Windstone Medical Packaging, Inc. Recalls

12 recalls from federal safety databases (FDA, CPSC). Sourced directly from government enforcement feeds.

Medical Device Recalls (12)

March 11, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Class II
March 11, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Class II
March 11, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space Large Volume Pump, Outlook Pump and Vista Basic Pump due to potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers or other connections and the ability to prime (occlusion).
Class II
August 16, 2024
Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II
August 16, 2024
Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II
August 16, 2024
Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II
August 16, 2024
Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II
August 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a convenient manner for use in a general clinical procedure.
Due to convenience kits containing a kit component that is under a recall action for improper use.
Class II
December 22, 2023
Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Class I
December 22, 2023
Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Class I
December 22, 2023
Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Class I
December 22, 2023
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Sterility assurance for saline included in surgical kits cannot be guaranteed.
Class I

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.