CLASS II ONGOING Device recall · Reported 10 Jun 2026 · FDA Enforcement Report
Aligned Medical AMS16835 Fluids Kit RX recalled
Windstone Medical Packaging is recalling Aligned Medical AMS16835 Fluids Kit RX, distributed nationwide in the US. The recall was initiated on 27 Apr 2026 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-2307-2026
- FDA event ID
- 98957
- Recalling firm
- Windstone Medical Packaging, Billings, MT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 27 Apr 2026
- FDA classified
- 3 Jun 2026
- Reported
- 10 Jun 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 27 Apr 2026 | Recall initiated by company | |
| 3 Jun 2026 | Classified by FDA | +37 days |
| 10 Jun 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
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Product as listed by the FDA
Aligned Medical AMS16835 Fluids Kit RX
Where it was distributed
US Nationwide distribution in the states of IL, VA.
Questions about this recall
Why was it recalled?
Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
Which lots are affected?
UDI-DI: B098AMS168350; Lot Numbers: 233828, 236048, 236359, 236662, 238580, 239934, 239935
Where was it sold?
US Nationwide distribution in the states of IL, VA.
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.
More recalls from Windstone Medical Packaging
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|---|---|---|---|---|---|
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Sterility | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
| Device | CLASS II | Ams Aligned Medical Solutions medical convenience kits recalled | Windstone Medical Packaging | Packaging Defects | Nationwide |
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