Billings, MT, United States
Windstone Medical Packaging, Inc. recalls
14 recalls recorded since 2018, most recently on 29 July 2026. 13 are listed as ongoing. Status and classification are as published by the FDA.
Recalls14
Ongoing (FDA)13
Terminated or completed1
Class I (FDA)4
Ongoing Class II Medical devices
- Recall started
- 29 July 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-3138-2026
- AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B
Ongoing Class II Medical devices
- Recall started
- 17 June 2026
- Reason
- 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, TX, VA, WA.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2814-2026, Z-2818-2026, Z-2819-2026, Z-2816-2026, Z-2817-2026, Z-2812-2026, Z-2813-2026, Z-2815-2026
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A; 2) Universal Block Tray- RX, Part Number AMS2009; 3) Nerve Block Tray - RX, Part Number AMS3224.
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164; 2) NY Tray - RX, Part Number AMS10276A; 3) NYC Tray - RX, Part Number AMS10281B; 4) Vein Pack
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ; 2) Single Shot Epidural Tray - RX, Part Number AMS11296A; 3) Nerve Block Tray -
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Ongoing Class II Medical devices
- Recall started
- 8 June 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2800-2026, Z-2801-2026, Z-2799-2026, Z-2802-2026
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack, Pack Number AMS15517; 3) ENT Facial Pack, Pack Number AMS15863A.
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro Pack, Pack Number AMS12195D; 3) Neuro Pack, Pack Number AMS12307; 4) Neuro Spine Pack, Pack Numbe
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack, Part Number AMS10411C; 3) Rhinoplasty Pack, Part Number AMS11963A; 4) Spine Pack, Part Number A
- AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) ACDF/Fusion Pack, Pack Number AMS14710B; 3) Spine Pack, Pack Number AMS14991A; 4) Spine Pack, Pac
Ongoing Class I Medical devices
- Recall started
- 21 May 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2622-2026, Z-2620-2026, Z-2619-2026, Z-2621-2026
- A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
- A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
- A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
- A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Ongoing Class II Medical devices
- Recall started
- 27 April 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2307-2026
- Aligned Medical AMS16835 Fluids Kit RX
Ongoing Class I Medical devices
- Recall started
- 2 April 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2066-2026
- Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA Syringes) Angio Pack Part numbers AMS6908E, AMS6908F
Ongoing Class II Medical devices
- Recall started
- 11 March 2026
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1920-2026, Z-1921-2026, Z-1919-2026
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
- Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Ongoing Class II Medical devices
- Recall started
- 16 August 2024
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0029-2025, Z-0030-2025, Z-0027-2025, Z-0031-2025, Z-0028-2025
- 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.
- 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.
- 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.
- 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.
- 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.
Ongoing Class I Medical devices
- Recall started
- 22 December 2023
- Reason
- Sterility assurance for saline included in surgical kits cannot be guaranteed.
- Distribution
- US: FL, IL, CA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1081-2024, Z-1080-2024, Z-1082-2024, Z-1079-2024
- Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
- Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
- Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
- Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Ongoing Class II Medical devices
- Recall started
- 24 April 2023
- Reason
- 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
- Distribution
- US: MA OUS: None
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1621-2023, Z-1620-2023, Z-1619-2023
- Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Aligned Medical Solutions Minor Hand Pack, REF: AMS6539E, containing P 2 Cover Light Handle Blue STE, Sterile EO
- Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Ongoing Class II Medical devices
- Recall started
- 1 November 2022
- Reason
- Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0881-2023
- Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A Nasal Endoscopy Pack AMS10710A Ultrasound Tray w/PDI AMS11941 Total Knee Pack AMS12138B Ey
Ongoing Class II Medical devices
- Recall started
- 21 March 2022
- Reason
- 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 drug products.
- Distribution
- US: PA, WA, FL, GA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1101-2022
- Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports Cath Pack (1794)/AMS6569, Minor Procedure Pack (20527)/AMS6570B, Breast Biops
Ongoing Class I Medical devices
- Recall started
- 19 August 2021
- Reason
- Monoject 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.
- Distribution
- FL and PA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0119-2022
- Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP
Terminated Class II Medical devices
- Recall started
- 8 April 2021
- Terminated
- 15 December 2022
- Reason
- Angio tubing included within Custom Convenience kits may contain insufficient or incomplete weld
- Distribution
- US Nationwide distribution in the state of AZ.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1848-2021, Z-1849-2021
- Angio Pack REF: AMS6908C, Sterile EO, Contents:1 Blade Scalpel # 11 SS 1 Bowl Guidewire 80 oz 4 Clamp Towel 2.5 1 Cover Probe 6X48 NS 2 Gown Surgical STD XLG NR 16 Label Custom 1 Counter Needle Nest 40 Sponge 4x4
- Angio Pack REF: AMS8050A, Sterile EO, Contents:2 Glove Dermassist 7.5 PF PR S 1 Bowl Fluid Containment W/LI 1 Cover Probe 6 X 48 NS 2 Gown surgical STD XLG NR 1 Needle RB 18x1.5 1 Spike Bag Decanter 2 Syringe 20CC
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.