Facility
WINDSTONE MEDICAL PACKAGING, INC.
20 recall(s) on record — most severe on record: Class I.
Activity by year
- Recalls (20)
- Inspections (1)
Devices registered here (1)
- Kit, Surgical Instrument, DisposableProduct code KDD (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4800
Recalls & enforcement
20267 records
- Class IIOngoing2026-07-29The convenience kits contain .0.9% Sodium Chloride Injection, USP products in Single Dose freeflex bags, which may contain blue Break-off-Parts (BOPs) that have detached from the infusion port during manipulation.
- Class IIOngoing2026-06-17Windstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris Medical Devices Inc. recalled the Lidocaine HCl injection USP due to supplier quality issues.
- Class IIOngoing2026-06-08The recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed® Neurological Sponges Non-Sterile Models 55992C to 55998C due to potential for unexpected variability of endotoxin levels on the products.
- Class IOngoing2026-05-21Kits contain Webcol Large Alcohol Prep Pad which were recalled by Cardinal Health following the discovery of a contaminant (Paenibacillus phoenicis) during a routine sterilization dose audit.
- Class IIOngoing2026-04-27Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
- Class IOngoing2026-04-02Affected kits contain Medline Namic RA Syringes, which are recalled by their manufacturer due to risk of syringe rotating adapter unwinding during use, which may result in a loose connection or full disconnection between syringe and manifold. If unwinding occurs, there is a poten…
- Class IIOngoing2026-03-11The 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 pot…
20241 record
- Class IIOngoing2024-08-16Due to convenience kits containing a kit component that is under a recall action for improper use.
20232 records
- Class IOngoing2023-12-22Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Class IIOngoing2023-04-24Light 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
20222 records
- Class IIOngoing2022-11-01Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
- Class IIOngoing2022-03-21Convenience 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 drug products.
20212 records
- Class IOngoing2021-08-19Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.
- Class IITerminated2021-04-08Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
20173 records
- Class IITerminated2017-10-24Custom surgical kits were manufactured with part #63310 Catheter Urethral 10FR 16" which were subsequently recalled by CR Bard for a potential sterile barrier breach.
- Class IITerminated2017-03-16AMS custom kits containing Medtronic Covidien Curity Eye Pad are recalled due to the potential for the sterile packaging of the eye pad to be compromised.
- Class IITerminated2017-01-11The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES of the custom Aligned Medical Solutions (AMS) kits were recalled because gloves may contain splits or holes compromising sterility.
20161 record
- Class IITerminated2016-03-21These packs contain item #4037 Kerlix X-ray Detectable Laparotomy Sponges which were recalled by Medtronic due to the potential for sterile barrier to be comprised at the packaging seal.
20152 records
- Class IITerminated2015-11-02AMS 4674 Custom Pack is recalled because this kit containing U-SDN 2 Part Ultra Modified Seldinger Needle which is recalled by supplier.
- Class IITerminated2015-04-22The Medtronic COVER LIGHT HANDLE DISPOSABLE GLOVES, Part # 13140, of the custom AMS kit were recalled because gloves may contain splits or holes compromising sterility.
FDA inspections (1)
- NAI2019-06-21No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices
Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “WINDSTONE MEDICAL PACKAGING, INC. (FEI 1000125955) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/1000125955-windstone-medical-packaging-inc/
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