905289G; 59) GYN ROBOTIC, REF DYNJ905730J; 60) URO ROBOTIC, REF DYNJ905746J; 61) COLON KIT, REF DYNJ905964G; 62) CHN OR ROBOTIC GYN, REF DYNJ905985O; 63) CW ROBOT, REF DYNJ906051C; 64) CW ROBOT, REF DYNJ906051D; 65) ROBOT, REF DYNJ906112B; 66) CDS ROBOTIC GYN CH, REF DYNJ906265D; 67) ROBOTIC GYN PACK, REF DYNJ906265F; 68) KIT GYN LAPAROSCOPY RFD, REF DYNJ906322F; 69) GYN LAPAROSCOPY, REF DYNJ906357C; 70) ROBOTIC COLON, REF DYNJ906379D; 71) GYN DAVINCI FOAKS, REF DYNJ906444C; 72) DAVINCI, REF DYNJ906543B; 73) CHN GYN ONCOLOGY, REF DYNJ906731K; 74) CHN ROBOTIC CYSTECTOMY, REF DYNJ907072F; 75) WMC THORACIC ROBOTIC, REF DYNJ907153C; 76) WMC THORACIC ROBOTIC, REF DYNJ907153D; 77) GYN ROBOTIC, REF DYNJ907492F; 78) KIT LAP GYN NTX, REF DYNJ907599C; 79) KIT ROBOTIC GYN, REF DYNJ907635D; 80) KIT ROBOTIC GYN, REF DYNJ907647B; 81) ROBOTIC-LF, REF DYNJ907910F; 82) ROBOTIC GENERAL, REF DYNJ907919C; 83) ROBOTIC BASE, REF DYNJ908447D; 84) ROBOTIC BASE, REF DYNJ908447F; 85) GYN, REF DYNJ908504A; 86) GU DAVINCI KIT, REF DYNJ908783F; 87) ROBOTIC PROSTATE, REF DYNJ909120D; 88) OSC ROBOT BARIATRIC, REF DYNJ909547; 89) LEX DAVINCI PROSTATE, REF DYNJ909548A; 90) GYN-URO ROBOT, REF DYNJ910137A; 91) PROSTATECTOMY ROBOTIC, REF DYNJ910991; 92) GYN ROBOTIC, REF DYNJ910995; 93) ROBOTIC, REF DYNJ9225761X; 94) DAVINCI ROBOTIC PACK-LF, REF DYNJ9288198X; 95) MB GYN ROBOTIC ADD, REF DYNJ9701096M; 96) PHS722500FCK, REF PHS722500G.

Z-1088-2026
Recall number
Z-1088-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
12584 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25FBF036; REF CDS980523M: UDI/DI 10195327508913 (EA) 40195327508914 (CS), Lot number 25DBB218; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25DBP829; REF CDS980647K: UDI/DI 10195327508920 (EA) 40195327508921 (CS), Lot number 25CBI860; REF CDS980864Q: UDI/DI 10198459121937 (EA) 40198459121938 (CS), Lot number 25EMC533; REF CDS981583U: UDI/DI 10195327209766 (EA) 40195327209767 (CS), Lot number 25CBC570; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25FBK816; REF CDS981583V: UDI/DI 10198459311390 (EA) 40198459311391 (CS), Lot number 25EBS462; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25FBH633; REF CDS981826K: UDI/DI 10198459224805 (EA) 40198459224806 (CS), Lot number 25BBU420; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMI839; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25DMF861; REF CDS982377K: UDI/DI 10198459229039 (EA) 40198459229030 (CS), Lot number 25CMC823; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25EBF365; REF CDS982779N: UDI/DI 10195327647711 (EA) 40195327647712 (CS), Lot number 25CBM352; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25EBI642; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25DBP916; REF CDS982780V: UDI/DI 10195327647728 (EA) 40195327647729 (CS), Lot number 25CBT429; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25FBR222; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25EBJ713; REF CDS982857K: UDI/DI 10193489927863 (EA) 40193489927864 (CS), Lot number 25CBH758; REF CDS983393L: UDI/DI 10198459224614 (EA) 40198459224615 (CS), Lot number 25EBP657; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25CMG731; REF CDS984656Q: UDI/DI 10198459107368 (EA) 40198459107369 (CS), Lot number 25BME966; REF CDS984656R: UDI/DI 10198459312113 (EA) 40198459312114 (CS), Lot number 25DMI408; REF CDS984663J: UDI/DI 10198459019418 (EA) 40198459019419 (CS), Lot number 25CBM414; REF CDS985467J: UDI/DI 10195327689124 (EA) 40195327689125 (CS), Lot number 25BMF759; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25FLA112; REF DYNJG901002B: UDI/DI 10195327677145 (EA) 40195327677146 (CS), Lot number 25ELA210; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA810; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25ELA007; REF DYNJVB91075C: UDI/DI 10195327543693 (EA) 40195327543694 (CS), Lot number 25DLA059; REF DYNJ36840L: UDI/DI 10198459331923 (EA) 40198459331924 (CS), Lot number 25EBB131; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25FLA334; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25DLA454; REF DYNJ38152D: UDI/DI 10195327500993 (EA) 40195327500994 (CS), Lot number 25CLA543; REF DYNJ50649J: UDI/DI 10195327261504 (EA) 40195327261505 (CS), Lot number 25CBT190; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25FDA204; REF DYNJ52096P: UDI/DI 10198459140778 (EA) 40198459140779 (CS), Lot number 25DDB877; REF DYNJ52564D: UDI/DI 10195327176426 (EA) 40195327176427 (CS), Lot number 25BMF583; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMD560; REF DYNJ52564F: UDI/DI 10198459314162 (EA) 40198459314163 (CS), Lot number 25FMI642; REF DYNJ52581D: UDI/DI 10195327213886 (EA) 40195327213887 (CS), Lot number 25DMB242; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25EMI041; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25DMG684; REF DYNJ53782J: UDI/DI 10195327545093 (EA) 40195327545094 (CS), Lot number 25CMD347; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25FMD297; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMH371; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25DMA836; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMH615; REF DYNJ53968P: UDI/DI 10195327532758 (EA) 40195327532759 (CS), Lot number 25CMA935; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25FBD162; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBV003; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBO450; REF DYNJ57458B: UDI/DI 10198459303753 (EA) 40198459303754 (CS), Lot number 25DBB005; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBS192; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25FBB252; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBU301; REF DYNJ62136B: UDI/DI 10198459206672 (EA) 40198459206673 (CS), Lot number 25DBB429; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25FLA272; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25ELA626; REF DYNJ63392F: UDI/DI 10198459315572 (EA) 40198459315573 (CS), Lot number 25DLA944; REF DYNJ63456B: UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25FBO125; REF DYNJ63456B: UDI/DI 10193489956504 (EA) 40193489956505 (CS), Lot number 25DBK731; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD264; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25FBD519; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25EBE408; REF DYNJ67177D: UDI/DI 10195327669768 (EA) 40195327669769 (CS), Lot number 25DBC173; REF DYNJ84433B: UDI/DI 10198459113598 (EA) 40198459113599 (CS), Lot number 25EBD020; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25FBC396; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25DBC417; REF DYNJ900963M: UDI/DI 10198459153426 (EA) 40198459153427 (CS), Lot number 25BBU398; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25FBN962; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBP344; REF DYNJ900965N: UDI/DI 10195327504991 (EA) 40195327504992 (CS), Lot number 25DBC207; REF DYNJ900967N: UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25EBV490; REF DYNJ900967N: UDI/DI 10195327504984 (EA) 40195327504985 (CS), Lot number 25DBC354; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25FBJ418; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25EBK336; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25DBV042; REF DYNJ901018O: UDI/DI 10195327474881 (EA) 40195327474882 (CS), Lot number 25CBL781; REF DYNJ901046M: UDI/DI 10198459130380 (EA) 40198459130381 (CS), Lot number 25FBM810; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMJ099; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMG577; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD806; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25EMD755; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25DMB047; REF DYNJ901076L: UDI/DI 10198459258008 (EA) 40198459258009 (CS), Lot number 25CMI669; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMI909; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EME506; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25EMA622; REF DYNJ901796K: UDI/DI 10193489979701 (EA) 40193489979702 (CS), Lot number 25CME376; REF DYNJ901844N: UDI/DI 10195327620981 (EA) 40195327620982 (CS), Lot number 25DBE209; REF DYNJ901845L: UDI/DI 10195327579197 (EA) 40195327579198 (CS), Lot number 25CBC628; REF DYNJ901845M: UDI/DI 10198459288159 (EA) 40198459288150 (CS), Lot number 25EBS830; REF DYNJ901850N: UDI/DI 10195327620998 (EA) 40195327620999 (CS), Lot number 25DBE377; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBR019; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25DBH434; REF DYNJ902029G: UDI/DI 10195327391256 (EA) 40195327391257 (CS), Lot number 25CBO260; REF DYNJ902513J: UDI/DI 10195327662745 (EA) 40195327662746 (CS), Lot number 25EBO161; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25ELA305; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25DLA166; REF DYNJ902540O: UDI/DI 10198459192265 (EA) 40198459192266 (CS), Lot number 25CLA999; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25FBM125; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25DBD973; REF DYNJ902583N: UDI/DI 10198459024764 (EA) 40198459024765 (CS), Lot number 25BBT778; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25FBB837; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25DBV160; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBK831; REF DYNJ903459J: UDI/DI 10198459258473 (EA) 40198459258474 (CS), Lot number 25CBH604; REF DYNJ903647I: UDI/DI 10198459016820 (EA) 40198459016821 (CS), Lot number 25EBK700; REF DYNJ903827F: UDI/DI 10198459184901 (EA) 40198459184902 (CS), Lot number 25DMJ677; REF DYNJ903948R: UDI/DI 10198459104411 (EA) 40198459104412 (CS), Lot number 25CBL682; REF DYNJ903983P: UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25FDB185; REF DYNJ903983P: UDI/DI 10198459231216 (EA) 40198459231217 (CS), Lot number 25DDA847; REF DYNJ903990Q: UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25FDB213; REF DYNJ903990Q: UDI/DI 10198459231261 (EA) 40198459231262 (CS), Lot number 25BDB159; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25FBK097; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25EBN006; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBR174; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25DBB130; REF DYNJ904254L: UDI/DI 10198459125584 (EA) 40198459125585 (CS), Lot number 25CBC542; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25FBJ386; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25EBG616; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBT550; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBO348; REF DYNJ904343G: UDI/DI 10198459079054 (EA) 40198459079055 (CS), Lot number 25CBD568; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBT946; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBN312; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25EBM906; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBO254; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25CBH661; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBR098; REF DYNJ904572L: UDI/DI 10198459254802 (EA) 40198459254803 (CS), Lot number 25BBJ047; REF DYNJ904597G: UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25DMB367; REF DYNJ904597G: UDI/DI 10195327547493 (EA) 40195327547494 (CS), Lot number 25BMF447; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25FBM315; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25DBB336; REF DYNJ905289G: UDI/DI 10195327392987 (EA) 40195327392988 (CS), Lot number 25CBC157; REF DYNJ905730J: UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DMI347; REF DYNJ905730J: UDI/DI 10198459061462 (EA) 40198459061463 (CS), Lot number 25DME212; REF DYNJ905746J: UDI/DI 10198459061455 (EA) 40198459061456 (CS), Lot number 25DMI830; REF DYNJ905964G: UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25FBQ752; REF DYNJ905964G: UDI/DI 10198459156830 (EA) 40198459156831 (CS), Lot number 25CBO349; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25EDB456; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25CDB971; REF DYNJ905985O: UDI/DI 10195327697693 (EA) 40195327697694 (CS), Lot number 25BDB112; REF DYNJ906051C: UDI/DI 10195327343392 (EA) 40195327343393 (CS), Lot number 25CBJ023; REF DYNJ906051D: UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBH988; REF DYNJ906051D: UDI/DI 10198459287527 (EA) 40198459287528 (CS), Lot number 25DBE149; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25FBN075; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBT833; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25EBM894; REF DYNJ906112B: UDI/DI 10195327597375 (EA) 40195327597376 (CS), Lot number 25DBG798; REF DYNJ906265D: UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25DBB516; REF DYNJ906265D: UDI/DI 10195327456764 (EA) 40195327456765 (CS), Lot number 25CBK354; REF DYNJ906265F: UDI/DI 10198459339806 (EA) 40198459339807 (CS), Lot number 25FBI618; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25FBH720; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25EBF411; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBD977; REF DYNJ906322F: UDI/DI 10198459080562 (EA) 40198459080563 (CS), Lot number 25DBB800; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25FBD902; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25EBN653; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25DBG849; REF DYNJ906357C: UDI/DI 10193489867985 (EA) 40193489867986 (CS), Lot number 25CBE442; REF DYNJ906379D: UDI/DI 10198459131035 (EA) 40198459131036 (CS), Lot number 25FBK055; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25EBL655; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25DBA252; REF DYNJ906444C: UDI/DI 10195327362690 (EA) 40195327362691 (CS), Lot number 25CBJ638; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25EBP621; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25DBA268; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBN673; REF DYNJ906543B: UDI/DI 10198459026164 (EA) 40198459026165 (CS), Lot number 25CBE740; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25FDA837; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25EDB457; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25CDA446; REF DYNJ906731K: UDI/DI 10195327436346 (EA) 40195327436347 (CS), Lot number 25BDB494; REF DYNJ907072F: UDI/DI 10195327498481 (EA) 40195327498482 (CS), Lot number 25FLA043; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25DBG686; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBR320; REF DYNJ907153C: UDI/DI 10195327600778 (EA) 40195327600779 (CS), Lot number 25CBB606; REF DYNJ907153D: UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBT961; REF DYNJ907153D: UDI/DI 10198459333606 (EA) 40198459333607 (CS), Lot number 25EBB608; REF DYNJ907492F: UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25CMH362; REF DYNJ907492F: UDI/DI 10195327389789 (EA) 40195327389780 (CS), Lot number 25BMI302; REF DYNJ907599C: UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25FBD904; REF DYNJ907599C: UDI/DI 10195327342593 (EA) 40195327342594 (CS), Lot number 25DBH124; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25EBT433; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBL490; REF DYNJ907635D: UDI/DI 10198459240690 (EA) 40198459240691 (CS), Lot number 25DBG765; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBR238; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25EBA853; REF DYNJ907647B: UDI/DI 10195327409142 (EA) 40195327409143 (CS), Lot number 25CBQ766; REF DYNJ907910F: UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBL209; REF DYNJ907910F: UDI/DI 10198459253225 (EA) 40198459253226 (CS), Lot number 25FBE603; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25EMH024; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMG480; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMC385; REF DYNJ907919C: UDI/DI 10195327270193 (EA) 40195327270194 (CS), Lot number 25CMB958; REF DYNJ908447D: UDI/DI 10195327610753 (EA) 40195327610754 (CS), Lot number 25CBA952; REF DYNJ908447F: UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25FBM340; REF DYNJ908447F: UDI/DI 10198459301063 (EA) 40198459301064 (CS), Lot number 25EBE460; REF DYNJ908504A: UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBP390; REF DYNJ908504A: UDI/DI 10195327251291 (EA) 40195327251292 (CS), Lot number 25CBK432; REF DYNJ908783F: UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25DMC328; REF DYNJ908783F: UDI/DI 10198459100895 (EA) 40198459100896 (CS), Lot number 25CMG289; REF DYNJ909120D: UDI/DI 10198459130540 (EA) 40198459130541 (CS), Lot number 25DBJ949; REF DYNJ909547: UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25CBP409; REF DYNJ909547: UDI/DI 10195327395896 (EA) 40195327395897 (CS), Lot number 25BBH373; REF DYNJ909548A: UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25FBN965; REF DYNJ909548A: UDI/DI 10195327538309 (EA) 40195327538300 (CS), Lot number 25EBH875; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25FBE605; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25EBD597; REF DYNJ910137A: UDI/DI 10198459201561 (EA) 40198459201562 (CS), Lot number 25DBD951; REF DYNJ910991: UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25EMH063; REF DYNJ910991: UDI/DI 10198459242045 (EA) 40198459242046 (CS), Lot number 25DMC222; REF DYNJ910995: UDI/DI 10198459242038 (EA) 40198459242039 (CS), Lot number 25CMH628; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25FMB646; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25DMA960; REF DYNJ9225761X: UDI/DI 10195327587475 (EA) 40195327587476 (CS), Lot number 25CMB504; REF DYNJ9288198X: UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25EME557; REF DYNJ9288198X: UDI/DI 10198459133886 (EA) 40198459133887 (CS), Lot number 25DMG373; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25EMH286; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMH432; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25DMA405; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BMI178; REF DYNJ9701096M: UDI/DI 10195327587659 (EA) 40195327587650 (CS), Lot number 25BME871; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25EMD105; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25CMH699; REF PHS722500G: UDI/DI 10198459009464 (EA) 40198459009465 (CS), Lot number 25BMI579.

Distribution pattern

US Nationwide distribution.

device · product 5 of 6

Medline medical procedure convenience kits labeled as: 1) LAVH PROCEDURE, REF CDS980754T; 2) GYN LAP HYSTERECTOMY CDS, REF CDS982662Q; 3) DAVINCI HYSTERECTOMY CDS, REF CDS985344F; 4) LAVH, REF DYNJQ9041R; 5) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ900244I; 6) ROBOTIC LAVH, REF DYNJ901281I; 7) LAVH-LF, REF DYNJ901829T; 8) LEX LAP HYST, REF DYNJ902030J; 9) LITHOTOMY-SLINGS-LF, REF DYNJ905274D; 10) GYN LAPAROSCOPY, REF DYNJ905485J; 11) ROBOTIC HYSTERECTOMY, REF DYNJ906380C; 12) LAPAROSCOPIC HYSTERECTOMY, REF DYNJ910634; 13) LAVH GYN/ONC, REF DYNJ910927.

Z-1089-2026
Recall number
Z-1089-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
1457 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

REF CDS980754T: UDI/DI 10198459121814 (EA) 40198459121815 (CS), Lot Number 25EMD795; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBR237; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25EBP591; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25DBM353; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25CBL184; REF CDS982662Q: UDI/DI 10195327306793 (EA) 40195327306794 (CS), Lot Number 25BBL633; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25FBK918; REF CDS985344F: UDI/DI 10195327312565 (EA) 40195327312566 (CS), Lot Number 25CBJ496; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25FBF371; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25EBK493; REF DYNJQ9041R: UDI/DI 10198459043086 (EA) 40198459043087 (CS), Lot Number 25DBH895; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25DBC272; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBU642; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25CBJ298; REF DYNJ900244I: UDI/DI 10195327464929 (EA) 40195327464920 (CS), Lot Number 25BBU206; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25FBA261; REF DYNJ901281I: UDI/DI 10195327699154 (EA) 40195327699155 (CS), Lot Number 25CBN230; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25FDB398; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25DDA191; REF DYNJ901829T: UDI/DI 10198459231384 (EA) 40198459231385 (CS), Lot Number 25BDB095; REF DYNJ902030J: UDI/DI 10195327391249 (EA) 40195327391240 (CS), Lot Number 25DBJ371; REF DYNJ905274D: UDI/DI 10195327393014 (EA) 40195327393015 (CS), Lot Number 25BBS130; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25FBJ689; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25EBP700; REF DYNJ905485J: UDI/DI 10198459202025 (EA) 40198459202026 (CS), Lot Number 25DBG283; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBJ430; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25FBC561; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBK650; REF DYNJ906380C: UDI/DI 10198459131042 (EA) 40198459131043 (CS), Lot Number 25EBE453; REF DYNJ910634: UDI/DI 10198459050398 (EA) 40198459050399 (CS), Lot Number 25CBS527; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25FMC511; REF DYNJ910927: UDI/DI 10198459204326 (EA) 40198459204327 (CS), Lot Number 25CMJ281.

Distribution pattern

US Nationwide distribution.

device · product 6 of 6

Medline medical procedure convenience kits labeled as: KIT ROBOTICS UROLOGY PROSTATE, REF DYKMBNDL116G

Z-1090-2026
Recall number
Z-1090-2026
Initiated
December 16, 2025
Classification
Class II
Status
Ongoing
Recalling firm
Medline Industries, LP
Quantity
12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

UDI/DI 10198459156991 (EA) 40198459156992 (CS), Lot Number 25EBM426

Distribution pattern

US Nationwide distribution.

Field note

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