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Windstone Medical Packaging Recalls
336 recalls on record · December 16, 2015 to August 5, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Loop Recorder Pack 2 -RX, Part Number AMS10164;
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Nerve Block Tray - RX, Part Number AMS13975A;
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Dr Fred Chiu Single Shot Epi Tray - Rx, Part Nu
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Laminectomy Pack, Pack Number AMS13574A; 2) A
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) Neuro Pack, Pack Number AMS12195C; 2) Neuro P
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Pack Number AMS12206; 2) ENT Pack,
Hazard: 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.
August 5, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1) ENT Pack, Part Number AMS10411B; 2) ENT Pack,
Hazard: 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.
July 8, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit
Hazard: 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.
July 8, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit
Hazard: 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.
July 8, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit
Hazard: 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.
July 8, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit
Hazard: 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.
June 10, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical AMS16835 Fluids Kit RX
Hazard: Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits.
May 20, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Custom Convenience Kit containing recalled Medline Namic Angiographic Control Syringes with Rotating Adapter (Namic RA S
Hazard: 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.
April 29, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A
Hazard: 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).
April 29, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994
Hazard: 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).
April 29, 2026Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433
Hazard: 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).
October 16, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Tonsil Pack REF AMS14809 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in
Hazard: Due to convenience kits containing a kit component that is under a recall action for improper use.
October 16, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical T and A Pack REF AMS11482 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in
Hazard: Due to convenience kits containing a kit component that is under a recall action for improper use.
October 16, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a
Hazard: Due to convenience kits containing a kit component that is under a recall action for improper use.
October 16, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Tonsil ENT Pack REF AMS9977 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged
Hazard: Due to convenience kits containing a kit component that is under a recall action for improper use.
October 16, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Tonsil Tray REF AMS9300A that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in
Hazard: Due to convenience kits containing a kit component that is under a recall action for improper use.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, Closure Kit, AMS13043, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947A STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.
February 28, 2024Medical DevicesFDA
Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, Local Lower Extremity Pack I, AMS10833, STERILEEO
Hazard: Sterility assurance for saline included in surgical kits cannot be guaranteed.