{"recall":{"id":"fda-device-99347","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Windstone Medical Packaging, Inc. recalls 8 products","firm":"Windstone Medical Packaging, Inc.","date":"2026-06-17","reported":"2026-08-05","status":"Ongoing","classification":"Class II","products":[{"name":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: SPINAL KIT, Part Number AMS13683A","code":"UDI/DI B098AMS13683A0, Lot Number 230451","quantity":"15 kits","number":"Z-2812-2026","classification":"Class II"},{"name":"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.","code":"Part Number AMS1095(E, UDI/DI B098AMS1095(E0; Lot Numbers: 231043; Part Number AMS11296A, UDI/DI B098AMS11296A0; Lot Numbers: 229846; Part Number AMS11314A, UDI/DI B098AMS11314A0; Lot Numbers: 216803, 240843; Part Number AMS11910A, UDI/DI B098AMS11910A0; Lot Numbers: 230645, 231078; Part Number AMS12171, UDI/DI B098AMS121710; Lot Numbers: 230958, 231238, 241232; Part Number AMS12219A, UDI/DI B098AMS12219A0; Lot Numbers: 217313; Part Number AMS12381B, UDI/DI B098AMS12381B0; Lot Numbers: 230948.","quantity":"580 kits","number":"Z-2813-2026","classification":"Class II"},{"name":"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.","code":"Part Number AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers: 230376, 241103; Part Number AMS2009, UDI/DI B098AMS20090, Lot Numbers: 216938, 240939; Part Number AMS3224, UDI/DI B098AMS32240, Lot Numbers: 231314.","quantity":"950 kits","number":"Z-2814-2026","classification":"Class II"},{"name":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Angio Pack - RX, Part Number AMS9461","code":"UDI/DI B098AMS94610, Lot Numbers: 230658, 231173.","quantity":"60 kits","number":"Z-2815-2026","classification":"Class II"},{"name":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Heart Cath Tray - RX, Part Number DDS1159B","code":"UDI/DI B098DDS1159B0, Lot Numbers: 214412.","quantity":"24 kits","number":"Z-2816-2026","classification":"Class II"},{"name":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Block Tray - RX, Part Number AMS12414","code":"UDI/DI B098AMS124140, Lot Numbers: 230411.","quantity":"100 kits","number":"Z-2817-2026","classification":"Class II"},{"name":"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.","code":"Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers: 230816; Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers: 230588, 230589, 230590, 230893, 241165; Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers: 215784, 231259, 241171; Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers: 230680; Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers: 217313; Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers: 240360; Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers: 217431; Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers: 230376, 241103; Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers: 217790; Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers: 230689; Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers: 230667; Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers: 216398; Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers: 241219; Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers: 241307; Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers: 230737, 231023; Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers: 241136; Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers: 241031; Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers: 230745; Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers: 230716; Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers: 230851; Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers: 217634, 217635, 231235, 231236, 240963; Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers: 217055; Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers: 217429.","quantity":"3378 kits","number":"Z-2818-2026","classification":"Class II"},{"name":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: Port Tray - RX, Part Number 008786-19","code":"UDI/DI B098008786190, Lot Numbers: 230451.","quantity":"15 kits","number":"Z-2819-2026","classification":"Class II"}],"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.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"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.","nationwide":true,"states":[],"units":"15 kits; 580 kits; 950 kits; 60 kits; 24 kits; 100 kits; 3378 kits; 15 kits","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99347","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"544e7361cda13b03","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99347","record":[{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2812-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  SPINAL KIT, Part Number AMS13683A","product_quantity":"15 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"UDI/DI B098AMS13683A0, Lot Number  230451"},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2813-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tDr Fred Chiu Single Shot Epi Tray - Rx, Part Number AMS1095(E ;   2)\tSingle Shot Epidural Tray - RX, Part Number AMS11296A;   3)\tNerve Block Tray - RX, Part Number AMS11314A;   4)\tEpidural Tray - RX, Part Number AMS11910A;   5)\tNerve Block Tray - RX, Part Number AMS12171;   6)\tSingle Shot Epidural Tray - RX, Part Number AMS12219A;   7)     Universal Block Tray - RX, Part Number AMS12381B.","product_quantity":"580 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"Part Number AMS1095(E, UDI/DI B098AMS1095(E0;  Lot Numbers: 231043;  Part Number AMS11296A, UDI/DI B098AMS11296A0;  Lot Numbers: 229846;  Part Number AMS11314A, UDI/DI B098AMS11314A0;  Lot Numbers: 216803, 240843;  Part Number AMS11910A, UDI/DI B098AMS11910A0;  Lot Numbers: 230645, 231078;  Part Number AMS12171, UDI/DI B098AMS121710;  Lot Numbers: 230958, 231238, 241232;  Part Number AMS12219A, UDI/DI B098AMS12219A0;  Lot Numbers: 217313;  Part Number AMS12381B, UDI/DI B098AMS12381B0;  Lot Numbers: 230948."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2814-2026","product_description":"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.","product_quantity":"950 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"Part Number AMS13975A, UDI/DI B098AMS13975A0, Lot Numbers:  230376, 241103;  Part Number AMS2009, UDI/DI B098AMS20090, Lot Numbers:  216938, 240939;  Part Number AMS3224, UDI/DI B098AMS32240, Lot Numbers:  231314."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2815-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Angio Pack - RX, Part Number AMS9461","product_quantity":"60 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"UDI/DI B098AMS94610, Lot Numbers: 230658, 231173."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2816-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Heart Cath Tray - RX, Part Number DDS1159B","product_quantity":"24 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"UDI/DI B098DDS1159B0, Lot Numbers: 214412."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2817-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Block Tray - RX, Part Number AMS12414","product_quantity":"100 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"UDI/DI B098AMS124140, Lot Numbers: 230411."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2818-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:    1)\tLoop Recorder Pack 2 -RX, Part Number AMS10164;   2)\tNY Tray - RX, Part Number AMS10276A;   3)\tNYC Tray - RX, Part Number AMS10281B;   4)\tVein Pack - RX, Part Number AMS11398C;   5)\tRadiology Tray-RX, Part Number AMS1217A;   6)\tCustom Pack - RX, Part Number AMS12757B;   7)\tBiopsy Tray w/Lidocaine - RX, Part Number AMS13700;   8)\tArthrogram Tray - RX, Part Number AMS13755A;   9)\tMyelogram Tray - RX, Part Number AMS14805A;   10)\tArthrogram Tray - RX, Part Number AMS15071A;   11)\tVein Pack - RX, Part Number AMS15270;   12)\tMyelogram Tray - RX, Part Number AMS15298;   13)\tLoop Pack - RX, Part Number AMS15643;   14)\tBasic Biopsy Tray - RX, Part Number AMS15662A;   15)\tPain Pack -RX, Part Number AMS17021;   16)\tPain Tray -RX, Part Number AMS17817;   17)\tVasectomy Pack - RX, Part Number AMS18226;   18)\tArthrogram Tray- RX, Part Number AMS2886(A;   19)\tCustom Pack - RX, Part Number AMS3081C;   20)\tBasic Procedure Pack - RX, Part Number AMS5497;   21)\tBasic Pack - RX, Part Number AMS8130C;   22)\tSupply Kit - RX, Part Number AMS9521A;   23)\tMaximal Sterile Barrier Vascular Access Procedure Kit - RX, Part Number VK0003MB.","product_quantity":"3378 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"Part Number AMS10164, UDI/DI B098AMS101640, Lot Numbers:  230816;  Part Number AMS10276A, UDI/DI B098AMS10276A0, Lot Numbers:  230588, 230589, 230590, 230893, 241165;  Part Number AMS10281B, UDI/DI B098AMS10281B0, Lot Numbers:  215784, 231259, 241171;  Part Number AMS11398C, UDI/DI B098AMS11398C0, Lot Numbers:  230680;  Part Number AMS1217A, UDI/DI B098AMS1217A0, Lot Numbers:  217313;  Part Number AMS12757B, UDI/DI B098AMS12757B0, Lot Numbers:  240360;  Part Number AMS13700, UDI/DI B098AMS137000, Lot Numbers:  217431;  Part Number AMS13755A, UDI/DI B098AMS13755A0, Lot Numbers:  230376, 241103;  Part Number AMS14805A, UDI/DI B098AMS14805A0, Lot Numbers:  217790;  Part Number AMS15071A, UDI/DI B098AMS15071A0, Lot Numbers:  230689;  Part Number AMS15270, UDI/DI B098AMS152700, Lot Numbers:  230667;  Part Number AMS15298, UDI/DI B098AMS152980, Lot Numbers:  216398;  Part Number AMS15643, UDI/DI B098AMS156430, Lot Numbers:  241219;  Part Number AMS15662A, UDI/DI B098AMS15662A0, Lot Numbers:  241307;  Part Number AMS17021, UDI/DI B098AMS170210, Lot Numbers:  230737, 231023;  Part Number AMS17817, UDI/DI B098AMS178170, Lot Numbers:  241136;  Part Number AMS18226, UDI/DI B098AMS182260, Lot Numbers:  241031;  Part Number AMS2886(A, UDI/DI B098AMS2886(A0, Lot Numbers:  230745;  Part Number AMS3081C, UDI/DI B098AMS3081C0, Lot Numbers:  230716;  Part Number AMS5497, UDI/DI B098AMS54970, Lot Numbers:  230851;  Part Number AMS8130C, UDI/DI B098AMS8130C0, Lot Numbers:  217634, 217635, 231235, 231236, 240963;  Part Number AMS9521A, UDI/DI B098AMS9521A0, Lot Numbers:  217055;  Part Number VK0003MB, UDI/DI 00813623010666, Lot Numbers:  217429."},{"status":"Ongoing","city":"Billings","state":"MT","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99347","recalling_firm":"Windstone Medical Packaging, Inc.","address_1":"1602 4th Ave N","address_2":"N/A","postal_code":"59101-1521","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"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.","recall_number":"Z-2819-2026","product_description":"AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as:  Port Tray - RX, Part Number 008786-19","product_quantity":"15 kits","reason_for_recall":"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.","recall_initiation_date":"20260617","center_classification_date":"20260727","report_date":"20260805","code_info":"UDI/DI B098008786190, Lot Numbers:  230451."}]}}