[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-warning-letter-genderbender-llc-720842-12162025":3,"fda-latest-sync-dates":31},{"id":4,"letter_id":5,"action_type":6,"firm_name":7,"fei_number":8,"issuing_office":9,"subject":10,"posted_date":11,"action_taken_date":12,"response_letter_date":8,"closeout_date":13,"case_status":14,"letter_url":15,"reference_number":8,"marcs_cms_no":16,"product_type":17,"delivery_method":18,"recipient_name":19,"recipient_title":8,"body_html":20,"body_text":21,"body_fetched_at":22,"medical_device_id":8,"raw":23,"created_at":29,"updated_at":30},404,"genderbender-llc-720842-12162025","Warning Letter","GenderBender LLC",null,"Center for Devices and Radiological Health","Failure to Register and List\u002FMisbranded","2025-12-18","2025-12-16","2026-04-02","Closed Out","https:\u002F\u002Fwww.fda.gov\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgenderbender-llc-720842-12162025","720842","Medical Devices","VIA Electronic Mail","Xandar Shephard","\n\n                            \n                            \n                            \n                            \n                                              \n  \n \n\n                 \n\n  \u003Chr>\n \n\n\u003Cdiv class=\"inset-column\">\n  \u003Cdl class=\"lcds-description-list--grid\">\n\n              \u003Cdt class=\"cell-1_1\">Delivery Method:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_1\">VIA Electronic Mail\n                                                                                                                                                                                                                                                                                                                                                                                                                              \u003C\u002Fdd>\n      \n      \n              \u003Cdt class=\"cell-1_3\">Product:\u003C\u002Fdt> \n        \u003Cdd class=\"cell-2_3\">Medical Devices                          \n            \n            \n            \n            \n            \n            \n            \n             \n            \n            \n            \n              \n            \n            \n            \u003C\u002Fdd>\n      \n          \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n\n\u003Chr>\n\n\u003Cdiv class=\"row inset-column\">\n  \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n\n        \u003Cdt>Recipient:\u003C\u002Fdt>\n\n                      \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-name field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Name\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Xandar Shephard\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n                                \u003Cdd>\n  \u003Cdiv class=\"field field--name-field-recipient-title field--type-string field--label-above\">\n    \u003Cdiv class=\"field--label\">Recipient Title\u003C\u002Fdiv>\n              \u003Cdiv class=\"field--item\">Manager\u003C\u002Fdiv>\n          \u003C\u002Fdiv>\n\u003C\u002Fdd>\n          \n            \u003Cdd>GenderBender LLC\u003C\u002Fdd>\n\n          \n                      \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"address-line1\">21042 S Main St\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"locality\">Carson\u003C\u002Fspan>, \u003Cspan class=\"administrative-area\">CA\u003C\u002Fspan> \u003Cspan class=\"postal-code\">90745\u003C\u002Fspan>\u003Cbr>\n\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n          \n          \n            \n            \u003Cdd>\u003C!-- Loop this field. For FDA Office content type. Display the Other contact channel is a dd span with an icon-->\n\n    \u003C\u002Fdd>\u003Cdd>\u003Cspan class=\"fa fa-envelope\" aria-hidden=\"true\">\u003C\u002Fspan>\u003Ca href=\"mailto:genderbenderapparel@gmail.com \"> genderbenderapparel@gmail.com \u003C\u002Fa>\u003C\u002Fdd>\n\n          \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>            \n\n       \u003Cdiv class=\"col-xs-12 col-md-6\">\n    \u003Cdl class=\"\">\n          \n          \u003Cdt>Issuing Office:\u003C\u002Fdt>\n        \n         \n          \u003Cdd>Center for Devices and Radiological Health\u003C\u002Fdd>\n        \n         \n          \u003Cdd>\u003Cp class=\"address\" translate=\"no\">\u003Cspan class=\"country\">United States\u003C\u002Fspan>\u003C\u002Fp>\u003C\u002Fdd>\n        \n        \n        \n        \n        \n    \u003C\u002Fdl>\n    \u003Cdl class=\"\"> \n      \n    \u003C\u002Fdl>\n  \u003C\u002Fdiv>  \n      \n\u003C\u002Fdiv>\n\n \n\n \n\n\u003Chr>\n\n\u003Cp class=\"text-align-center\">\u003Cstrong>WARNING LETTER\u003C\u002Fstrong>\u003Cbr>CMS #720842\u003C\u002Fp>\u003Cp>December 16, 2025\u003C\u002Fp>\u003Cp>Dear Xandar Shephard:\u003C\u002Fp>\u003Cp>The United States Food and Drug Administration (FDA) has reviewed GenderBender LLC’s (“your firm”) website (genderbenderllc.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\u003C\u002Fp>\u003Cp>Our review of your firm’s website revealed statements that these breast binders (example trade names: “Half Length Soft Binder with Zipper”, “Half Length Soft Binder”, “Full Length Soft Binder”, “3\u002F4 Length Soft Zip Binder for Large Cup Sizes, “Swimsafe Rigid Binder and Attachable Swim Tank”, “Swimsafe 3\u002F4-Length Deluxe Semi-Rigid Binder”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:\u003C\u002Fp>\u003Cul>\u003Cli>Per your firm’s website: “Chest binding is the practice of compressing breast mass into a more masculine shape, often done in the LGBTQ community for gender euphoria…but also practiced by cis men with gynecomastia.”\u003C\u002Fli>\u003Cli>Per your firm’s website: “Our compression wraps are perfect for wearing after top surgery to keep swelling down without needing to lift your arms.”\u003C\u002Fli>\u003C\u002Ful>\u003Cp>Our review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “These soft bands of high quality elastic are premade in sizes XS-4X, or we can custom-make larger sizes.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.\u003C\u002Fp>\u003Cp>Therefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).\u003C\u002Fp>\u003Cp>Your firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and injunction.\u003C\u002Fp>\u003Cp>Other federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.\u003C\u002Fp>\u003Cp>Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\u003C\u002Fp>\u003Cp>Your firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720842” when replying.\u003C\u002Fp>\u003Cp>Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.\u003C\u002Fp>\u003Cp>Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.\u003C\u002Fp>\u003Cp>Sincerely yours,\u003Cbr>\u002FS\u002F\u003C\u002Fp>\u003Cp>Michael J. Hoffmann  \u003Cbr>Director  \u003Cbr>Office of Health Technology 3 - Gastrorenal, ObGyn,\u003Cbr>General Hospital, and Urology Devices\u003Cbr>Office of Product Evaluation and Quality  \u003Cbr>Center for Devices and Radiological Health\u003Cbr>Food and Drug Administration\u003C\u002Fp>\u003Cp>cc: Shopify, Inc. abuse@shopify.com\u003C\u002Fp>\u003Cp>cc: gbllcservices@gmail.com\u003C\u002Fp>\n\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\u003C!--BEGIN QUALTRICS WEBSITE FEEDBACK SNIPPET-->\n\n\n\n              \n                                            \n              \n            ","Delivery Method:\n\nVIA Electronic Mail\n\nProduct:\n\nMedical Devices\n\nRecipient:\n\nRecipient Name\n\nXandar Shephard\n\nRecipient Title\n\nManager\n\nGenderBender LLC\n\n21042 S Main St\n\nCarson, CA 90745\n\nUnited States\n\ngenderbenderapparel@gmail.com\n\nIssuing Office:\n\nCenter for Devices and Radiological Health\n\nUnited States\n\nWARNING LETTER\nCMS #720842\nDecember 16, 2025\nDear Xandar Shephard:\nThe United States Food and Drug Administration (FDA) has reviewed GenderBender LLC’s (“your firm”) website (genderbenderllc.com) and observed that your website offers various breast binders for sale. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.\nOur review of your firm’s website revealed statements that these breast binders (example trade names: “Half Length Soft Binder with Zipper”, “Half Length Soft Binder”, “Full Length Soft Binder”, “3\u002F4 Length Soft Zip Binder for Large Cup Sizes, “Swimsafe Rigid Binder and Attachable Swim Tank”, “Swimsafe 3\u002F4-Length Deluxe Semi-Rigid Binder”) are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or intended to affect the structure or any function of the body, including:\nPer your firm’s website: “Chest binding is the practice of compressing breast mass into a more masculine shape, often done in the LGBTQ community for gender euphoria…but also practiced by cis men with gynecomastia.”\nPer your firm’s website: “Our compression wraps are perfect for wearing after top surgery to keep swelling down without needing to lift your arms.”\nOur review also revealed statements that you manufacture these devices within the meaning of section 510 of the Act (21 U.S.C. § 360) (e.g., “These soft bands of high quality elastic are premade in sizes XS-4X, or we can custom-make larger sizes.”). Under section 510 of the Act (21 U.S.C. § 360), manufacturers of medical devices are required to annually register with the FDA. In September 2007, section 510 of the Act was amended by the Food and Drug Administration Amendments Act of 2007 (Pub. L. 110-85) to require domestic and foreign device establishments to submit their annual establishment registration and device listing information to FDA by electronic means [section 510(p) of the Act (21 U.S.C. § 360(p))] during the period beginning October 1st and ending December 31st of each year. Our records indicate that you have not registered or listed these devices for fiscal year 2026.\nTherefore the devices are misbranded within the meaning of section 502(o) of the Act (21 U.S.C. § 352(0)), in that they were manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act (21 U.S.C. § 360) and were not included in a list required by section 510(j) of the Act (21 U.S.C. § 360(j)).\nYour firm should take prompt action to address any violations identified in this letter. Failure to adequately address this matter may result in regulatory action being initiated by the FDA without further notice. These actions include, but are not limited to, seizure and injunction.\nOther federal agencies may take your compliance with the FD&C Act and its implementing regulations into account when considering the award of federal contracts.\nPlease notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, as well as an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and\u002For corrective actions (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and\u002For corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and\u002For corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed. Your firm’s response should be comprehensive and address any violations included in this Warning Letter. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.\nYour firm’s response should be sent via email to CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS 720842” when replying.\nFinally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA.\nYour firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.\nSincerely yours,\n\u002FS\u002F\nMichael J. Hoffmann\nDirector\nOffice of Health Technology 3 - Gastrorenal, ObGyn,\nGeneral Hospital, and Urology Devices\nOffice of Product Evaluation and Quality\nCenter for Devices and Radiological Health\nFood and Drug Administration\ncc: Shopify, Inc. abuse@shopify.com\ncc: gbllcservices@gmail.com","2026-08-19T07:20:59.225+00:00",[24,25,26,9,10,27,28,27],"\u003Ctime datetime=\"2025-12-18T16:00:00Z\">12\u002F18\u002F2025\u003C\u002Ftime>\n","\u003Ctime datetime=\"2025-12-16T05:00:00Z\">12\u002F16\u002F2025\u003C\u002Ftime>\n","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgenderbender-llc-720842-12162025\">GenderBender LLC\u003C\u002Fa>","","\u003Ca href=\"\u002Finspections-compliance-enforcement-and-criminal-investigations\u002Fwarning-letters\u002Fgenderbender-llc-720842-03272026\">\u003Ctime datetime=\"2026-04-02T04:00:00Z\">04\u002F02\u002F2026\u003C\u002Ftime>\n\u003C\u002Fa>","2026-08-18T06:42:28.498414+00:00","2026-08-20T02:24:55.726997+00:00",{"510k":32,"classification":33,"enforcement":34,"event":35,"pma":36,"warning_letter":37},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00"]