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Windstone Medical Packaging, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 1000125955

Devices
0
Registrations
FDA
FDA recalls
33737 ongoing

No devices from this company are in the catalogue yet.

Company details

FDA FEI number
1000125955
Address
1602 4th Ave N, BILLINGS, MT, 59101

FDA recalls337

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 143
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 3
  • 2022 2
  • 2023 7
  • 2024 5
  • 2025 0
  • 2026 22

155 initiated before 2017

Showing the 10 most recent of 337 recalls.

  • 2026

    • 29 Jul 2026 Z-3138-2026 Class II Ongoing The 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. Distribution: US Nationwide distribution in the states of CA, GA, WA.
    • 17 Jun 2026 Z-2812-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2813-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2814-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2815-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2816-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2817-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2818-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 17 Jun 2026 Z-2819-2026 Class II Ongoing Windstone 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. Distribution: US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA,…
      Full distribution text US Nationwide distribution in the states of AZ, CA, CO, CT, FL, GA, IL, KS, LA, MA, MD, MN, MO, NH, NJ, NV, NY, OR, PA, TX, VA, WA.
    • 8 Jun 2026 Z-2799-2026 Class II Ongoing The 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. Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
Show the 25 most recent of 337 recalls

  • 2026

    • 8 Jun 2026 Z-2800-2026 Class II Ongoing The 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. Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
    • 8 Jun 2026 Z-2801-2026 Class II Ongoing The 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. Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
    • 8 Jun 2026 Z-2802-2026 Class II Ongoing The 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. Distribution: US Nationwide distribution in the states of AZ, CA, CT, GA, IL, MA, MD, NY, OH, PA, TN, TX, VA, WA.
    • 21 May 2026 Z-2619-2026 Class I Ongoing Kits 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. Distribution: US Nationwide distribution in the states of PA, GA, CA, WA.
    • 21 May 2026 Z-2620-2026 Class I Ongoing Kits 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. Distribution: US Nationwide distribution in the states of PA, GA, CA, WA.
    • 21 May 2026 Z-2621-2026 Class I Ongoing Kits 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. Distribution: US Nationwide distribution in the states of PA, GA, CA, WA.
    • 21 May 2026 Z-2622-2026 Class I Ongoing Kits 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. Distribution: US Nationwide distribution in the states of PA, GA, CA, WA.
    • 27 Apr 2026 Z-2307-2026 Class II Ongoing Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. Distribution: US Nationwide distribution in the states of IL, VA.
    • 2 Apr 2026 Z-2066-2026 Class I Ongoing Affected 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 potential for biohazard exposure, blood loss, infection. or air embolism. Distribution: US Nationwide distribution in the state of Arizona.
    • 11 Mar 2026 Z-1919-2026 Class II Ongoing 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). Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.
    • 11 Mar 2026 Z-1920-2026 Class II Ongoing 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). Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.
    • 11 Mar 2026 Z-1921-2026 Class II Ongoing 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). Distribution: US Nationwide distribution in the states of GA, OR, TN, and WA.

  • 2024

    • 16 Aug 2024 Z-0027-2025 Class II Ongoing Due to convenience kits containing a kit component that is under a recall action for improper use. Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
    • 16 Aug 2024 Z-0028-2025 Class II Ongoing Due to convenience kits containing a kit component that is under a recall action for improper use. Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.
    • 16 Aug 2024 Z-0029-2025 Class II Ongoing Due to convenience kits containing a kit component that is under a recall action for improper use. Distribution: U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.

This is an FDA establishment record without devices in deviCERTS.