CLASS II ONGOING Device recall · Reported 21 Jan 2026 · FDA Enforcement Report
Medline medical procedure convenience kits labeled as recalled
Medline Industries is recalling Medline medical procedure convenience kits labeled as: WCH Bari-gastrectomy CDS, distributed nationwide in the US. The recall was initiated on 16 Dec 2025 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1087-2026
- FDA event ID
- 98197
- Recalling firm
- Medline Industries, Northfield, IL
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 16 Dec 2025
- FDA classified
- 14 Jan 2026
- Reported
- 21 Jan 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Hip & Knee Implants
Timeline
| 16 Dec 2025 | Recall initiated by company | |
| 14 Jan 2026 | Classified by FDA | +29 days |
| 21 Jan 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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.
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 98197This product is part of a recall event; the main page for the event is Medline medical procedure convenience kits labeled as recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as recalled | Medline Industries | Packaging Defects | Nationwide | |
| CLASS II | Medline medical procedure convenience kits labeled as: Robotic recalled | Medline Industries | Packaging Defects | Nationwide |
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|---|---|---|---|---|---|
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Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |