Food, drugs, devices › Windstone Medical Packaging, Inc.
Device recall: Aligned Medical AMS16835 Fluids Kit RX
FDA enforcement event 98957 is a device recall by Windstone Medical Packaging, Inc. of Billings, MT, initiated 27 Apr 2026 and classified Class II, with 1 product record.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 87% of the 572 device enforcement events initiated in 2026 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Windstone Medical Packaging, Inc. has 20 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Windstone Medical Packaging, Inc., Billings, MT.
Reason for recall
"Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits."
Distribution
"US Nationwide distribution in the states of IL, VA."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2307-2026 | Aligned Medical AMS16835 Fluids Kit RX | 875 kits | Class II | Ongoing | 10 Jun 2026 |
Context
Other enforcement events for Windstone Medical Packaging, Inc.
All 20 events for Windstone Medical Packaging, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution in the states of IL, VA."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.