Windstone Medical Packaging, Inc.
Billings, MT, US
WINDSTONE MEDICAL PACKAGING, INC. appears in FDA device records in Billings, MT. FDA records list no 510(k) clearances, no PMA records and 2 registered establishments. As of , FDA records show 358 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Windstone Medical Packaging, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Windstone Medical, Inc.recall
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3025168 | 1000125955 | WINDSTONE MEDICAL PACKAGING, INC. | 1602 4th Ave N, BILLINGS, MT 59101 US | 2026 | |
| 3025686427 | 3025686427 | Windstone Medical Packaging, Inc. | 1400 Montana Ave., Billings, MT 59101 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
Showing 25 of 358| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2819-2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19 | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2818-2026 | 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 - RX, Part Number AMS11398C; 5) Radiology Tray-RX, Part Number AMS1217A; 6) Custom Pack - RX, Part Number AMS12757B; 7) Biopsy Tray w/Lidocaine - RX, Part Number AMS13700; 8) Arthrogram Tray - RX, Part Number AMS13755A; 9) Myelogram Tray - RX, Part Number AMS14805A; 10) Arthrogram Tray - RX, Part Number AMS15071A; 11) Vein Pack - RX, Part Number AMS15270; 12) Myelogram Tray - RX, Part Number AMS15298; 13) Loop Pack - RX, Part Number AMS15643; 14) Basic Biopsy Tray - RX, Part Number AMS15662A; 15) Pain Pack -RX, Part Number AMS17021; 16) Pain Tray -RX, Part Number AMS17817; 17) Vasectomy Pack - RX, Part Number AMS18226; 18) Arthrogram Tray- RX, Part Number AMS2886(A; 19) Custom Pack - RX, Part Number AMS3081C; 20) Basic Procedure Pack - RX, Part Number AMS5497; 21) Basic Pack - RX, Part Number AMS8130C; 22) Supply Kit - RX, Part Number AMS9521A; 23) Maximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2817-2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414 | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2816-2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2815-2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461 | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2814-2026 | 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. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2813-2026 | 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 - RX, Part Number AMS11314A; 4) Epidural Tray - RX, Part Number AMS11910A; 5) Nerve Block Tray - RX, Part Number AMS12171; 6) Single Shot Epidural Tray - RX, Part Number AMS12219A; 7) Universal Block Tray - RX, Part Number AMS12381B. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2812-2026 | AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (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 II | Open, Classified | |
| Z-2802-2026 | 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, Pack Number AMS14991B; 5) Spinal Pack, Pack Number AMS16278; 6) Spine Pack, Pack Number AMS16499; 7) Spine Pack, Pack Number AMS16709; 8) Lumbar Spine Pack, Pack Number AMS17336; 9) Laminectomy Pack, Pack Number AMS17945; 10) Anterior Cervical Pack, Pack Number AMS17946; 11) Spine Pack, Pack Number AMS3150F; 12) Spine Pack, Pack Number AMS3150G; 13) Spine Pack, Pack Number AMS5451D; 14) ENT Pack, Pack Number AMS9771. | 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. | Class II | Open, Classified | |
| Z-2801-2026 | 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 Number AMS16313; 5) Lami Kukkar Pack, Pack Number AMS17958; 6) Neuro Pack, Pack Number AMS6452B; 7) Neuro Lami Pack, Pack Number AMS9427C. | 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. | Class II | Open, Classified | |
| Z-2800-2026 | 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. | 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. | Class II | Open, Classified | |
| Z-2799-2026 | 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 AMS12636C; 5) Lumbar Lami Pack, Part Number AMS12731; 6) Septoplasty Pack, Part Number AMS13150; 7) Septoplasty Pack, Part Number AMS13150A; 8) Septoplasty Pack, Part Number AMS13150B; 9) Rhinoplasty Pack, Part Number AMS14496A; 10) Rhinoplasty Pack, Part Number AMS14496B; 11) Rhinoplasty Pack, Part Number AMS14496C; 12) Laryngoscopy Pack, Part Number AMS14736; 13) Nasal and Sinus Pack, Part Number AMS16417; 14) Major Pack, Part Number AMS16586; 15) Major Pack, Part Number AMS16586A; 16) Nasal and Sinus Pack, Part Number AMS7619A; 17) Sinus Pack, Part Number AMS7819A. | 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. | Class II | Open, Classified | |
| Z-2622-2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Dr. Lewin Pack, Pack Number AMS7200D, surgical convenience kit | 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. | Class I | Open, Classified | |
| Z-2621-2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Preop Kit-NS, Pack Number AMS18227, surgical convenience kit | 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. | Class I | Open, Classified | |
| Z-2620-2026 | A M S, ALIGNED MEDICAL SOLUTIONS, Thyroid FNA Pack-RX, Pack Number AMS17729, surgical convenience kit | 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. | Class I | Open, Classified | |
| Z-2619-2026 | A M S, ALIGNED MEDICAL SOLUTIONS, DSAEK Pack-RX, Pack Number AMS12394B, surgical convenience kit | 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. | Class I | Open, Classified | |
| Z-2307-2026 | Aligned Medical AMS16835 Fluids Kit RX | Lidocaine Hydrochloride Injection, USP, which was recalled by a supplier for quality issues, was included in custom convenience kits. | Class II | Open, Classified | |
| 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 | 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. | Class I | Open, Classified | |
| Z-1921-2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994A | 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). | Class II | Open, Classified | |
| Z-1920-2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994 | 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). | Class II | Open, Classified | |
| Z-1919-2026 | Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14433 | 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). | Class II | Open, Classified | |
| Z-0031-2025 | 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. | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Open, Classified | |
| Z-0030-2025 | 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. | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Open, Classified | |
| Z-0029-2025 | 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. | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Open, Classified | |
| Z-0028-2025 | 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. | Due to convenience kits containing a kit component that is under a recall action for improper use. | Class II | Open, Classified |
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Data as of , FDA export datePage updated Source: openFDA, public domain