Aligned Medical AMS16835 Fluids Kit Recall
Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.
Windstone Medical Packaging, Inc. is recalling 875 Aligned Medical AMS16835 Fluids Kits distributed in IL and VA because they contain lidocaine recalled by a supplier for quality issues.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on July 11, 2026 and geographically references Illinois, Virginia. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Devices.
What Happened
Windstone Medical Packaging, Inc. initiated a voluntary recall of the Aligned Medical AMS16835 Fluids Kit RX after learning that Lidocaine Hydrochloride Injection, USP, included in the kits was recalled by a supplier for quality issues.
Which Products Are Affected
The recall covers 875 kits of Aligned Medical AMS16835 Fluids Kit RX with UDI-DI B098AMS168350 and lot numbers 233828, 236048, 236359, 236662, 238580, 239934, and 239935. The kits were distributed nationwide in the states of IL and VA. The recall number is Z-2307-2026 and the classification is Class II.
What You Should Do
Consumers and healthcare facilities should check inventory for the affected lots and contact Windstone Medical Packaging, Inc. for return or refund instructions.
Why This Matters
The inclusion of the supplier-recalled lidocaine in these custom convenience kits creates a potential quality concern for users of the devices.
Source
FDA recall Z-2307-2026 (report date 20260610)
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (997 characters here).
Similar severity timing
Same severity (medium) notices issued closest in time to July 11, 2026.
Frequently Asked Questions
Common questions about this FDA recall.