{"recall":{"id":"fda-device-99699","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Custom Interventional Pain Management, LLC recalls Brand Name: Ferndale Laboratories","firm":"Custom Interventional Pain Management, LLC","date":"2026-01-15","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM Product Name: Mastisol Skin Adhesive Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM) Software Version: n/a Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures. Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of regional anesthesia. Component: surgical kits","code":"Lot Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray; Item #110026; Received Lot# 27022; Affected Lot #1225271; Expiration Date: 01/31/2028; DHR or Batch Record #64591; UDI: *+B87517LIDO/$$20131281225271T* UDI- DI #: B87517LID0 with Lidocaine","quantity":"56","number":"Z-0067-2027","classification":"Class II"}],"reason":"Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"U.S. Nationwide distribution in the state of TX.","nationwide":true,"states":[],"units":"56","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=99699","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"7d3903eb264e8899","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=99699","record":[{"status":"Ongoing","city":"San Antonio","state":"TX","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99699","recalling_firm":"Custom Interventional Pain Management, LLC","address_1":"12460 Network Blvd Ste 106","address_2":"","postal_code":"78249-3366","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"U.S. Nationwide distribution in the state of TX.","recall_number":"Z-0067-2027","product_description":"Brand Name: Ferndale Laboratories; Medline; Custom Interventional Pain Management CIPM  Product Name: Mastisol Skin Adhesive  Model/Catalog Number: 24161B (Ferndale and Medline); Tray 17025 17g continuous PBN tray (CIPM)  Software Version: n/a  Product Description: Skin Adhesive in a narrow plastic sterilized tube. Mastisol is a skin glue often used during surgical procedures.  Continuous epidural trays are designed for use by anesthesiologists and radiologists in the administration of  regional anesthesia.  Component: surgical kits","product_quantity":"56","reason_for_recall":"Due to manufacturing issues with the liquid skin adhesive containing in surgical convenience trays/kits.","recall_initiation_date":"20260115","center_classification_date":"20261001","report_date":"20261007","code_info":"Lot Code: CIPM product / reorder #17025; Description: 17g continuous PBN tray; Item #110026; Received Lot# 27022; Affected Lot #1225271; Expiration Date: 01/31/2028; DHR or Batch Record #64591; UDI: *+B87517LIDO/$$20131281225271T* UDI- DI #: B87517LID0 with Lidocaine","more_code_info":""}]}}