FDA recall record · openFDA

Windstone Medical Packaging, Inc.

17 FDA recalls on record (2023–2026) — 17 device. 17 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Due to convenience kits containing a kit component that is under a recall action for improper use. 5

Sterility assurance for saline included in surgical kits cannot be guaranteed. 4

The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity 3

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedur 3

Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotatin 1

Recalls

Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S Class I 2026-04-02 Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO Class I 2023-12-22 Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO Class I 2023-12-22 Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO Class I 2023-12-22 Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO Class I 2023-12-22 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 Class II 2026-03-11 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A Class II 2026-03-11 Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 Class II 2026-03-11 Aligned Medical AMS16835 Fluids Kit RX Class II 2026-04-27 Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a Class II 2024-08-16 Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in Class II 2024-08-16 Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in Class II 2024-08-16 Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in Class II 2024-08-16 Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged Class II 2024-08-16 Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO Class II 2023-04-24 Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO Class II 2023-04-24 Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO Class II 2023-04-24

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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