Windstone Medical Packaging, Inc. recall records

36 reported ongoing

36 records in this archive. Latest source date Jul 29, 2026.

FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

Records and reported status

FDA device enforcement

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 Vist...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.

Official source for Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
FDA device enforcement

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 Vist...

Class IIReported ongoing

Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.

Official source for Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Official source for Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. ...
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Official source for Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tube...
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Official source for Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. P...
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Official source for Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes....
FDA device enforcement

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 IIReported ongoing

Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

Official source for Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. ...
FDA device enforcement

Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Class IIReported ongoing

Distribution: US: MA OUS: None

Official source for Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE,...
FDA device enforcement

Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Class IIReported ongoing

Distribution: US: MA OUS: None

Official source for Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue ...
FDA device enforcement

Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

Class IIReported ongoing

Distribution: US: MA OUS: None

Official source for Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, S...
FDA device enforcement

Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI ...

Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

Class IIReported ongoing

Distribution: Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA, CO, CT, FL, Guam, IN, NC, NJ, NV, OK PA, TN, TX, and WI. The country of Canada.

Official source for Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M ...
FDA device enforcement

Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Proced...

Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the dru...

Class IIReported ongoing

Distribution: US: PA, WA, FL, GA

Official source for Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions conve...

Reasons in these listed records

  • 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 ...
  • Due to convenience kits containing a kit component that is under a recall action for improper use.
  • Sterility assurance for saline included in surgical kits cannot be guaranteed.
  • Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

These examples come from this result page and are not a ranking of every recall reason.

Checking Windstone Medical Packaging, Inc.

Is there a recall on windstone medical packaging, inc. right now?

This archive contains 36 records, including 36 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product.

How do I check my package or product?

Compare the product, firm and lot, date, model or serial identifiers with the notice. Use the label-check guide if you need help locating an identifier.

Does a matching name mean every item is included?

A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall.

What if the search finds no matching record?

This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. Check source coverage and the agency's current notices.

Where can I find older records?

Use monthly archives or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page.

Keep checking