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: Lavh Procedure, 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-1089-2026
- 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
- Surgical Instruments
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) 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.
Where it was distributed
US Nationwide distribution.
Questions about this recall
Is Medline medical procedure convenience kits labeled as: Lavh Procedure recalled?
Yes. Medline Industries recalled Medline medical procedure convenience kits labeled as: Lavh Procedure on 16 Dec 2025. The recall is Class II and its status is Ongoing. Recall number Z-1089-2026.
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 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.
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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