Recall archive
19 recalls · page 1 of 1
Reported Sep 16, 2026
AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand — The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts…
FDA (weekly enforcement report)
Reported Aug 5, 2026
AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details · Reason for recall — The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed¿ Neurological Sponges…
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 8, 2026
A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis)…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 10, 2026
Aligned Medical AMS16835 Fluids Kit RX
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
FDA (openFDA device enforcement)
Reported May 20, 2026
Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Brand — Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during…
FDA (openFDA device enforcement)
Reported Apr 29, 2026
Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Reason for recall — The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 16, 2024
Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Due to convenience kits containing a kit component that is under a recall action for improper use.
4 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 28, 2024
Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Sterility assurance for saline included in surgical kits cannot be guaranteed.
3 more products in this recall
FDA (openFDA device enforcement)
Reported May 31, 2023
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — 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…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jan 11, 2023
Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product details — Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
FDA (openFDA device enforcement)
Reported May 25, 2022
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug…
FDA (openFDA device enforcement)
Reported Nov 10, 2021
Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical…
High riskUsing this product could cause serious injury, illness or death — stop using it now.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air…
FDA (openFDA device enforcement)
Reported Jun 23, 2021
Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand — Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 15, 2017
AMS, ALIGNED MEDICAL SOLUTIONS, T&A Pack, AMS6357, STERILE EO.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Product · Product details — Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential…
FDA (openFDA device enforcement)
Reported Apr 19, 2017
Cataract Kit, part numbers CAT1467AM and CAT1538(B. Product packaged in a convenient manner for use in a general…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Reason for recall — AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be…
17 more products in this recall
FDA (openFDA device enforcement)
Reported Mar 8, 2017
Abdominoplasty Pack, Part numbers AMS3326(B, AMS4381, and AMS4381(B.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Reason for recall — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits…
123 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 26, 2016
Abdominoplasty Pack, Kit number AMS3326 convenience custom kits used for general surgery in hospital operating room
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand — The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes…
149 more products in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Laparotomy Pack, Part numbers 006268-8 and 007725-8. This is a custom convenience surgical instrument disposable kit.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand · Reason for recall — These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 16, 2015
AMS 4674 Custom Pack. For use in a general clinical procedure.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Windstone Medical Packaging, Inc.
Matched: Brand — AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
1 more product in this recall
FDA (openFDA device enforcement)
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